This page shows what was measured, who it was measured in, and what that does not settle.
What Bivalirudin does in the body
Preventing clots during a procedure to open a blocked heart artery.
Thrombin is the enzyme that builds a clot, and it has two working parts: a cutting site and a separate groove it uses to grip what it is about to cut. Bivalirudin is a short designed peptide with one end that plugs the cutting site and another that fills the groove, joined by a flexible linker — so it holds thrombin in two places at once. What makes it unusual is that thrombin slowly cuts the drug off itself, which is why the effect fades within about 25 minutes of stopping the infusion. That short life is both the reason it bleeds less and the reason clots can form on a new stent once it wears off.
What happened in people
It caused less bleeding than heparin plus another powerful platelet medicine, but lost to heparin alone in one study.
✓ 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 strongest wins used a comparison combination that is now uncommon.
Where it acts
Blood plasma and the coronary artery lumen during the procedure — including thrombin already bound within a clot on the vessel wall
Kind of result
The kind of result is not recorded
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 protein.
FDA substance registry · TN9BEX005G · read 2026-08-29
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.
The limit a reviewer approved as the one that matters most here.
The four opening statements run to 148 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.
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.
Pathway
A pathway is a chain of steps inside a cell, each one setting off the next.
A picture of it, and where the picture fails
A pathway is like a row of dominoes.
Where that stops being true. Dominoes fall one way. Pathways loop back and can switch themselves off.
What people get wrong. Changing one step is read as changing the outcome. Other steps often absorb it.
An ordered series of molecular interactions producing a defined cellular change.
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 ischaemia, major bleeding, and net clinical outcome at 30 days, bivalirudin alone or with a glycoprotein IIb/IIIa inhibitor versus heparin or enoxaparin plus a glycoprotein IIb/IIIa inhibitor
Bivalirudin alone vs heparin plus glycoprotein inhibitor: ischaemia 7.8% vs 7.3% (RR 1.08, 95% CI 0.93 to 1.24, p=0.32); major bleeding 3.0% vs 5.7% (RR 0.53, p<0.001); net outcome 10.1% vs 11.7% (RR 0.86, p=0.02)
Repeated elsewhere
Failed to Replicate
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 bivalirudin-plus-glycoprotein-inhibitor arm was non-inferior on every endpoint and superior on none, indicating that the bleeding benefit came from omitting the glycoprotein inhibitor rather than from bivalirudin. Open-label design.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Intravenous bolus followed by continuous infusion, catheter laboratory use only
Interval reported. 95% CI 0
Written into the record, not signed off as a reviewed claim.
Major bleeding and net adverse clinical events at 30 days, bivalirudin alone versus heparin plus a glycoprotein IIb/IIIa inhibitor in primary percutaneous coronary intervention
Net adverse clinical events 9.2% vs 12.1% (RR 0.76, 95% CI 0.63 to 0.92, p=0.005); major bleeding 4.9% vs 8.3% (RR 0.60, p<0.001); cardiac death 1.8% vs 2.9% (p=0.03)
Repeated elsewhere
Failed to Replicate
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. Acute stent thrombosis within 24 hours was increased in the bivalirudin group, though the excess was no longer significant at 30 days. Open-label, and the comparator regimen has since largely fallen out of use.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Intravenous bolus followed by continuous infusion, catheter laboratory use only
Interval reported. 95% CI 0
Written into the record, not signed off as a reviewed claim.
Composite of all-cause death, stroke, reinfarction or unplanned target lesion revascularisation, bivalirudin versus unfractionated heparin 70 U/kg in primary percutaneous coronary intervention
✗ The study did not show it
Who was studied
HEAT-PPCI (NCT01519518)
How many people
1829
Study design
Randomised open-label single-centre trial with delayed consent, 28-day endpoint
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
8.7% (79/905) on bivalirudin vs 5.7% (52/907) on heparin, absolute difference 3.0 percentage points, RR 1.52 (95% CI 1.09 to 2.13), p=0.01 — bivalirudin worse
Repeated elsewhere
Partially 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 bleeding advantage: BARC 3-5 major bleeding 3.5% vs 3.1% (p=0.59). Single centre and open label, but with a delayed-consent design capturing 97% of trial-naive presentations, which removes most selection bias.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Intravenous bolus followed by continuous infusion, catheter laboratory use only
Interval reported. 95% CI 1
Written into the record, not signed off as a reviewed claim.
