This page shows what was measured, who it was measured in, and what that does not settle.
What Dabigatran etexilate does in the body
Preventing strokes in an irregular heartbeat, and treating clots in the legs and lungs
Clotting is a chain of enzymes, and thrombin is the last one in the chain: it converts a soluble protein into the fibrin mesh that holds a clot together. Warfarin works upstream, by starving the liver of the vitamin K it needs to build several of those enzymes, which is why it takes days to work and why food changes its effect. Dabigatran skips all of that and plugs the business end of thrombin directly. The capsule itself is inactive; enzymes in your gut wall and liver clip two chemical caps off it to release the working drug.
What happened in people
Stroke or systemic embolism 1.11% per year at 150 mg twice daily against 1.69% on warfarin, RR 0.66 (0.53-0.82), in 18,113 randomised patients
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The recorded finding that sits closest to something a person would notice. Written into the record, not signed off, and it carries no population or interval.
Contraindicated in mechanical heart valves, which is a label change written directly out of a failed trial
Where it acts
Blood plasma — the active site of circulating thrombin
Kind of result
Living longer, or avoiding a major event
Supervision
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.
What the registries record it as
The substance registry classes this as chemical.
FDA substance registry · SC7NUW5IIT · read 2026-08-29
Its recorded molecular formula is C34H41N7O5·CH3SO3H, weighing 723.86.
US prescribing information · d5937f27-88c7-4c4a-801e-4c8945008982 · read 2026-08-30
Where each sentence above came from
No recorded sentence describes the change this makes in a way that stands on its own. The page opens with what it is taken for instead, and the recorded explanation follows below.
Shown as the opening line on this page.
A limit recorded against this substance. Not signed off as a reviewed claim.
The four opening statements run to 143 words.
Words this page uses
Four words worth knowing first
Chosen from what this page shows, with each one explained before the word it depends on.
Stand-in result
A stand-in result is a number measured because the real result takes too long.
A picture of it, and where the picture fails
It is like judging a journey by the speedometer rather than by arriving.
Where that stops being true. Speed does predict arrival. Many stand-in results do not predict the real one.
What people get wrong. A stand-in result is often reported as the result itself.
A surrogate endpoint substituted for a clinical endpoint, valid only where the substitution has been shown to hold.
Randomisation
Randomisation means chance decides who gets which treatment.
A picture of it, and where the picture fails
It is like a coin toss deciding the groups.
Where that stops being true. A coin toss is fair once. Fairness here comes from doing it for everyone.
What people get wrong. It is thought to make groups identical. It makes them similar on average, including on things nobody measured.
Allocation of participants to arms by a chance process, so that unmeasured factors are balanced in expectation.
Absolute difference
An absolute difference is how many more people in a hundred were affected.
A picture of it, and where the picture fails
It is like counting heads in two rooms of a hundred.
Where that stops being true. Heads are easy to count. Study results carry a margin of error too.
What people get wrong. It is confused with a percentage change, which can look far larger.
The arithmetic difference in event rates between arms.
Confidence interval
A confidence interval is the range the true answer is likely to sit in.
A picture of it, and where the picture fails
It is like a weather forecast giving a range rather than one number.
Where that stops being true. A forecast range covers tomorrow. This one covers what the study could resolve.
What people get wrong. The middle number is read as the answer. A range crossing zero means no change is still possible.
An interval estimate that would contain the true parameter in a stated proportion of repeated studies.
What happened in people◇Read from sources, not yet reviewed
What was measured, goal by goal
One row for each goal a registered study measured something for. One column for each kind of thing that could be measured.
Registered studies list 40 outcome measures that RNAWiki could read. A registered study says what someone planned to measure. It does not say what they found. 0 of the matched studies tested this substance, and 0 posted a result.
There is no single score. A strong test result and a weak life result are different facts.
Goals down the side, kinds of measurement across the top. Each cell says what kind of thing was registered, not what was found.
Goal
Life outcome
What a body can do
How a person feels
A test result
A step in the body
Harms
How long
Who was studied
Focus
∅Nothing in the sources checkedNo registered study lists a life outcome for this goal.
∅Nothing in the sources checkedNo registered study lists a performance measure for this goal.
∅Nothing in the sources checkedNo registered study lists a symptom measure for this goal.
∅Nothing in the sources checkedNo registered study lists a test result for this goal.
∅Nothing in the sources checkedNo registered study lists a body-step measure for this goal.
—Not recordedHarms were not a registered measure for this goal.
—Not recordedNo finished study window is recorded.
…Waiting for a reviewerWho was studied is listed further down the page.
Which registered measures put each goal on this table
Focus
cognitive impairment
Sorted by fixed word lists, version v1. A name the rules do not recognise stays unsorted rather than moving to the nearest column.
What each mark on this table means
∅ Nothing in the sources checked
No registered study lists a life outcome for this goal.
— Not recorded
Harms were not a registered measure for this goal.
… Waiting for a reviewer
Who was studied is listed further down the page.
What happened in people◇Read from sources, not yet reviewed
What happened in people
Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.
Stroke or systemic embolism, dabigatran 110 mg or 150 mg twice daily versus adjusted-dose warfarin
✓ The study showed what it set out to show
Who was studied
RE-LY (NCT00262600)
How many people
18113
Study design
Phase 3 randomised trial, partially blinded, median 2.0 years
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
150 mg: 1.11% vs 1.69% per year, RR 0.66 (95% CI 0.53 to 0.82), p<0.001 for superiority. 110 mg: 1.53% per year, RR 0.91 (0.74 to 1.11), p<0.001 for non-inferiority
Repeated elsewhere
Partially Replicated
What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.
The limits of this study, and where it came from
Main limit. Major bleeding was not reduced at 150 mg (3.11% vs 3.36% per year, p=0.31). The warfarin arm was unblinded. Additional previously unidentified events were reported in a letter to the New England Journal of Medicine a year after publication.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral capsule containing acid-core pellets, taken twice daily
Interval reported. 95% CI 0
Written into the record, not signed off as a reviewed claim.
