This page shows what was measured, who it was measured in, and what that does not settle.
What Argatroban Anhydrous does in the body
Argatroban is a small molecule that sits directly in thrombin’s cutting site and blocks it, without needing any helper protein.
Thrombin is the enzyme at the end of the clotting chain: it cuts a soluble blood protein into the fibrin threads that hold a clot together, and it also switches platelets on. Because it is small it can reach thrombin that is already buried inside an existing clot, which heparin cannot do. It is broken down by the liver rather than the kidneys, and it wears off within about an hour of stopping the drip.
Why people take it. Preventing or treating clots after a dangerous immune reaction to heparin.
What happened in people
Compared with earlier patient records, it reduced new clots but did not reduce death or amputation.
✓ Reviewed first-read answer
Where this came from
A person wrote this and a reviewer approved it against this exact record. It carries no effect size.
A reviewer approved this against this record. The reviewed-claim record carrying the exact population and effect size does not exist yet.
No source is stored against this line.
The limit that matters most
Its approval comparisons used earlier patient records rather than assigning current patients by chance.
Where it acts
Blood plasma and the surface of a forming clot — argatroban reaches thrombin already trapped inside a clot, which heparin cannot
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 · IY90U61Z3S · read 2026-08-29
Where each sentence above came from
A person wrote this explanation into the record, with the studies named in the path below.
A reviewer approved this sentence against this exact record and its sources.
The limit a reviewer approved as the one that matters most here.
The four opening statements run to 122 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.
Comparator
A comparator is whatever the treatment was measured against.
A picture of it, and where the picture fails
It is like the other runner in a race.
Where that stops being true. A race has one winner. A study can show both arms improved.
What people get wrong. Results are read without asking what the other group got. Beating nothing is not beating a treatment.
The control condition against which the experimental intervention is assessed.
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 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.
Composite of all-cause death, all-cause amputation or new thrombosis over 37 days, argatroban versus 193 historical control subjects
Isolated thrombocytopenia 25.6% vs 38.8%, p=0.014. Thrombocytopenia with thrombosis 43.8% vs 56.5%, p=0.13 — not significant
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. No randomisation, no concurrent control and no blinding. The historical cohort was treated in an earlier era of intensive care and of heparin-induced thrombocytopenia diagnosis, which cannot be separated from any drug effect.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Continuous intravenous infusion, hospital use only
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
Isolated thrombocytopenia 28.0% vs 38.8%, p=0.04. Thrombocytopenia with thrombosis 41.5% vs 56.5%, p=0.07 — not significant
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. The publication states there were no significant between-group differences in all-cause death or amputation. The composite moved on new thrombosis alone. Historical control again.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Continuous intravenous infusion, hospital use only
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
Subjective assessment of satisfactory procedural outcome and of adequate anticoagulation during percutaneous coronary intervention
✓ The study showed what it set out to show
Who was studied
Argatroban during percutaneous coronary intervention in heparin-induced thrombocytopenia
How many people
91
Study design
Single-arm open-label study, 112 procedures in 91 patients
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
94.5% satisfactory procedural outcome, 97.8% adequate anticoagulation. No control group, therefore no comparative statistic
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. Death, myocardial infarction or revascularisation at 24 hours in 7.7%, periprocedural major bleeding in 1.1%. The comparison to heparin was to figures "historically reported", not to a randomised arm.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Continuous intravenous infusion, hospital use only
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
Utility-weighted 90-day modified Rankin scale score after intravenous thrombolysis for acute ischaemic stroke, argatroban or eptifibatide versus placebo
✗ The study did not show it
Who was studied
MOST (NCT03735979)
How many people
514
Study design
Phase 3 adaptive single-blind randomised placebo-controlled trial, three groups
Compared against
A dummy treatment
Kind of result
A number that stands in for health
What was found
Argatroban 5.2±3.7 vs placebo 6.8±3.0 (higher is better). Posterior probability argatroban better than placebo 0.002; posterior mean difference -1.51±0.51
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. 90-day mortality 24% with argatroban against 8% with placebo, without a corresponding excess of symptomatic intracranial haemorrhage (4% vs 2%). Only 59 patients were assigned to argatroban.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Continuous intravenous infusion, hospital use only
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
63.8% (210/329) vs 64.9% (238/367), risk difference -1.0% (95% CI -8.1% to 6.1%), risk ratio 0.98 (0.88 to 1.10), p=0.78
Repeated elsewhere
Replicated
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. No safety signal: symptomatic intracranial haemorrhage 2.1% vs 1.8%, major systemic bleeding 0.3% vs 0.5%. Open-label treatment with blinded endpoint assessment, conducted entirely in China.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Continuous intravenous infusion, hospital use only
Interval reported. 95% CI -8
Written into the record, not signed off as a reviewed claim.