Major adverse cardiovascular events and net adverse clinical events, bivalirudin versus unfractionated heparin in acute coronary syndrome undergoing percutaneous coronary intervention
✗ The study did not show it
Who was studied
MATRIX (NCT01433627)
How many people
7213
Study design
Phase 3 randomised open-label trial with a nested second randomisation
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
MACE 10.3% vs 10.9% (RR 0.94, 95% CI 0.81 to 1.09, p=0.44); net adverse clinical events 11.2% vs 12.4% (RR 0.89, 0.78 to 1.03, p=0.12) — both missed
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. The nested comparison of a post-procedure bivalirudin infusion against none also missed: 11.0% vs 11.9% (RR 0.91, 0.74 to 1.11, p=0.34). That negative result is difficult to reconcile with BRIGHT-4.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Intravenous bolus followed by continuous infusion, catheter laboratory use only
Interval reported. 95% CI 0
Written into the record, not signed off as a reviewed claim.
Composite of death from any cause, myocardial infarction or major bleeding at 180 days, bivalirudin versus heparin monotherapy in myocardial infarction treated with radial access and a potent P2Y12 inhibitor
12.3% vs 12.8%, hazard ratio 0.96 (95% CI 0.83 to 1.10), p=0.54. Major bleeding 8.6% vs 8.6%, hazard ratio 1.00, p=0.98
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. Results were consistent across ST-elevation and non-ST-elevation subgroups. Open label; the identical bleeding rates indicate that radial access had already removed the risk the drug was designed to reduce.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Intravenous bolus followed by continuous infusion, catheter laboratory use only
Interval reported. 95% CI 0
Written into the record, not signed off as a reviewed claim.
Composite of all-cause death or BARC 3-5 bleeding at 30 days, bivalirudin with a 2 to 4 hour post-procedure high-dose infusion versus unfractionated heparin monotherapy in primary percutaneous coronary intervention
✓ The study showed what it set out to show
Who was studied
BRIGHT-4 (NCT03822975)
How many people
6016
Study design
Investigator-initiated randomised open-label trial, 87 centres in China, 30-day endpoint
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
3.06% (92/3009) vs 4.39% (132/3007), difference 1.33 percentage points (95% CI 0.38 to 2.29), HR 0.69 (0.53 to 0.91), p=0.0070. All-cause death 2.96% vs 3.92% (p=0.0420); BARC 3-5 bleeding 0.17% vs 0.80% (p=0.0014)
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. Open label, single country, and using a higher post-procedure infusion dose than the one MATRIX tested and found ineffective. Reinfarction, stroke and ischaemia-driven revascularisation did not differ.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Intravenous bolus followed by continuous infusion, catheter laboratory use only
Interval reported. 95% CI 0
Written into the record, not signed off as a reviewed claim.
RNAWiki holds 6 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.9 registered measures of this kind. 2 written-up studies measured this and did not show a benefit.
□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.1 registered measure 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.
■AnimalsEvidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.Stored records in Rat. A result in animals says what to test next. It does not say what happens in people.
□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
Bivalirudin
What a person takes: Intravenous bolus followed by continuous infusion, catheter laboratory use only.
The measurement behind this step
A weight-based intravenous bolus followed by a continuous infusion, given during percutaneous coronary intervention. Supplied both as a lyophilised powder for reconstitution and as a ready-to-use premixed solution. Anticoagulant effect is immediate and, on stopping, disappears within roughly 25 minutes in patients with normal renal function. Monitored in the catheter laboratory by activated clotting time.
Getting in
A bolus and infusion during the procedure only
Given intravenously in the catheter laboratory, as a single push followed by a drip that usually runs for the length of the procedure.