Trough plasma dabigatran concentration in patients with mechanical aortic or mitral valves, with clinical events observed
✗ The study did not show it
Who was studied
RE-ALIGN (NCT01452347)
How many people
252
Study design
Phase 2 dose-validation randomised trial, terminated early
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Terminated for excess events: ischaemic or unspecified stroke in 9 of 162 dabigatran patients (5%) versus 0 of 90 on warfarin; major bleeding 4% versus 2%, all pericardial
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. Dose adjustment or discontinuation was required in 32% of dabigatran patients despite a protocol that targeted a measured plasma level.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral capsule containing acid-core pellets, taken twice daily
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
Maximum percentage reversal of anticoagulant effect within four hours of idarucizumab, by dilute thrombin time or ecarin clotting time
✓ The study showed what it set out to show
Who was studied
RE-VERSE AD (NCT02104947)
How many people
503
Study design
Phase 3 prospective open-label single-arm cohort study
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Median maximum reversal 100% (95% CI 100 to 100)
Repeated elsewhere
Unreplicated
What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.
The limits of this study, and where it came from
Main limit. Single-arm with no control. Ninety-day mortality was 18.8% and 18.9% in the two groups, which describes the severity of the population rather than the effect of the antidote.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral capsule containing acid-core pellets, taken twice daily
Interval reported. 95% CI 100 to 100)
Written into the record, not signed off as a reviewed claim.
Ischaemic stroke, intracranial haemorrhage, major gastrointestinal bleeding, myocardial infarction and death, dabigatran versus warfarin in routine care
✓ The study showed what it set out to show
Who was studied
FDA Medicare cohort (Graham et al., Circulation 2015)
What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.
The limits of this study, and where it came from
Main limit. Observational. Most patients on the 75 mg twice-daily strength did not appear to have the severe renal impairment that strength was intended for, which is a prescribing finding rather than a drug finding.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral capsule containing acid-core pellets, taken twice daily
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
RNAWiki holds 4 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.
What happened in people◇Read from sources, not yet reviewed
How close this is to real life
The top step is something a person would feel or care about. The bottom is a guess from software. Filled steps are where evidence exists for this substance.
■Living longer, or avoiding a major eventEvidence recorded. Death, a heart attack, a stroke, a hospital stay.2 registered measures of this kind. No reviewed result.
□What a body can do day to dayNo evidence recorded. Walking, dressing, breathing, recovering.No registered study measures this.
□Measured performanceNo evidence recorded. How much was lifted, how far was run, how fast.No registered study measures this.
□Symptoms and quality of lifeNo evidence recorded. Pain, tiredness, mood, sleep, as the person rated it.No registered study measures this.
■A number that stands in for healthEvidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.6 registered measures of this kind.
■A step measured inside a personEvidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
□AnimalsNo evidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.No animal record is stored.
□Cells in a dishNo evidence recorded. Cells or chemistry on a bench, far from a whole body.No cell or bench record is stored.
□A guess from softwareNo evidence recorded. Nobody measured it. RNAWiki never publishes one as a finding.RNAWiki stores no prediction for this record. Software can suggest a link. RNAWiki does not publish one as a finding.
Higher on these steps means closer to something a person would feel. It does not mean better done.
What it changes in the body◇Read from sources, not yet reviewed
The path through the body
From what a person takes to what changes. A solid line is a step measured in people. A dashed line is a step nobody has measured that way.
Start
Dabigatran etexilate
What a person takes: Oral capsule containing acid-core pellets, taken twice daily.
The measurement behind this step
The capsule shell holds pellets whose cores are tartaric acid, because the drug dissolves only in an acidic microenvironment. Opening, chewing or crushing the capsule raises absorption substantially and is specifically warned against on the label. Bottles carry a use-by period after opening because the pellets are moisture-sensitive.
Getting in
A capsule that carries its own acid
The active drug only dissolves in acid, so each capsule contains tiny pellets with a core of tartaric acid. That is why the capsule must not be opened or crushed.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Dabigatran etexilate mesylate is layered onto tartaric acid core pellets to create an acidic microenvironment independent of stomach pH. Absolute oral bioavailability is roughly 6 to 7%; breaching the capsule raises exposure substantially and is a real risk rather than a formulation nicety.
What you swallow does nothing. Enzymes in the gut wall and the liver snip off two protective groups, and only then does the working drug exist.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
A double prodrug. Carboxylesterase 2 in the intestine removes the ethyl ester and carboxylesterase 1 in the liver removes the hexyloxycarbonyl carbamate, releasing the free benzamidine. The intact prodrug is also a P-glycoprotein substrate, which is why verapamil and amiodarone raise its levels and rifampicin lowers them.
It plugs the pocket thrombin uses to grip its target
Thrombin recognises what to cut by fitting part of that protein into a deep pocket. The drug sits in the pocket instead, so nothing else can.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
The benzamidine inserts into the S1 specificity pocket and forms a salt bridge with aspartate 189, the residue that normally holds the arginine of fibrinogen. Binding is reversible and competitive, and it inhibits free thrombin as well as thrombin already bound within a clot — the latter being something heparin cannot do, because heparin works through antithrombin and cannot reach clot-bound thrombin.
Fibrinogen is never cut, so the mesh is never built
Without thrombin doing its cutting, the soluble protein that would become the clot scaffold stays soluble. Platelets can still gather, but nothing sets.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Blocking thrombin prevents cleavage of fibrinogen to fibrin monomer, prevents activation of factor XIII that would cross-link the mesh, and removes thrombin’s own feedback amplification of factors V, VIII and XI. It also blunts thrombin-mediated platelet activation through PAR-1.
Fewer strokes, and bleeding moved from the brain to the gut
Over two years, fewer clots reached the brain. The bleeding that a blood thinner always causes shifted: much less inside the skull, somewhat more in the stomach and bowel.
──Measured in people. Written by a person from the study named beside the step. Not signed off as a reviewed claim.
The measurement behind this step
In RE-LY, stroke or systemic embolism 1.11% per year at 150 mg against 1.69% on warfarin; haemorrhagic stroke 0.10% against 0.38%; major bleeding 3.11% against 3.36% (not significant). In 134,414 Medicare patients, intracranial haemorrhage hazard ratio 0.34 and major gastrointestinal bleeding 1.28. Roughly 80% of absorbed active drug is renally cleared, so falling kidney function raises exposure and raises bleeding.
No suggested links are held for this record, so nothing is hidden from this path.
What we know
The record describes 5 steps from taking it to an effect in a person.
How we know it
Each step names the study behind it in the technical detail beside it.
What this does not prove
A change inside the body is a reason to look. It is not a result in a person.
Why it matters
A reader can see exactly where the chain stops being measured in people.
What we still do not know
No reviewed claim binds any of these steps to a named population.
What it would be like to take◇Read from sources, not yet reviewed
Felt, measured, or meaningful
Three different things that get called the same word. Registered studies measured all three, and mixing them is how a blood test becomes a health claim.