RNAWiki holds 5 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 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
Argatroban Anhydrous
What a person takes: Continuous intravenous infusion, hospital use only.
The measurement behind this step
Given as a continuous infusion, either from a 100 mg/mL concentrate diluted a hundredfold in sodium chloride, dextrose or lactated Ringer’s solution, or from a ready-to-use 1 mg/mL premixed bag. Steady state is reached in 1 to 3 hours and monitored by the activated partial thromboplastin time in heparin-induced thrombocytopenia, or by the activated clotting time during coronary intervention. The existence of two presentations differing hundredfold in concentration is itself a recognised medication-safety hazard.
Getting in
A continuous drip, because it wears off in under an hour
Given only as a constant infusion in hospital. Stop the drip and the effect is largely gone within an hour, which is the closest thing to an antidote this drug has.
──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
Steady-state plasma concentration and anticoagulant effect are reached within 1 to 3 hours of starting the infusion, with low intersubject variability, and the elimination half-life is 39 to 51 minutes. There is no reversal agent; discontinuation is the reversal strategy. Supplied both as a 100 mg/mL concentrate requiring hundredfold dilution and as a ready-to-use 1 mg/mL solution.
Heparin only works by grabbing a natural blood protein and speeding it up. Argatroban needs no such helper — it attacks the enzyme itself.
──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
Direct inhibition, with no requirement for antithrombin III. This matters in the sickest patients: antithrombin levels fall in sepsis, disseminated intravascular coagulation and after cardiopulmonary bypass, and a heparin in an antithrombin-depleted patient loses potency for a reason that has nothing to do with dose.
It sits in the pocket thrombin uses to grip its target
Thrombin recognises what to cut by a specific chemical group. Argatroban carries a copy of that group and jams the slot, without ever being cut itself.
╌╌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 guanidine of the arginine-derived core inserts into the S1 specificity pocket and forms a salt bridge with aspartate 189, mimicking the arginine of fibrinogen that thrombin normally cleaves. Binding is reversible and competitive, with an inhibition constant of 0.04 micromolar, and selective — little or no effect on trypsin, factor Xa, plasmin or kallikrein at therapeutic concentrations.
Small enough to get inside a clot that has already formed
Once a clot exists, thrombin sits trapped within it and keeps the clot growing. Heparin cannot reach that thrombin. This drug 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
Heparin acts through antithrombin, a 58 kDa serpin that cannot access thrombin bound to fibrin within a formed thrombus. Argatroban, at 508.6 daltons, inhibits clot-associated thrombin directly. Blocking thrombin also prevents activation of factors V, VIII and XIII, prevents activation of protein C, and blunts thrombin-mediated platelet aggregation — which is the specific thing that matters when a platelet-activating antibody is already circulating.
Fewer new clots, with death and amputation unchanged
Compared with earlier patients treated before the drug existed, fewer went on to develop new clots. Deaths and amputations were not significantly different.