╌╌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 20-residue synthetic peptide, 2180.30 g/mol, administered as a weight-based bolus with a continuous infusion. Steady state is reached within minutes. The elimination half-life is roughly 25 minutes with normal renal function and lengthens as creatinine clearance falls, because clearance is partly renal and partly proteolytic.
Thrombin has a cutting site and a separate groove it uses to hold what it is cutting. This drug is built with one end for each, joined by a flexible chain.
╌╌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
Bivalent binding: the D-phenylalanyl-prolyl-arginyl amino terminus occupies the catalytic active site while the acidic carboxy-terminal dodecapeptide, derived from the tail of leech hirudin, occupies exosite 1. A tetraglycine linker spans them. Initial affinity is extremely high, and no antithrombin cofactor is required.
Clot-bound thrombin is reachable, unlike with heparin
Thrombin trapped inside an existing clot keeps that clot growing. Heparin cannot get to it. This peptide 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 too large to reach thrombin bound to fibrin within a formed thrombus. Bivalirudin at 2.18 kDa inhibits clot-associated thrombin directly, which is the pharmacological argument for using it where fresh thrombus is present on a ruptured plaque.
The enzyme it blocks slowly slices through the drug, freeing itself. Within about 25 minutes of stopping the drip, clotting is back to normal.
╌╌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
Thrombin cleaves the Arg3-Pro4 bond of the bound bivalirudin molecule, releasing active enzyme and leaving the peptide fragments to be cleared. Inhibition is therefore self-terminating by design rather than by metabolism, which is unusual: the target is the principal off-switch.
Less bleeding, and a window where a new stent is unprotected
Serious bleeding falls compared with older combination regimens. The trade is a period in the first day when clots can form on the freshly placed stent.
╌╌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
Major bleeding 4.9% against 8.3% in HORIZONS-AMI and 3.0% against 5.7% in ACUITY, against heparin plus a glycoprotein IIb/IIIa inhibitor. Acute stent thrombosis within 24 hours rose in HORIZONS-AMI. Against plain heparin the bleeding advantage disappeared entirely — 3.5% against 3.1% in HEAT-PPCI, 8.6% against 8.6% in VALIDATE-SWEDEHEART — while BRIGHT-4, adding a 2 to 4 hour post-procedure infusion, produced 0.17% against 0.80% BARC 3-5 bleeding and 0.37% against 1.10% stent thrombosis.
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.
maximum concentration as measured by pk sampling
Meaningful
Things that change how a life goes, not only a number.
death
stroke
stent arm death reinfarction stroke or stent thrombosis
major adverse cardiovascular events
death myocardial infarction and major bleeding event
composite of all cause death or barc type 3 5 bleeding
major adverse cardiac events
symptomatic stroke
circuit change free survival primarily due to thrombus
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 (28)
major bleeding events
primary endpoint
q wave mi
repeat coronary revascularization
stent arm ischemic target lesion revascularization
primary outcome measure will be in hospital major bleeding
major bleeding and mace
bleeding events
major bleeding at 48 hours or before hospital discharge
net adverse clinical events at up to 30 days
net adverse clinical events
thrombotic complications
cmr assessment of infarct size at day 5
creatine kinase mb increase
major bleeding
rate of net adverse clinical events
elimination rate constant as measured by pk sampling
half life as measured by pk sampling
absorption rate constant as measured by pk sampling
auc as measured by pk sampling
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. 3.5 hours hours
Read from the label, which states: “In dialysis patients, clearance was reduced by 70%, with a half-life of 3.5 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.
Patients undergoing percutaneous coronary intervention, particularly those at high bleeding risk, and patients with heparin-induced thrombocytopenia who need a coronary procedure and cannot receive heparin.
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: “The safety and effectiveness of bivalirudin in pediatric patients have not been established.”
US prescribing information · 26fb46f6-0088-42b8-b6f2-c67224776803 · read 2026-08-30
On older people, the label states: “In studies of patients undergoing PCI, 44% were ≥65 years of age and 12% of patients were ≥75 years old.”