Felt
Things a person could notice without a test.
No registered study measured anything of this kind.
Measured
Things only a test, a scale or a device shows.
plasma concentration of free dabigatran
plasma concentration of total dabigatran
level of fibrin degradation product
level of fibrinopeptide a
level of prothrombin split products
level of thrombin antithrombin complex
Meaningful
Things that change how a life goes, not only a number.
composite of recurrent vte or vte death at 36 months
composite of recurrent vte or vte death at 18 months
A registered study says what someone planned to measure. It does not say what they found. A number moving is not the same as a life going better. The two are shown apart here.
Felt, but not shown to help. A person notices a change. No study showed it leads anywhere good.
Measured, but not felt. A number moves. The person notices nothing. Both can be true.
Measured, but not shown to matter. A number moves in the good direction. Nobody showed that lives went better.
Matters, but takes years. The result that counts may take longer than anyone would keep watching.
Names that fit none of the three (32)
bleeding events
adverse events
cmax
tmax
frequency of major bleeding event
frequency of clinically relevant bleeding event
frequency of nuisance bleeding event
incidence and severity of adverse events
discontinuation of the study drug due to adverse events
changes in laboratory test values
vitro reversal of anticoagulation
venous thromboembolic events
major bleeding events
total dabigatran area under the curve 0 to infinity
adp induced platelet aggregation
microbleeds on mri
incidence of peri procedural major bleeding complications
modifications in hemostasis parameters
frequency of adverse drug reactions
fibrosis
These are harms, study-process measures, or names the rules did not recognise. They are shown rather than dropped.
What it would be like to take◇Read from sources, not yet reviewed
How long anything takes
Nine different lengths of time that get confused with each other. None of them is worked out from another.
Before anything is noticed.RNAWiki does not store this separately, and never works it out from another figure on this page.
Before a test result moves.RNAWiki does not store this separately, and never works it out from another figure on this page.
Before performance moves.RNAWiki does not store this separately, and never works it out from another figure on this page.
How long the result was watched.No finished study window is recorded for a study that tested this substance.
How long people took it.How long people actually took it is not stored. The study window is not the same thing.
How long people were followed.Follow-up length is not stored separately. It is never read off the study window, which would be a different thing.
How fast the body clears it. 12 to 17 hours hours
Read from the label, which states: “The half-life of dabigatran in healthy adult subjects is 12 to 17 hours.”
How long effects linger.RNAWiki does not store this separately, and never works it out from another figure on this page.
Beyond the studies. Nothing is recorded about the long term.
The longest finished study sets the edge of what anyone measured.
A study window is not how long people took it, and neither is how long they were followed. Where RNAWiki holds only one of the three, it shows one.
What is missing or unclear◇Read from sources, not yet reviewed
Were people like you studied?
RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.
Who was studied
People similar to this profile were included.
Adults with atrial fibrillation that is not caused by a diseased or replaced heart valve, and adults treated for or at risk of venous clots. It is explicitly contraindicated in people with a mechanical heart valve, for the reason set out in the audit points below.
Who is missing from the studies
Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What the label states about particular groups
On pediatric, the label states: “Safety and effectiveness of dabigatran etexilate capsules have not been established in pediatric patients with non-valvular atrial fibrillation or those who have undergone hip replacement surgery.”
US prescribing information · d5937f27-88c7-4c4a-801e-4c8945008982 · read 2026-08-30
On older people, the label states: “Of the total number of patients in the RE-LY study, 82% were 65 and over, while 40% were 75 and over.”
US prescribing information · d5937f27-88c7-4c4a-801e-4c8945008982 · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary The limited available data on dabigatran etexilate capsules use in pregnant women are insufficient to determine drug-associated risks for adverse developmental outcomes.”
US prescribing information · d5937f27-88c7-4c4a-801e-4c8945008982 · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary There are insufficient data to assess the presence of dabigatran in human milk.”
US prescribing information · d5937f27-88c7-4c4a-801e-4c8945008982 · read 2026-08-30
On people with reduced kidney function, the label states: “Reduction of Risk of Stroke and Systemic Embolism in Non-valvular Atrial Fibrillation in Adult Patients No dose adjustment of dabigatran etexilate capsules is recommended in patients with mild or moderate renal impairment [see Clinical Pharmacology ( 12.3 )].”
US prescribing information · d5937f27-88c7-4c4a-801e-4c8945008982 · read 2026-08-30
Where the result stopped carrying
Major bleeding was not reduced at the approved 150 mg dose (3.11% vs 3.36% per year, p=0.31); only the weaker 110 mg dose reduced it
RE-ALIGN was terminated early for excess thromboembolic and bleeding events in mechanical heart valves, and mechanical valves are now a contraindication
The RE-LY dataset was corrected after publication when previously unidentified events were reported, and the myocardial infarction odds ratio moved with it
Ximelagatran, the earlier oral direct thrombin inhibitor from the same pharmacological idea, was withdrawn for hepatotoxicity before dabigatran reached the market
This is a scope explorer, not a diagnosis engine.
It shows who was studied so you can see whether people similar to you were included.
RNAWiki cannot tell whether a study fits you. It can show who was in it.
What it would be like to take◇Read from sources, not yet reviewed
Why it might seem to do nothing
A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.
It was studied for a different goal
The studies measured something else entirely.
On this record: Some registered studies measured things that match no goal on this page.
It was studied in different people
The people in the studies were not much like the reader.
On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
The evidence may simply be wrong
Small early studies often do not hold up.
On this record: RNAWiki has not yet published a reviewed conclusion for this use.
Other reasons RNAWiki checked and found nothing for (10)
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.
None of these is a reason to take more. Taking more is not a step this page ever suggests.
What it would be like to take◇Read from sources, not yet reviewed
What taking it involves
The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.
How it is supplied
Prescription only
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Read from the recorded approval status.
No source is stored against this line.
Form and route
Oral capsule containing acid-core pellets, taken twice daily
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form and route recorded on this substance.
No source is stored against this line.
Who oversees it
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Suppression classes recorded: S1.
No source is stored against this line.
What is in the pack
The capsule shell holds pellets whose cores are tartaric acid, because the drug dissolves only in an acidic microenvironment. Opening, chewing or crushing the capsule raises absorption substantially and is specifically warned against on the label. Bottles carry a use-by period after opening because the pellets are moisture-sensitive.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on how this is sold and what that means for what is in the pack.