╌╌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
ARG-911: composite of death, amputation or new thrombosis 25.6% against 38.8% in isolated thrombocytopenia (p=0.014), 43.8% against 56.5% with thrombosis (p=0.13). ARG-915: 28.0% against 38.8% (p=0.04) and 41.5% against 56.5% (p=0.07), with no significant difference in all-cause death or amputation. Platelet counts rose faster on argatroban in both studies and bleeding rates were similar. Both control groups were historical.
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 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.
Hospital inpatients who develop heparin-induced thrombocytopenia, and patients with that history who need a coronary procedure. Argatroban is given only as a continuous intravenous infusion, in hospital, under laboratory monitoring.
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 have not been established in pediatric patients.”
US prescribing information · e5ccb93c-f411-4e7e-824a-4a592b4947ec · read 2026-08-30
On older people, the label states: “Of the total number of subjects (1,340) in clinical studies of argatroban, 35% were 65 and over.”
US prescribing information · e5ccb93c-f411-4e7e-824a-4a592b4947ec · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary Limited data from published literature and postmarketing reports do not suggest an association between argatroban and adverse fetal outcomes.”
US prescribing information · e5ccb93c-f411-4e7e-824a-4a592b4947ec · read 2026-08-30
On people who are breastfeeding, the label states: “There are no data on the presence of argatroban in human milk, or its effects on milk production.”
US prescribing information · e5ccb93c-f411-4e7e-824a-4a592b4947ec · read 2026-08-30
On people with reduced liver function, the label states: “Dose reduction and careful titration are required when administering argatroban to patients with hepatic impairment.”
US prescribing information · e5ccb93c-f411-4e7e-824a-4a592b4947ec · read 2026-08-30
Where the result stopped carrying
The thrombocytopenia-with-thrombosis arm of both pivotal studies, p=0.13 and p=0.07
All-cause death and amputation, which did not differ from historical controls in the confirmatory study
MOST, where 90-day mortality was three times placebo and the posterior probability of benefit was 0.002
ARAIS, a flat null result in 817 randomised stroke patients
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 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 (11)
It was studied for a different goal
The studies measured something else entirely. Nothing in this record points to this reason.
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
Given by a clinician
❝ 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
Continuous intravenous infusion, hospital use only
✎ 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
Given as a continuous infusion, either from a 100 mg/mL concentrate diluted a hundredfold in sodium chloride, dextrose or lactated Ringer’s solution, or from a ready-to-use 1 mg/mL premixed bag.
✎ 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. The rest of the recorded wording: Steady state is reached in 1 to 3 hours and monitored by the activated partial thromboplastin time in heparin-induced thrombocytopenia, or by the activated clotting time during coronary intervention. The existence of two presentations differing hundredfold in concentration is itself a recognised medication-safety hazard.
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
Haemorrhage can occur at any site, and the label names intracranial and retroperitoneal haemorrhage specifically; an unexplained fall in haematocrit or blood pressure is the warning sign. Risk rises with severe hypertension, recent lumbar puncture or spinal anaesthesia, major surgery involving the brain, spinal cord or eye, congenital or acquired bleeding disorders, and gastrointestinal ulceration. Clearance is hepatic: a lower starting dose is required in moderate or severe hepatic impairment, and use during coronary intervention is to be avoided in clinically significant hepatic impairment. There is no reversal agent — the 39 to 51 minute half-life is the only exit. Argatroban prolongs the international normalised ratio independently of any vitamin K antagonist.
Nobody counted how many people took this and were fine, so this cannot be turned into a rate.
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
Continuous intravenous infusion, hospital use only
✎ 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
Steady state is reached in 1 to 3 hours and monitored by the activated partial thromboplastin time in heparin-induced thrombocytopenia, or by the activated clotting time during coronary intervention. The existence of two presentations differing hundredfold in concentration is itself a recognised medication-safety hazard.
✎ 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
25 products list this as an active ingredient in the United States drug directory. 25 of them contain it and nothing else.
FDA National Drug Code directory · 45562-1124 · read 2026-08-29
They are sold as injection, injection, solution, powder and solution, taken intravenous.