US prescribing information · 26fb46f6-0088-42b8-b6f2-c67224776803 · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary There are no data available on use of bivalirudin in pregnant women to inform a drug-associated risk of adverse developmental outcomes.”
US prescribing information · 26fb46f6-0088-42b8-b6f2-c67224776803 · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary It is not known whether bivalirudin is present in human milk.”
US prescribing information · 26fb46f6-0088-42b8-b6f2-c67224776803 · read 2026-08-30
On people with reduced kidney function, the label states: “The disposition of bivalirudin was studied in PTCA patients with mild, moderate and severe renal impairment.”
US prescribing information · 26fb46f6-0088-42b8-b6f2-c67224776803 · read 2026-08-30
Where the result stopped carrying
Acute stent thrombosis within 24 hours in HORIZONS-AMI, the complication the drug is given to prevent
HEAT-PPCI, where ischaemic events rose from 5.7% to 8.7% against plain heparin with no bleeding offset
Both primary endpoints of MATRIX, and the nested post-procedure infusion comparison inside it
VALIDATE-SWEDEHEART, where 180-day outcomes and major bleeding were identical in modern radial-access practice
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
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
Intravenous bolus followed by continuous infusion, catheter laboratory 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
A weight-based intravenous bolus followed by a continuous infusion, given during percutaneous coronary intervention. Supplied both as a lyophilised powder for reconstitution and as a ready-to-use premixed solution. Anticoagulant effect is immediate and, on stopping, disappears within roughly 25 minutes in patients with normal renal function. Monitored in the catheter laboratory by activated clotting time.
✎ 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
Bleeding is the principal risk, and the access site is where most of it occurs. Clearance is partly proteolytic and partly renal, so the half-life lengthens in renal impairment and the label carries a dose reduction. There is no reversal agent; the short half-life is the only exit, and it is also the reason acute stent thrombosis appeared within 24 hours in HORIZONS-AMI. Hypersensitivity and anaphylaxis have been reported. Bivalirudin does not cross-react with heparin-induced thrombocytopenia antibodies, which is the basis of its role in that population.
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.
Bivalirudin appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 731 reaction mentions were counted. One report can name several reactions.
international normalised ratio increased — 41 reaction mentions
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
Intravenous bolus followed by continuous infusion, catheter laboratory 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
Supplied both as a lyophilised powder for reconstitution and as a ready-to-use premixed solution. Anticoagulant effect is immediate and, on stopping, disappears within roughly 25 minutes in patients with normal renal function. Monitored in the catheter laboratory by activated clotting time.
✎ 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
26 products list this as an active ingredient in the United States drug directory. 26 of them contain it and nothing else.
FDA National Drug Code directory · 55111-918 · read 2026-08-29
They are sold as injection, injection, powder, lyophilized, for solution, injection, powder, lyophilized, for suspension, injection, solution and powder, taken intracavernous and intravenous.
FDA National Drug Code directory · 55111-918 · 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 · 55111-918 · read 2026-08-29
15 published labels name it as an active ingredient. 15 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · 26fb46f6-0088-42b8-b6f2-c67224776803 · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 26fb46f6-0088-42b8-b6f2-c67224776803 · read 2026-08-29
BIVALIRUDIN is intravenous at 3 DOSAGE FORMS AND STRENGTHS Bivalirudin for Injection: 250 mg of bivalirudin as a lyophilized powder in a single-dose vial for reconstitution., recorded as fda label in effect 2024-04-04 in the United States.
US prescribing information · 26fb46f6-0088-42b8-b6f2-c67224776803 · 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 Bivalirudin 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 bivalirudin is safer than heparin — the winning trials compared it against heparin plus a glycoprotein IIb/IIIa inhibitor, and against heparin alone the bleeding advantage vanished in three separate trials
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 the bleeding advantage was a property of the thrombin inhibitor — ACUITY’s third arm showed it disappeared as soon as a glycoprotein inhibitor was added back to bivalirudin
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 a post-procedure infusion resolves the stent thrombosis problem — MATRIX tested that question and found nothing (p=0.34); BRIGHT-4 used a higher dose in a single country and found a benefit
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 the mortality signals are real drug effects — HORIZONS-AMI and BRIGHT-4 both found lower mortality, MATRIX, VALIDATE-SWEDEHEART and HEAT-PPCI 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.