No source is stored against this line.
Where it is registered
Regulatory records are listed in the technical disclosure at the foot of this page.
# Counted from records
Where this came from
A count of rows RNAWiki holds. It describes our records, not your body.
Register entries are stored per jurisdiction and shown with their dates.
No source is stored against this line.
Why people stop
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
No record of why people stopped taking it is stored for this substance.
No source is stored against this line.
What it would be like to take◇Read from sources, not yet reviewed
What can go wrong
Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.
·Worth asking a clinician aboutWritten into the record from the studies named on this page
The US label carries two boxed warnings: premature discontinuation increases the risk of thrombotic events, and spinal or epidural haematoma can occur in patients receiving neuraxial anaesthesia or spinal puncture. Approximately 80% of absorbed active drug is cleared by the kidneys, so renal impairment raises exposure and bleeding risk. Dyspepsia and gastritis-like symptoms are common and are the main reason people stop. Contraindicated with mechanical prosthetic heart valves. Idarucizumab is the specific reversal agent.
Nobody counted how many people took this and were fine, so this cannot be turned into a rate.
These are reports people sent to a regulator. They do not show the medicine caused the reaction.
Nobody counted how many people took the medicine and reported nothing.
The same event can be reported more than once, and many reports are incomplete.
News coverage, lawsuits and new warnings change how often people report.
A count is not a rate and not a risk.
Dabigatran etexilate appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 13452 reaction mentions were counted. One report can name several reactions.
open-targets-adr · recorded 2026-06-24 · a recorded source, not a stored snapshot
Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.
Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What is missing or unclear◇Read from sources, not yet reviewed
Does the exact form matter?
Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.
The form that was studied
Oral capsule containing acid-core pellets, taken twice daily
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form used in the studies cited on this page.
No source is stored against this line.
What is sold
Opening, chewing or crushing the capsule raises absorption substantially and is specifically warned against on the label. Bottles carry a use-by period after opening because the pellets are moisture-sensitive.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on which forms are sold and how they compare.
No source is stored against this line.
What is recorded as being sold
74 products list this as an active ingredient in the United States drug directory. 74 of them contain it and nothing else.
FDA National Drug Code directory · 72205-202 · read 2026-08-29
They are sold as capsule, capsule, coated pellets, pellet and powder, taken oral.
FDA National Drug Code directory · 72205-202 · read 2026-08-29
The regulator's established pharmacologic class for it is direct thrombin inhibitor [epc] and thrombin inhibitors [moa].
FDA National Drug Code directory · 72205-202 · read 2026-08-29
21 published labels name it as an active ingredient. 21 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · d5937f27-88c7-4c4a-801e-4c8945008982 · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · d5937f27-88c7-4c4a-801e-4c8945008982 · read 2026-08-29
Dabigatran Etexilate is oral at 3 DOSAGE FORMS AND STRENGTHS 150 mg capsules with a cream opaque cap/cream opaque body size ‘0’ HPMC capsules imprinted with ‘H’ on cap and ‘D11’ on body with black ink, filled with mixture of off-white to yellowish whi…, recorded as fda label in effect 2025-12-03 in the United States.
US prescribing information · d5937f27-88c7-4c4a-801e-4c8945008982 · read 2026-08-30
Recorded price in US: 0.82255–0.94602 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 42 priced products whose strengths and pack forms differ, as of 2026-08-26, paid by retail pharmacies buying the product, as surveyed by the Centers for Medicare & Medicaid Services. It is not a list price, an insurance price, or what anyone pays at a counter..
Recorded source · 2026-08-26 · read 2026-08-28
Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.
What it would be like to take◇Read from sources, not yet reviewed
What you could measure
This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.
Self-experiment planning is not offered for a prescription or clinician-supervised medicine. The questions below are for a clinician or pharmacist.
Questions worth asking
Which of the trials of Dabigatran etexilate studied people like me?
What was measured, and for how long?
Was the result a laboratory value or a health outcome?
What would we watch for, and when would we stop?
Tracking can show whether something changed for you. It cannot show what caused it.
RNAWiki records evidence. It does not say whether this substance is right for you.
What is missing or unclear◇Read from sources, not yet reviewed
Claims that go past the evidence
Things said about this substance that sound reasonable, and the exact step that is missing between the evidence and the claim.
✗Goes past the evidence
That dabigatran reduces mortality — the RE-LY mortality difference reached p=0.051 at 150 mg and p=0.13 at 110 mg, and neither crossed significance
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That fixed dosing without plasma-level measurement is optimal — a convenience claim whose supporting analyses were reported by the BMJ as undisclosed
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That dabigatran is better or worse than apixaban or rivaroxaban — no randomised head-to-head trial exists between any pair of the direct oral anticoagulants
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That reversing the coagulation assay with idarucizumab improves survival — RE-VERSE AD was single-arm and measured a laboratory parameter
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
What is missing or unclear◇Read from sources, not yet reviewed
What nobody knows yet
Open questions, each with why it is open and what would close it.
Missing populations
Which groups were under-represented in the studies has not been recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing long-term data
No completed tested study window is recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
No reviewed conclusion
RNAWiki has not yet published a reviewed conclusion for this use.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing interaction studies
No interaction was found in the registers checked. Not finding one is not the same as showing there is none.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Formulation uncertainty
Several salts, forms or products of Dabigatran etexilate are recorded. Results from one form may not transfer to another.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Mechanism not reviewed
No reviewed mechanism story exists for this substance.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
What happened in people◇Read from sources, not yet reviewed
Check any of this yourself
Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.
Every line above can be traced to the study named beside it. Follow the link and read it.
RE-LY: stroke or systemic embolism cut from 1.69% to 1.11% a year at the 150 mg dose
In plain words
In 18,113 people with atrial fibrillation, the higher dose prevented about a third of the strokes and travelling clots that warfarin allowed. That is a superiority result, not a tie.
What was measured
Annualised rate of stroke or systemic embolism over a median of 2.0 years
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
RE-LY (NCT00262600) randomised 18,113 patients with atrial fibrillation and a stroke risk factor to blinded dabigatran 110 mg or 150 mg twice daily, or unblinded adjusted-dose warfarin, with median follow-up of 2.0 years. The primary outcome of stroke or systemic embolism occurred at 1.69% per year on warfarin, 1.53% per year on dabigatran 110 mg (relative risk 0.91, 95% CI 0.74 to 1.11, p<0.001 for non-inferiority) and 1.11% per year on dabigatran 150 mg (relative risk 0.66, 95% CI 0.53 to 0.82, p<0.001 for superiority). All-cause mortality was 4.13% per year on warfarin against 3.75% (110 mg, p=0.13) and 3.64% (150 mg, p=0.051) — a mortality signal that did not reach significance at either dose.