FDA National Drug Code directory · 45562-1124 · read 2026-08-29
The regulator's established pharmacologic class for it is anti-coagulant [epc], direct thrombin inhibitor [epc] and thrombin inhibitors [moa].
FDA National Drug Code directory · 45562-1124 · read 2026-08-29
17 published labels name it as an active ingredient. 17 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · e5ccb93c-f411-4e7e-824a-4a592b4947ec · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · e5ccb93c-f411-4e7e-824a-4a592b4947ec · read 2026-08-29
Argatroban is intravenous at 3 DOSAGE FORMS AND STRENGTHS Argatroban Injection is supplied in a single-dose vial containing 125 mg argatroban in 125 mL aqueous sodium chloride solution (1 mg/mL)., recorded as fda label in effect 2026-03-17 in the United States.
US prescribing information · e5ccb93c-f411-4e7e-824a-4a592b4947ec · read 2026-08-30
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 Argatroban Anhydrous 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 the difference from the historical control cohort is a drug effect — neither pivotal study randomised or blinded anyone
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 argatroban reduces death or amputation in heparin-induced thrombocytopenia — the composite moved on new thrombosis and the severe components did not
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 it performs comparably to heparin during coronary intervention — a single-arm study with subjective primary endpoints compared informally to historical heparin figures
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 inhibiting clot-bound thrombin translates into better clinical outcomes — a real mechanistic advantage that no trial in this population can ethically test
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 an international normalised ratio measured during an infusion reads vitamin K antagonist effect — argatroban prolongs the assay itself, variably by reagent
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.
How much did people take in the studies?
The sources RNAWiki checked hold nothing for this field.
Why it matters. A result belongs to an amount. Without the amount the result floats free.
What would answer it
A stored source that records 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 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 Argatroban Anhydrous 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.
Both pivotal trials compared the drug against a historical control cohort
In plain words
Neither trial randomised anyone. Patients given argatroban were compared with records of earlier patients treated before the drug existed, which is a much weaker design than a coin toss.
What was measured
Composite of all-cause death, all-cause amputation or new thrombosis over 37 days, against a historical control cohort
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
ARG-911 was a prospective, historical-controlled study in which 304 patients — 160 with isolated thrombocytopenia and 144 with thrombocytopenia and thrombosis — received argatroban at 2 micrograms per kilogram per minute adjusted to an activated partial thromboplastin time 1.5 to 3.0 times baseline, for a mean of six days. Their outcomes over 37 days were compared with 193 historical control subjects. The composite of all-cause death, all-cause amputation or new thrombosis was 25.6% against 38.8% in the isolated thrombocytopenia group (p=0.014). In the thrombosis group it was 43.8% against 56.5% (p=0.13) — not significant. This is the trial the approval rests on, and its control group was assembled from records rather than randomised. A historical comparison cannot separate a drug effect from twenty years of improvement in intensive care, diagnostic assays and supportive treatment. That limitation is not a reason to dismiss the result; it is the reason the result is an inference rather than a measurement.
Written into the record, not signed off as a reviewed claim
The composite moved on new thrombosis; death and amputation did not differ
In plain words
The confirmatory study said so directly: there was no significant difference in deaths or amputations. What improved was the number of new clots, which is the least severe of the three things the endpoint counted.
What was measured
Components of the composite endpoint reported separately: new thrombosis reduced, all-cause death and amputation not significantly different
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
ARG-915 was a multicentre non-randomised prospective study in which 418 patients received argatroban for a mean of five to seven days, compared with 185 historical controls. The composite endpoint was 28.0% against 38.8% in isolated thrombocytopenia (p=0.04) and 41.5% against 56.5% in thrombocytopenia with thrombosis (p=0.07). The published results state in as many words that "there were no significant between-group differences in all-cause death or amputation" and that what argatroban significantly reduced was new thrombosis, plus death due to thrombosis in the thrombosis arm. A composite endpoint that combines death, amputation and new thrombosis, and moves entirely on the third of those, is doing something specific and worth naming. Platelet counts also recovered faster and bleeding rates were similar between the groups.