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 Bivalirudin 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.
ACUITY: major bleeding nearly halved against heparin plus a platelet blocker
In plain words
In 13,819 patients with unstable heart disease, bivalirudin used on its own caused about half as many serious bleeds as heparin combined with a powerful platelet drug, with the same number of heart attacks.
What was measured
Major bleeding at 30 days, 3.0% on bivalirudin alone against 5.7% on heparin plus a glycoprotein IIb/IIIa inhibitor
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
ACUITY (NCT00093158) randomised 13,819 patients with moderate- or high-risk acute coronary syndromes to heparin or enoxaparin plus a glycoprotein IIb/IIIa inhibitor, bivalirudin plus a glycoprotein IIb/IIIa inhibitor, or bivalirudin alone. Bivalirudin alone against heparin plus a glycoprotein inhibitor: composite ischaemia at 30 days 7.8% against 7.3% (relative risk 1.08, 95% CI 0.93 to 1.24, p=0.32), meeting non-inferiority; major bleeding 3.0% against 5.7% (relative risk 0.53, 95% CI 0.43 to 0.65, p<0.001); net clinical outcome 10.1% against 11.7% (relative risk 0.86, 95% CI 0.77 to 0.97, p=0.02). Bivalirudin plus a glycoprotein inhibitor was non-inferior on all three and better on none, which is itself informative: the bleeding advantage came from leaving the glycoprotein inhibitor out, not from the thrombin inhibitor.
Written into the record, not signed off as a reviewed claim
The comparator in the winning trials was a regimen that has since fallen out of use
In plain words
Both trials that made this drug standard compared it against heparin plus an extra powerful platelet drug. That combination is now uncommon, so the wins describe a comparison most patients will never face.
What was measured
That bivalirudin is safer than heparin — the trials compared it against heparin plus a glycoprotein IIb/IIIa inhibitor, and the arm that added a glycoprotein inhibitor to bivalirudin lost the bleeding advantage entirely
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
In ACUITY the control arm received heparin or enoxaparin plus a glycoprotein IIb/IIIa inhibitor; in HORIZONS-AMI it received heparin plus a glycoprotein IIb/IIIa inhibitor. Routine glycoprotein IIb/IIIa inhibition during percutaneous coronary intervention has since largely been abandoned, displaced by potent oral P2Y12 inhibitors and by radial access. ACUITY’s own three-arm design shows why this matters: bivalirudin plus a glycoprotein inhibitor was non-inferior to heparin plus a glycoprotein inhibitor on ischaemia, bleeding and net outcome alike — 7.7% against 7.3%, 5.3% against 5.7%, 11.8% against 11.7% — so all of the benefit attributed to bivalirudin came from dropping the glycoprotein inhibitor rather than from the thrombin inhibitor itself. That is a comparison between regimens, and it was read for a decade as a comparison between drugs.
Written into the record, not signed off as a reviewed claim
HORIZONS-AMI: acute stent thrombosis in the first 24 hours rose more than fourfold
In plain words
The same trial that showed less bleeding also showed more clots forming on the new stent within the first day — the exact complication the drug is supposed to prevent.
What was measured
Acute stent thrombosis within 24 hours, increased on bivalirudin, alongside major bleeding 4.9% against 8.3%
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
HORIZONS-AMI (NCT00433966) randomised 3,602 patients with ST-elevation myocardial infarction presenting within 12 hours and undergoing primary percutaneous coronary intervention to heparin plus a glycoprotein IIb/IIIa inhibitor or bivalirudin alone. Net adverse clinical events at 30 days were 9.2% against 12.1% (relative risk 0.76, 95% CI 0.63 to 0.92, p=0.005), driven by major bleeding 4.9% against 8.3% (relative risk 0.60, 95% CI 0.46 to 0.77, p<0.001). Cardiac death was 1.8% against 2.9% (relative risk 0.62, p=0.03) and all-cause death 2.1% against 3.1% (relative risk 0.66, p=0.047). Against that, the publication reports an increased risk of acute stent thrombosis within 24 hours in the bivalirudin group, with no significant increase remaining at 30 days. The mechanism is the drug’s own design: bivalirudin is cleaved by the thrombin it inhibits and its effect fades in about 25 minutes, leaving a fresh stent unprotected at the moment thrombin generation rebounds. Every subsequent regimen change — the post-procedure infusion in BRIGHT-4 — is an attempt to close that window.