Written into the record, not signed off as a reviewed claim
Haemorrhagic stroke fell by roughly three quarters — the most robust finding in the trial
In plain words
Bleeding into the brain, the most feared complication of any blood thinner, was about a quarter as common on dabigatran as on warfarin, at both doses tested.
What was measured
Annualised haemorrhagic stroke rate in RE-LY and intracranial haemorrhage hazard ratio in Medicare
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
In RE-LY, haemorrhagic stroke occurred at 0.38% per year on warfarin against 0.12% per year on dabigatran 110 mg (p<0.001) and 0.10% per year on dabigatran 150 mg (p<0.001). The FDA’s own observational study in 134,414 Medicare beneficiaries, published in Circulation in 2015 with 37,587 person-years of follow-up, reproduced the direction and the magnitude in routine practice: intracranial haemorrhage hazard ratio 0.34 (95% CI 0.26 to 0.46) against warfarin, alongside ischaemic stroke 0.80 (0.67 to 0.96) and death 0.86 (0.77 to 0.96). Two designs, a randomised trial and a propensity-matched cohort of very different patients, agreeing on the same effect.
Written into the record, not signed off as a reviewed claim
At the approved 150 mg dose, overall major bleeding was not reduced at all
In plain words
The dose that prevented the most strokes did not cause less bleeding overall than warfarin. It moved bleeding from the brain to the gut, and the gut bleeding got worse.
What was measured
Annualised major bleeding rate at 150 mg twice daily, and gastrointestinal bleeding hazard ratio in routine care
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
Major bleeding in RE-LY was 3.36% per year on warfarin against 2.71% per year on dabigatran 110 mg (p=0.003) and 3.11% per year on dabigatran 150 mg (p=0.31). Only the lower dose, which did not demonstrate superiority for stroke prevention, reduced major bleeding. The FDA Medicare cohort quantified where the bleeding went: major gastrointestinal bleeding hazard ratio 1.28 (95% CI 1.14 to 1.44) against warfarin, with the effect most pronounced at 150 mg twice daily. The trade is real and it is a trade — intracranial bleeding down by about two thirds, gastrointestinal bleeding up by about a quarter — and a page reporting only the first half is reporting half a trial.
Written into the record, not signed off as a reviewed claim
RE-ALIGN was stopped early: worse clotting and worse bleeding in mechanical valves
In plain words
A trial testing this drug in people with artificial heart valves was halted because they were having both more strokes and more bleeding than the people on warfarin. It is now a contraindication on the label.
What was measured
Stroke and major bleeding rates in mechanical valve recipients before early termination
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
RE-ALIGN (NCT01452347) randomised 252 patients with mechanical aortic or mitral valve replacement 2:1 to dabigatran or warfarin, with dabigatran doses selected by renal function and adjusted to a trough plasma level of at least 50 ng/mL. The trial was terminated prematurely for an excess of both thromboembolic and bleeding events. Ischaemic or unspecified stroke occurred in 9 dabigatran patients (5%) and no warfarin patients; major bleeding in 7 (4%) and 2 (2%), and every major bleed was pericardial. Dose adjustment or discontinuation was required in 52 of 162 dabigatran patients (32%) despite the protocol targeting a plasma level. This is a clean negative result, and it is also the clearest demonstration that "works in atrial fibrillation" does not transfer to "works against a mechanical valve" — different surfaces, different clotting pathway, different drug required.
Written into the record, not signed off as a reviewed claim
The trial result was revised after publication, when unreported events were found
In plain words
A year after RE-LY was published, the sponsor reported additional events that had not been counted the first time. The numbers everybody had already quoted changed.
What was measured
That the myocardial infarction excess reported from the original RE-LY dataset is a settled drug effect — it shrank on revision and did not reproduce in a 134,414-patient cohort
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
In November 2010 the RE-LY investigators published a letter in the New England Journal of Medicine, "Newly identified events in the RE-LY trial", reporting events found after the primary publication and giving revised rates. The revision matters most for the myocardial infarction question: Uchino and Hernandez pooled seven randomised trials of dabigatran totalling 30,514 patients and found myocardial infarction or acute coronary syndrome in 237 of 20,000 dabigatran patients (1.19%) against 83 of 10,514 controls (0.79%), odds ratio 1.33 (95% CI 1.03 to 1.71, p=0.03); using the revised RE-LY figures the same analysis gave 1.27 (1.00 to 1.61, p=0.05). The FDA Medicare cohort later found no myocardial infarction excess in routine practice (hazard ratio 0.92, 95% CI 0.78 to 1.08). So the field moved from "clear signal" to "small signal that may be chance", and the point of this entry is that the primary publication was not the final word on its own arithmetic.
Written into the record, not signed off as a reviewed claim
"No monitoring required" was a marketing property, not a measured one
In plain words
This drug was sold on not needing blood tests. Two BMJ investigations in 2014 reported that analyses linking blood levels to bleeding risk had not been disclosed.
What was measured
That fixed dosing without plasma-level measurement is the optimal use of dabigatran — an operating convenience presented as an established equivalence, with the analyses that bear on it undisclosed at the time of licensing
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Dabigatran was licensed with a fixed dose and no routine coagulation monitoring, which was the principal practical advantage claimed over warfarin. In July 2014 the BMJ published two linked investigations, "Dabigatran: how the drug company withheld important analyses" and "Concerns over data in key dabigatran trial", reporting that internal analyses of the relationship between plasma concentration and bleeding risk had not been made available to regulators. The pharmacology is not in dispute: dabigatran plasma concentration varies severalfold between patients, it is a P-glycoprotein substrate, and roughly 80% of the absorbed active drug is cleared by the kidneys, so renal function directly sets exposure. Assays that read it — the dilute thrombin time and the ecarin clotting time — existed throughout. Whether fixed dosing without them was optimal is a question the published trial was never designed to answer.
Written into the record, not signed off as a reviewed claim
Idarucizumab reverses it completely, which none of the factor Xa inhibitors could claim in 2015
In plain words
An antibody fragment made specifically for this drug switches it off within minutes. In 503 patients with serious bleeding or facing emergency surgery, the median reversal was total.