Written into the record, not signed off as a reviewed claim
The coronary intervention indication rests on a subjective assessment in 91 patients
In plain words
For use during heart procedures, the two primary measures of success were an operator’s judgment that the procedure went satisfactorily and that anticoagulation was adequate. There was no control group at all.
What was measured
Operator-assessed satisfactory procedural outcome (94.5%) and adequate anticoagulation (97.8%) in 91 single-arm patients
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The percutaneous coronary intervention indication comes from a study in which 91 patients with heparin-induced thrombocytopenia underwent 112 procedures on intravenous argatroban at 25 micrograms per kilogram per minute after a 350 microgram per kilogram bolus, adjusted to an activated clotting time of 300 to 450 seconds. The published primary efficacy endpoints were, in the authors’ own words, "subjective assessments of the satisfactory outcome of the procedure and adequate anticoagulation during PCI". 94.5% had a satisfactory outcome and 97.8% achieved adequate anticoagulation. Death, myocardial infarction or revascularisation at 24 hours occurred in 7 of 91 patients (7.7%) — no deaths, four infarctions, four revascularisations — and one patient (1.1%) had periprocedural major bleeding. The authors compared these outcomes with figures "historically reported for heparin", which is a second historical comparison layered on a single-arm study. The conclusion they drew is appropriately modest: argatroban is "a reasonable anticoagulant option in this setting, where current options are limited".
Written into the record, not signed off as a reviewed claim
MOST: three times the placebo mortality when argatroban was finally randomised
In plain words
The one trial that gave argatroban a genuine placebo comparison was in stroke, and it went badly. Nearly a quarter of the argatroban patients were dead at 90 days, against 8% on placebo, and disability was worse.
What was measured
Utility-weighted 90-day modified Rankin scale score and 90-day mortality against placebo
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
MOST (NCT03735979) was a phase 3, three-group, adaptive, single-blind randomised controlled trial at 57 United States sites in 514 patients with acute ischaemic stroke who had received intravenous thrombolysis within three hours of onset, assigned to intravenous argatroban (59 patients), eptifibatide (227) or placebo (228) within 75 minutes of starting thrombolysis. At 90 days the mean utility-weighted modified Rankin scale score was 5.2 ± 3.7 with argatroban against 6.8 ± 3.0 with placebo, higher being better. The posterior probability that argatroban was better than placebo was 0.002, with a posterior mean difference of -1.51 ± 0.51 — that is, the trial concluded with high confidence that argatroban was worse. Mortality at 90 days was 24% with argatroban against 8% with placebo, while symptomatic intracranial haemorrhage was similar across the groups at 4%, 3% and 2%. This is outside the approved indications, and it is also the only placebo-controlled randomised evidence this molecule has: a drug whose approved uses rest on historical controls and subjective endpoints, tested properly once, in a different disease, with this result.
Written into the record, not signed off as a reviewed claim
ARAIS: adding argatroban to clot-busting treatment changed nothing in 817 patients
In plain words
A large Chinese trial tested whether adding argatroban to standard clot-dissolving treatment for stroke improved recovery. It did not: 63.8% versus 64.9% made an excellent recovery.
What was measured
Modified Rankin scale score of 0 to 1 at 90 days, argatroban plus alteplase against alteplase alone
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
ARAIS (NCT03740958) was a multicentre, open-label, blinded-endpoint randomised trial in 817 randomised patients with acute ischaemic stroke at 50 hospitals in China, comparing argatroban plus alteplase (402 assigned) with alteplase alone (415 assigned) within 4.5 hours of symptom onset. Excellent functional outcome — a modified Rankin scale score of 0 to 1 at 90 days — occurred in 210 of 329 (63.8%) against 238 of 367 (64.9%), risk difference -1.0% (95% CI -8.1% to 6.1%), risk ratio 0.98 (95% CI 0.88 to 1.10), p=0.78. Symptomatic intracranial haemorrhage was 2.1% against 1.8% and major systemic bleeding 0.3% against 0.5%. A flat negative result with no safety signal, published in JAMA a year before MOST reported the mortality difference in a different population.