Written into the record, not signed off as a reviewed claim
HEAT-PPCI: against plain heparin it lost, and had no bleeding advantage at all
In plain words
When someone finally compared bivalirudin with ordinary heparin alone, bivalirudin came out worse — more heart attacks and deaths, and no reduction in serious bleeding.
What was measured
Composite of death, stroke, reinfarction or unplanned target lesion revascularisation at 28 days, 8.7% against 5.7% on heparin
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
HEAT-PPCI (NCT01519518) was an open-label single-centre randomised trial in 1,829 consecutive adults presenting for primary percutaneous coronary intervention at Liverpool Heart and Chest Hospital, using a delayed-consent design that captured 97% of trial-naive presentations — an unusually unselected population. Patients received heparin 70 U/kg or bivalirudin at standard bolus and infusion, with glycoprotein IIb/IIIa inhibitor use similar in both arms (13% and 15%). The primary efficacy composite of all-cause death, stroke, reinfarction or unplanned target lesion revascularisation occurred in 79 of 905 bivalirudin patients (8.7%) against 52 of 907 heparin patients (5.7%) — absolute risk difference 3.0 percentage points, relative risk 1.52 (95% CI 1.09 to 2.13), p=0.01. The primary safety outcome, BARC 3-5 major bleeding, was 3.5% against 3.1% (relative risk 1.15, 95% CI 0.70 to 1.89, p=0.59). The authors’ interpretation is blunt: heparin reduces ischaemic events with no increase in bleeding, and systematic use of heparin instead would reduce drug costs substantially. This is the trial that moved the field.
Written into the record, not signed off as a reviewed claim
MATRIX: both primary endpoints missed in 7,213 patients
In plain words
The largest trial of bivalirudin against ordinary heparin found no significant difference on either of its two main measures. A second question inside the same trial, about extending the infusion, also came back negative.
What was measured
Major adverse cardiovascular events and net adverse clinical events, bivalirudin against unfractionated heparin
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
MATRIX (NCT01433627) randomised 7,213 acute coronary syndrome patients scheduled for percutaneous coronary intervention to bivalirudin or unfractionated heparin, with the bivalirudin group further randomised to receive or not receive a post-procedure infusion. Major adverse cardiovascular events — death, myocardial infarction or stroke — occurred in 10.3% on bivalirudin against 10.9% on heparin (relative risk 0.94, 95% CI 0.81 to 1.09, p=0.44). Net adverse clinical events were 11.2% against 12.4% (relative risk 0.89, 95% CI 0.78 to 1.03, p=0.12). Both missed. The nested infusion question also missed: urgent target-vessel revascularisation, definite stent thrombosis or net adverse clinical events occurred in 11.0% with the post-procedure infusion against 11.9% without (relative risk 0.91, 95% CI 0.74 to 1.11, p=0.34). That last result sits awkwardly beside BRIGHT-4, which asked a similar question seven years later with a higher-dose infusion and got a positive answer.
Written into the record, not signed off as a reviewed claim
VALIDATE-SWEDEHEART: identical bleeding, identical outcomes, in modern practice
In plain words
In 6,006 heart attack patients treated the way they are treated today — through the wrist, with a modern platelet drug — bivalirudin and heparin produced the same results down to the decimal on bleeding.