What was measured
Maximum percentage reversal of anticoagulant effect within four hours, by dilute thrombin time or ecarin clotting time
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
RE-VERSE AD (NCT02104947) enrolled 503 patients taking dabigatran: 301 with uncontrolled bleeding (group A, of whom 137 had gastrointestinal bleeding and 98 intracranial haemorrhage) and 202 needing an urgent procedure (group B). The median maximum reversal of anticoagulant effect within four hours of 5 g intravenous idarucizumab was 100% (95% CI 100 to 100) by dilute thrombin time or ecarin clotting time. Median time to cessation of bleeding, where assessable, was 2.5 hours; median time to the intended procedure was 1.6 hours with periprocedural haemostasis normal in 93.4%. At 90 days thrombotic events had occurred in 6.3% and 7.4% and mortality was 18.8% and 18.9% — those last figures reflect how sick this population is, not a drug effect, because the study was single-arm with no control.
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What is not here
3 questions this page could not answer
These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.
What it may clash with — found nothing in the sources checked.
Other ways to the same goal — found nothing in the sources checked.
What changed on this page — found nothing in the sources checked.
The record as stored
The full record, for auditing
Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.
The older medicine-wide conclusion held in this record
Written for a clinical reader, and about the medicine as a whole rather than about one indication, population and set of trials. RNAWiki does not treat it as a programme conclusion and no reviewer has signed it off in that form. It is here word for word because it is what the record holds.
A reversible thrombin blocker taken by mouth without blood-level monitoring, which cut stroke or systemic embolism from 1.69% to 1.11% a year against warfarin in 18,113 patients — while leaving overall major bleeding unchanged at that dose, and while its trial was corrected after publication when previously unreported events were found.
Recorded evidence blocks (13)
Q2
What did Dabigatran etexilate's largest trial (2140403 people) and its longest (12 years) measure?
2140403 people in Dabigatran etexilate's largest registered study, 12 years in its longest registered window, measuring Yearly Event Rate for Composite Endpoint of Stroke, Transient Ischaemic Attacks, System Thromboembolism, Myocardial Infarction, Other Major Adverse Cardiac Events and Mortality. ClinicalTrials.gov · 2026-09-01
79 phase1, 55 na or unstated, 38 phase4, 27 phase3, 20 phase2, 13 na, 2 early phase1; NCT03642509; 2030-10-01. Last human test completed 2026, NCT04618913.
Interpretation These counts include studies where Dabigatran etexilate was a comparison treatment, a background treatment or an exposure in an observational study, and the longest window may be a planned end date. Trial roles have not yet been classified for this record.
Show the evidence
phase1
79
na or unstated
55
phase4
38
phase3
27
phase2
20
na
13
2 more recorded rows
early phase1
2
Last recorded human testNCT04618913
2026-06-22
recorded 2026-09-01 · last checked 2026-09-04
Q3
Dabigatran etexilate was tested only in human — what did it show?
Interpretation Yearly Event Rate for Composite Endpoint of Stroke, Transient Ischaemic Attacks, System Thromboembolism, Myocardial Infarction, Other Major Adverse Cardiac… — the recorded outcome words.
Show the evidence
humanNCT00157248
lifespan; Yearly Event Rate for Composite Endpoint of Stroke, Transient Ischaemic Attacks, System Thromboembolism, Myocardial Infarction, Other Major Adverse Cardiac Events and Mortality.; 232
recorded 2026-09-01 · last checked 2026-09-04
Q4
17 of Dabigatran etexilate's trials stopped: safety, futility/efficacy, accrual/recruitment, other?
safety (1), futility/efficacy (1), accrual/recruitment (7) and other (8): Dabigatran etexilate's stop wording, clustered. ClinicalTrials.gov · 2026-09-01
"This trial was prematurely discontinued due to low enrolment."; 17 of 232 registered studies
Show the evidence
Trial
NCT01153698
terminated; "This trial was prematurely discontinued due to low enrolment."
NCT01352702
terminated; "Slow recruitment; Study was terminated for futility reasons"
NCT01546883
terminated; "Not enough patients in time period allotted for study"
NCT01810237
withdrawn; "No patients recruited"
NCT01868243
terminated; "because a significant decrease of viable candidates for the study."
NCT02256683
terminated; "Recruiting problems"
11 further recorded trials
NCT02596555
terminated; "1. Interim results suggested a reduction of sample size. 2. Anticipated length of enrolment period with resulting funding issues to pose a threat to the study."
NCT02872649
terminated; "safety reasons"
NCT03465735
terminated; "Due to lack of recruitment of eligible participants"
NCT03715725
terminated; "After feasibility assessment and due to delays in data receipt study was terminated"
NCT03752294
withdrawn; "Investigator left institution"
NCT03807856
terminated; "Difficult recruitment"
NCT04002011
withdrawn; "Submission process abandoned. No patient enrolled."
NCT04808934
withdrawn; "Withdrawn due to COVID19 pandemic. Several delays affected this study, therefore company decided to not conduct the study. It was cancelled prior to any enrollment."
NCT05536791
withdrawn; "No patients were screened in the study."
NCT05788328
terminated; "The decision to terminate clinical development of lotiglipron is based on pharmacokinetic data from Phase 1 drug-drug-interaction studies and laboratory measurements of elevated transaminases in these Phase 1 studies as well as a Phase 2…"
NCT07515339
withdrawn; "The study is no longer required."
recorded 2026-09-01 · last checked 2026-09-04
Q5
Human studies of Dabigatran etexilate used dabigatran etexilate 150 mg — over how long?
15 recorded entries; human; oral; also "dabigatran etexilate 150 mg", "dabigatran 110 mg", "Dabigatran (Pradaxa)75 mg"
Show the evidence
human
NCT00291330
dabigatran etexilate 150 mg
NCT00818753
dabigatran 110 mg
NCT01385683
Dabigatran (Pradaxa)75 mg
NCT01385683
Dabigatran (Pradaxa) 75 mg
NCT01590823
Dabigatran Etexilate 110 mg
NCT01590823
Dabigatran Etexilate 110 mg (Pradax)
9 more recorded rows
humanNCT01868243
Pradaxa® (dabigatran etexilate) 110mg twice daily
humanNCT01994265
Dabigatran 150 mg twice daily
humanNCT02149303
Dabigatran 150 mg
humanNCT02164864
Dabigatran Etexilate 110mg
humanNCT02164864
Dabigatran Etexilate 150mg
humanNCT03495739
Dabigatran Etexilate Mesylate 150 MG Oral Capsule
humanNCT05492318
oral; Dabigatran etexilate 75 mg oral hard capsules
humanNCT06441916
Dabigatran Etexilate Capsules 150 mg
humanNCT06876623
dabigatran etexilate mesylate capsules 150mg
recorded 2026-09-01 · last checked 2026-09-04
Q6
Dabigatran etexilate's half-life is 12 to 17 hours — which schedules were studied?