Written into the record, not signed off as a reviewed claim
It reaches thrombin inside an existing clot, which heparin cannot
In plain words
Heparin works by supercharging a large blood protein, and that protein is too bulky to get into a clot that has already formed. Argatroban is small enough to reach the thrombin trapped inside.
What was measured
Thrombin inhibition constant 0.04 micromolar, with activity against clot-associated as well as free thrombin
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The United States label states that argatroban "is capable of inhibiting the action of both free and clot-associated thrombin", with an inhibition constant of 0.04 micromolar and no requirement for antithrombin III. It inhibits thrombin-catalysed fibrin formation, activation of factors V, VIII and XIII, activation of protein C, and thrombin-mediated platelet aggregation, while having little or no effect on trypsin, factor Xa, plasmin or kallikrein at therapeutic concentrations. The clot-associated point is a genuine pharmacological advantage over heparin and it is a mechanistic property, measured in vitro: the trials that would show it translating into better clinical outcomes than heparin have never been run, because running them in heparin-induced thrombocytopenia would mean giving heparin to patients who cannot have it.
Source
Argatroban injection, United States prescribing information, section 12.1 Mechanism of Action
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
It lengthens the INR by itself, so the INR stops meaning what people assume
In plain words
The standard blood test used to judge warfarin is pushed up by argatroban on its own. A number that looks like enough warfarin may be mostly argatroban.
What was measured
That an international normalised ratio measured during an argatroban infusion reflects vitamin K antagonist effect — the assay is prolonged by argatroban itself, variably by reagent, and reads something other than what it is assumed to read
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Argatroban prolongs the prothrombin time and therefore the international normalised ratio independently of any vitamin K antagonist, because both assays end with a thrombin-dependent step. The label devotes a section of its dosage instructions to this interference and notes that above 2 micrograms per kilogram per minute "the relationship of INR between warfarin alone to the INR on warfarin plus argatroban is less predictable". The magnitude of the effect also varies with the thromboplastin reagent a given laboratory uses, so the same patient can produce different numbers in different hospitals. This is not a drug interaction in the pharmacological sense — nothing about warfarin’s effect changes — it is an artefact of the measurement, and the chromogenic factor X assay is insensitive to argatroban and reads the vitamin K antagonist effect alone. A number that is misread is worse than no number, and this is one of the clearest examples of that in hospital pharmacology.
Source
Argatroban injection, United States prescribing information, section 2 Dosage and Administration, conversion to oral anticoagulant therapy
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
caution
Review state
Written into the record, not signed off as a reviewed claim
The liver clears it, which is why it survives in kidney failure — and the reverse
In plain words
Almost every other anticoagulant leaves through the kidneys. This one leaves through the liver, which makes it usable in someone on dialysis and risky in someone with liver disease.
What was measured
Elimination half-life 39 to 51 minutes, steady state in 1 to 3 hours, hepatic clearance with no renal dose restriction
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Argatroban reaches steady state within 1 to 3 hours of starting an infusion, with an elimination half-life of 39 to 51 minutes and low between-subject variability. Clearance is hepatic. The label’s warnings section requires a lower starting dose and careful titration in patients with heparin-induced thrombocytopenia who have moderate or severe hepatic impairment, and says to avoid use during percutaneous coronary intervention in patients with clinically significant hepatic impairment — but sets no renal restriction at all. That asymmetry is the practical reason argatroban is chosen: heparin-induced thrombocytopenia is common in intensive care, where renal failure is common and where fondaparinux is contraindicated and the low molecular weight heparins accumulate. There is no reversal agent, and the short half-life is the only exit.
Source
Argatroban injection, United States prescribing information, sections 5.2 and 12 Clinical Pharmacology
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
How many documents were read
17 documents were read for this substance.