12 to 17 hours, the half-life Dabigatran etexilate's label states. openfda-label · 3a8ec82a-c367-40dc-9302-e1896fcb05ea · 2026-08-30
bioavailability 75% %.
Show the evidence
half life
12 to 17 hours hours; The half-life of dabigatran in healthy adult subjects is 12 to 17 hours.
bioavailability
75% %; The oral bioavailability of dabigatran etexilate increases by 75% when the pellets are taken without the capsule shell compared to the intact capsule formulation based on a single-dose relative bioavailability study.
metabolism
Metabolism After oral administration, dabigatran etexilate is converted to dabigatran.
recorded 2026-08-30 · last checked 2026-09-04
Q7
Which of adp induced platelet aggregation, adverse events and auctau ss did Dabigatran etexilate's trials measure?
adp induced platelet aggregation, adverse events and auctau ss lead 40 outcome terms across Dabigatran etexilate's trials. ClinicalTrials.gov · 2026-09-01
Interpretation adverse events, plasma concentration of free dabigatran, plasma concentration of total dabigatran, cmax, tmax and frequency of major bleeding event follow.
Show the evidence
composite of recurrent vte or vte death at 36 months
1
composite of recurrent vte or vte death at 18 months
1
bleeding events
1
adverse events
1
plasma concentration of free dabigatran
1
plasma concentration of total dabigatran
1
14 more recorded rows
cmax
1
tmax
1
frequency of major bleeding event
1
frequency of clinically relevant bleeding event
1
frequency of nuisance bleeding event
1
incidence and severity of adverse events
1
discontinuation of the study drug due to adverse events
1
changes in laboratory test values
1
vitro reversal of anticoagulation
1
venous thromboembolic events
1
major bleeding events
1
total dabigatran area under the curve 0 to infinity
1
adp induced platelet aggregation
1
microbleeds on mri
1
recorded 2026-09-01 · last checked 2026-09-04
Q8
Which of Dabigatran etexilate's 22 ongoing trials reports first?
Primary efficacy outcome: A composite endpoint of stroke, myocardial infarction, thromboembolic event or all-cause death.; Primary efficacy outcome: a composite endpoint of new venous thromboembolism or all-cause death.; latest 2031-04-21
Show the evidence
Trial
NCT03129490
"The Danish Non-vitamin K Antagonist Oral Anticoagulation Study in Patients With Atrial Fibrillation"; n 11000; "Primary efficacy outcome: A composite endpoint of stroke, myocardial infarction, thromboembolic event or all-cause death."; 2027-10-30
NCT03129555
"The Danish Non-vitamin K Antagonist Oral Anticoagulation Study in Patients With Venous Thromboembolism (DANNOAC-VTE)"; n 5000; "Primary efficacy outcome: a composite endpoint of new venous thromboembolism or all-cause death."; 2029-03-31
NCT03642509
"Left Atrial Appendage Occlusion Versus Novel Oral Anticoagulation for Stroke Prevention in Atrial Fibrillation"; n 750; "Composite endpoint of stroke (ischemic and hemorrhagic), systemic embolism, major bleeding and all-cause mortality."; 2030-10-01
NCT03968393
"Anticoagulation for Stroke Prevention In Patients With Recent Episodes of Atrial Fibrillation Occurring Transiently With Stress"; n 2270; "Incidence of Non-hemorrhagic stroke or systemic embolism"; 2028-12
NCT04045093
"Dabigatran for Mitral Stenosis Atrial Fibrillation"; n 370; "Composite of stroke, systemic embolism, myocardial infarction, and death from cardiovascular or unknown cause."; 2027-09-30
NCT04262492
"International Registry of Thrombotic APS Patients Treated With Direct Oral Anticoagulants"; n 500; "Rate of Recurrent Thrombosis"; 2031-04-21
14 further recorded trials
NCT04284839
"The Direct Oral Anticoagulation Versus Vitamin K Antagonist After Cardiac Surgery Trial"; n 3500; "Major Bleeding"; 2027-06
NCT04695106
"Dual Antithrombotic Therapy With Dabigatran and Ticagrelor in Patients With ACS and Non-valvular AF Undergoing PCI"; n 1194; "Primary safety endpoint - first major or clinically relevant non-major bleeding event, as defined by the ISTH"; 2026-08-31
NCT04847752
"Study of Predictive Factors Related to Prognosis of Patients With Ischemic Stroke Due to Large-artery Atherosclerosis"; n 1000; "all-cause mortality"; 2028-12-31
NCT05735639
"THRomboprophylaxis in Individuals Undergoing Superficial endoVEnous Treatment (THRIVE)"; n 3175; "Imaging confirmed lower limb deep vein thrombosis (DVT) with or without symptoms, or pulmonary embolism (PE) with symptoms within 90 days of varicose vein treatment."; 2027-12-31
NCT06449469
"The Nordic Aortic Valve Intervention Trial 4 (NOTION-4)"; n 352; "HALT after 1 year"; 2030-04-01
NCT06486792
"Stroke Prevention In Ischemic Stroke With Covert Atrial Fibrillation"; n 1148; "Occurrence of fatal or nonfatal ischemic stroke, or peripheral emboli (even if asymptomatic) [peripheral emboli: emboli in arm or leg, new renal, splenic, hepatic, mesenteric infarction]"; 2028-12-18
NCT06551402
"Dabigatran Versus Rivaroxaban in Cerebral Venous Thrombosis"; n 200; "The proportion of subjects who have partial or complete venous recanalization by Day 180"; 2026-11-01
NCT06650501
"Dabigatran vs. Oral Anti-Xa Inhibitors in S. Aureus Bacteremia"; n 300; "Desirability of Outcome Ranking (DOOR)"; 2030-01
NCT06818279
"Compare the Efficacy and Safety of Dabigatran and Enoxaparin in Patients With Portal Vein Thrombosis With Cirrhosis"; n 120; "Proportion of patients achiving recanalization of Portal Vein Thrombosis (PVT) in cirrhosis patients at 6-months in both groups."; 2026-01-31
NCT07011095
"DOAC or VKA in Patients With AF and Stroke While on DOAC - a Pilot Trial"; n 100; "Feasibility - Recruitment"; 2027-06-03
NCT07083609
"Treatment Outcomes of Direct Oral Anticoagulants in Cerebral Venous Thrombosis in Vietnam"; n 69; "Composite of major bleeding or recurrent venous thromboembolism"; 2027-12
NCT07190430
"A Study to Learn If the Study Medicine Called PF-08049820 Changes How the Body Processes the Other Study Medicines Called Oral Contraceptives, Midazolam, and Dabigatran in Healthy Adult Female Participants"; n 16; "Pharmacokinetics (PK): Area Under the curve (AUC) of Midazolam"; 2025-12-15
NCT07358416
"Complications and Antiplatelet and Anticoagulant Therapy in Vascular Surgery."; n 500; "Bleeding"; 2026-02-28
NCT07629999
"Single and Multiple Dose Study to Evaluate Safety and Pharmacokinetics of BMS-986533 in Healthy Participants and Assessments of Food and pH Effects on Relative Bioavailability, and Drug-Drug Interaction Potential in Healthy Participants"; n 136; "Number of participants with Adverse Events (AE)"; 2027-06-01
recorded 2026-09-01 · last checked 2026-09-04
Q9
Which running trial of Dabigatran etexilate could settle lifespan?