RNAWiki source record
17 of them state the same proteinBinding, and they agree.
RNAWiki source record
17 of them state the same volumeOfDistribution, and they agree.
RNAWiki source record
Where else this substance is registered
FDA substance identifier (UNII)
IY90U61Z3S
RxNorm concept
1804737
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How this medicine reached us
Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.
What the approval register records
18 approved applications cover products containing this substance. The earliest was NDA020883, approved 20000630 to SANDOZ.
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What is not here
7 questions this page could not answer
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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 direct thrombin blocker given by infusion when heparin has triggered an immune clotting reaction, approved on a composite endpoint compared against a historical control cohort rather than a randomised one — where the reduction came from new thrombosis, while death and amputation did not differ — and which raised 90-day mortality from 8% to 24% in the only placebo-controlled trial it has ever been in.
Recorded evidence blocks (9)
Q2
On the Argatroban Anhydrous label: indicated for what?
"Argatroban is a direct thrombin inhibitor indicated: For prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HIT) ( 1.1 ) As an anticoagulant in adult patients with or at risk for HIT undergoing percutaneous coronary intervention (PCI) ( 1 .2 ) 1.1 Heparin-Induced…": indications and usage on Argatroban Anhydrous's label. DailyMed label · 1a67a87d-59cb-414c-a11e-ab8f0a9bb778 · 2026-08-20
Q3
25 registered trials of Argatroban Anhydrous — at which phases?
Registered studies posting no result
16 of 25
25 registered studies of Argatroban Anhydrous: 9 phase4, 8 phase2, 5 phase3, 2 na or unstated, 2 phase1, 1 na. CLINICALTRIALS_SNAPSHOT · 2026-09-01
91 with a PubMed record
Show the evidence
phase4
9
phase2
8
phase3
5
na or unstated
2
phase1
2
na
1
2 more recorded rows
completed
21
terminated
4
recorded 2026-09-01 · last checked 2026-09-04
Q4
4 of Argatroban Anhydrous's trials stopped: accrual/recruitment, funding/business, other?
accrual/recruitment (1), funding/business (1) and other (2): Argatroban Anhydrous's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01
"Supply of Lepirudin ended on 01. April 2012, thus trial terminated on 31. March 2012"; 4 of 25 registered studies
Show the evidence
Trial
NCT00798525
terminated; "Supply of Lepirudin ended on 01. April 2012, thus trial terminated on 31. March 2012"
NCT01464788
terminated; "The study was halted prematurely at 90 of 105 planned patients due to the beneficial results of embolectomy clinical trials."
NCT03809481
terminated; "Prolonged delay as a result of impact of Covid19 pandemic"
NCT04406389
terminated; "Low accrual"
recorded 2026-09-01 · last checked 2026-09-04
Q5
Argatroban Anhydrous's half-life is 51 minutes — which schedules were studied?
51 minutes; The terminal elimination half-life of argatroban ranges between 39 and 51 minutes.
metabolismpharmacokinetics
Metabolism: The main route of argatroban metabolism is hydroxylation and aromatization of the 3-methyltetrahydroquinoline ring in the liver.
recorded 2026-08-20 · last checked 2026-09-04
Q6
Which 14 trials of Argatroban Anhydrous posted no result?
Posted no result
14 of 14 completed trials
Registrations
NCT00035178, NCT00039858, NCT00198588, NCT01980316, NCT01734252 and NCT01911624, and 8 more
Completion dates
oldest 2002-11; newest 2024-07-07
Show the evidence
Trial
NCT00035178
2002-11
NCT00039858
2006-03
NCT00198588
2006-09
NCT01980316
2013-07
NCT01734252
2016-04-01
NCT01911624
2016-07
8 further recorded trials
NCT02448069
2016-08
NCT02935530
2017-10
NCT03740958
2022-01-30
NCT05325346
2022-04-14
NCT04275180
2023-01-31
NCT04925167
2023-12-31
NCT06038682
2023-12-31
NCT05226442
2024-07-07
Q7
At the median, Argatroban Anhydrous's trials enrolled 65 people — anything larger?
Median enrolment
65
Largest enrolment
808
Registered trials counted
25
Q8
What do 342 spontaneous reports say about Argatroban Anhydrous — 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.
Argatroban Anhydrous appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 342 reaction mentions were counted: international normalised ratio increased 88; activated partial thromboplastin time prolonged 58; coagulation time prolonged 50; heparin-induced thrombocytopenia 45. FAERS via Open Targets · CHEMBL1166 · 2026-06-24
Show the evidence
international normalised ratio increased
88
activated partial thromboplastin time prolonged
58
coagulation time prolonged
50
heparin-induced thrombocytopenia
45
haemorrhage
21
gastrointestinal haemorrhage
20
4 more recorded rows
cerebral infarction
17
hepatic function abnormal
16
aspartate aminotransferase increased
14
deep vein thrombosis
13
recorded 2026-06-24 · last checked 2026-09-04
Q9
Which 10 reactions does Argatroban Anhydrous's label not list?
activated partial thromboplastin time prolonged, aspartate aminotransferase increased and cerebral infarction and 7 more reported for Argatroban Anhydrous, absent from its label. FAERS via Open Targets · CHEMBL1166 · 2026-06-24
3 label terms; 10 reported and unlisted; 1a67a87d-59cb-414c-a11e-ab8f0a9bb778
Show the evidence
activated partial thromboplastin time prolonged
count not stated
aspartate aminotransferase increased
count not stated
cerebral infarction
count not stated
coagulation time prolonged
count not stated
deep vein thrombosis
count not stated
gastrointestinal haemorrhage
count not stated
4 more recorded rows
haemorrhage
count not stated
heparin-induced thrombocytopenia
count not stated
hepatic function abnormal
count not stated
international normalised ratio increased
count not stated
recorded 2026-06-24 · last checked 2026-09-04
Q10
Argatroban Anhydrous and CYP3A4 and CYTOCHROME P450: shared by which compounds?
The formation of each of the 4 known metabolites is catalyzed in vitro by the human liver microsomal cytochrome P450 enzymes CYP3A4/5.
pharmacokinetics
These data, together with the lack of effect of erythromycin (a potent CYP3A4/5 inhibitor) on argatroban pharmacokinetics, suggest that CYP3A4/5-mediated metabolism is not an important elimination pathway in vivo .
pharmacokinetics
Erythromycin: In 10 healthy subjects, orally administered erythromycin (a potent inhibitor of CYP3A4/5) at 500 mg four times daily for 7 days had no effect on the pharmacokinetics of argatroban at a dose of 1 mcg/kg/min for 5 hours.
pharmacokinetics
These data suggest oxidative metabolism by CYP3A4/5 is not an important elimination pathway in vivo for argatroban.
clinical_pharmacology
The formation of each of the 4 known metabolites is catalyzed in vitro by the human liver microsomal cytochrome P450 enzymes CYP3A4/5.
clinical_pharmacology
These data, together with the lack of effect of erythromycin (a potent CYP3A4/5 inhibitor) on argatroban pharmacokinetics, suggest that CYP3A4/5-mediated metabolism is not an important elimination pathway in vivo .
2 more recorded rows
Interaction statementclinical_pharmacology
Erythromycin: In 10 healthy subjects, orally administered erythromycin (a potent inhibitor of CYP3A4/5) at 500 mg four times daily for 7 days had no effect on the pharmacokinetics of argatroban at a dose of 1 mcg/kg/min for 5 hours.
Interaction statementclinical_pharmacology
These data suggest oxidative metabolism by CYP3A4/5 is not an important elimination pathway in vivo for argatroban.
ChEMBL 37 — CC BY-SA 3.0 Unported · ChEMBL ATC CC BY-SA · ClinicalTrials.gov — US Government work · Open Targets 26.06 — CC0 · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work
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