NCT04847752 measures all-cause mortality, reading out 2028-12-31.
2 open trials; n 1000; "Study of Predictive Factors Related to Prognosis of Patients With Ischemic Stroke Due to Large-artery Atherosclerosis"
Show the evidence
Trial
NCT04847752
"Study of Predictive Factors Related to Prognosis of Patients With Ischemic Stroke Due to Large-artery Atherosclerosis"; n 1000; "all-cause mortality"; 2028-12-31
NCT03642509
"Left Atrial Appendage Occlusion Versus Novel Oral Anticoagulation for Stroke Prevention in Atrial Fibrillation"; n 750; "Composite endpoint of stroke (ischemic and hemorrhagic), systemic embolism, major bleeding and all-cause mortality."; 2030-10-01
Q10
Which 58 trials of Dabigatran etexilate posted no result?
Posted no result
58 of 58 completed trials
Registrations
NCT01210755, NCT01379300, NCT01385683, NCT01339819, NCT01590823 and NCT02102633, and 52 more
Completion dates
oldest 2011-06; newest 2024-06-15
Show the evidence
Trial
NCT01210755
2011-06
NCT01379300
2011-12
NCT01385683
2011-12
NCT01339819
2012-09
NCT01590823
2012-09
NCT02102633
2014-06
14 further recorded trials
NCT02792335
2014-08
NCT01431456
2014-10
NCT01593150
2015-02
NCT02833987
2015-03
NCT02389582
2015-11
NCT02524210
2015-12
NCT02769078
2016-02
NCT02687867
2016-03-01
NCT01911624
2016-07
NCT02607371
2016-10-15
NCT03568916
2016-11
NCT02945020
2017-01-20
NCT03189069
2017-05-31
NCT02361619
2017-06
Q11
At the median, Dabigatran etexilate's trials enrolled 98 people — anything larger?
Median enrolment
98
Largest enrolment
2140403
Registered trials counted
232
Q12
What do 13452 spontaneous reports say about Dabigatran etexilate — and not say?
These are reports people sent to a regulator. They do not show the medicine caused the reaction. Nobody counted how many people took the medicine and reported nothing. The same event can be reported more than once, and many reports are incomplete. News coverage, lawsuits and new warnings change how often people report. A count is not a rate and not a risk.
Dabigatran etexilate appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 13452 reaction mentions were counted: gastrointestinal haemorrhage 3252; cerebrovascular accident 2439; ischaemic stroke 1809; haemorrhage 1252. open-targets-adr · CHEMBL1615369 · 2026-06-24
Show the evidence
gastrointestinal haemorrhage
3252
cerebrovascular accident
2439
ischaemic stroke
1809
haemorrhage
1252
rectal haemorrhage
957
melaena
879
4 more recorded rows
deep vein thrombosis
792
pulmonary embolism
751
procoagulant therapy
675
transient ischaemic attack
646
recorded 2026-06-24 · last checked 2026-09-04
Q13
Dabigatran etexilate and P-GP, CYP2C9 and CYP3A4: shared by which compounds?
P-GP, CYP2C9 and CYP3A4 appear in Dabigatran etexilate's recorded interaction sentences, 2 in all. openfda-label+europepmc · 2026-08-30
Interpretation pharmacokinetics
Show the evidence
CYP2C9pharmacokinetics
Impact of Dabigatran on Other Drugs In clinical studies exploring CYP3A4, CYP2C9, P-gp and other pathways, dabigatran did not meaningfully alter the pharmacokinetics of amiodarone, atorvastatin, clarithromycin, diclofenac, clopidogrel, digoxin, pantoprazole, or ranitidine. dabigartanfigure31 dabigartanfigure32
CYP3A4pharmacokinetics
Impact of Dabigatran on Other Drugs In clinical studies exploring CYP3A4, CYP2C9, P-gp and other pathways, dabigatran did not meaningfully alter the pharmacokinetics of amiodarone, atorvastatin, clarithromycin, diclofenac, clopidogrel, digoxin, pantoprazole, or ranitidine. dabigartanfigure31 dabigartanfigure32
recorded 2026-08-30 · last checked 2026-09-04
Q14
Was Dabigatran etexilate studied with fasting?
fasting is named in Dabigatran etexilate's label sentences: "Fifty healthy subjects were recruited for each of the fasting and postprandial trials in a randomized, two-sequence, open-label, four-cycle, fully replicated trial design of a single 150 mg dose of either the test or the reference formulation of dabigatran etexilate capsules in the fasting and…" openfda-label+europepmc · 2026-08-30
1 recorded statement; fasting
Show the evidence
fasting
Fifty healthy subjects were recruited for each of the fasting and postprandial trials in a randomized, two-sequence, open-label, four-cycle, fully replicated trial design of a single 150 mg dose of either the test or the reference formulation of dabigatran etexilate capsules in the fasting and postprandial states.
recorded 2026-08-30 · last checked 2026-09-04
Where it is registeredIdentifiers, relations and other names
ClinicalTrials.gov — US Government work · Europe PMC — metadata only, under the recorded legal gate · Open Targets 26.06 — CC0 · derived from this page's own recorded fields; no external licence · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work
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