What was measured
Composite of death, myocardial infarction or major bleeding at 180 days, and major bleeding alone (8.6% in both arms)
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
VALIDATE-SWEDEHEART (NCT02311231) was a registry-based randomised open-label trial in 6,006 patients — 3,005 with ST-elevation and 3,001 with non-ST-elevation myocardial infarction — undergoing percutaneous coronary intervention with a potent P2Y12 inhibitor and without planned glycoprotein IIb/IIIa inhibition, predominantly through radial access. The composite of death, myocardial infarction or major bleeding at 180 days occurred in 12.3% on bivalirudin against 12.8% on heparin (hazard ratio 0.96, 95% CI 0.83 to 1.10, p=0.54). The components: myocardial infarction 2.0% against 2.4% (p=0.33), major bleeding 8.6% against 8.6% (hazard ratio 1.00, p=0.98), definite stent thrombosis 0.4% against 0.7% (p=0.09), death 2.9% against 2.8% (p=0.76). The bleeding figure is the important one: identical. Radial access and the abandonment of routine glycoprotein inhibition had already removed the bleeding that bivalirudin existed to prevent.
Written into the record, not signed off as a reviewed claim
BRIGHT-4 reversed it again in 2022, by changing the regimen rather than the drug
In plain words
A Chinese trial in 6,016 heart attack patients kept the bivalirudin infusion running for two to four hours after the procedure. This time fewer people died, fewer bled, and fewer stents clotted.
What was measured
Composite of all-cause death or BARC 3-5 bleeding at 30 days, 3.06% against 4.39% on heparin monotherapy
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
BRIGHT-4 (NCT03822975) was an investigator-initiated open-label randomised trial at 87 centres in China in 6,016 patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention within 48 hours, 93.1% by radial access, comparing bivalirudin with a post-procedure high-dose infusion for 2 to 4 hours against unfractionated heparin monotherapy. The composite of all-cause death or BARC 3-5 bleeding at 30 days occurred in 92 of 3,009 bivalirudin patients (3.06%) against 132 of 3,007 heparin patients (4.39%) — difference 1.33 percentage points (95% CI 0.38 to 2.29), hazard ratio 0.69 (95% CI 0.53 to 0.91), p=0.0070. All-cause death was 2.96% against 3.92% (hazard ratio 0.75, 95% CI 0.57 to 0.99, p=0.0420), BARC 3-5 bleeding 0.17% against 0.80% (hazard ratio 0.21, 95% CI 0.08 to 0.54, p=0.0014), and stent thrombosis at 30 days 0.37% against 1.10% (p=0.0015). Reinfarction, stroke and ischaemia-driven revascularisation did not differ. Two things about this result need stating alongside it: MATRIX had tested a post-procedure infusion in the same class of patient and found nothing (p=0.34), and BRIGHT-4 used a higher infusion dose and was conducted entirely in one country. The field now holds two large positive trials, two large null trials and one negative trial, and which is right depends on a regimen detail rather than on the molecule.
Written into the record, not signed off as a reviewed claim
Its target destroys it, which is the whole of both its safety and its weakness
In plain words
Thrombin cuts the drug off itself and gets back to work. That is why the effect fades in about 25 minutes, why it bleeds less than a longer-acting drug, and why a fresh stent can clot once it wears off.
What was measured
Elimination half-life approximately 25 minutes, with stent thrombosis at 30 days of 0.37% on a post-procedure infusion against 1.10% on heparin monotherapy
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Bivalirudin binds thrombin bivalently — the D-Phe-Pro-Arg amino terminus in the catalytic site, the acidic hirudin-derived carboxy terminus in exosite 1 — and thrombin then cleaves the Arg3-Pro4 bond of the bound peptide, releasing itself. Inhibition is therefore transient by design, with an elimination half-life of about 25 minutes in normal renal function. Like all direct thrombin inhibitors it needs no antithrombin cofactor and reaches clot-bound thrombin, which heparin cannot. The clinical consequences of the short half-life run in both directions and both are measured: less bleeding than a longer-acting comparator in ACUITY and HORIZONS-AMI, and an excess of stent thrombosis within 24 hours in HORIZONS-AMI. BRIGHT-4’s post-procedure infusion is the direct pharmacological answer to the second, and it produced a 0.37% against 1.10% stent thrombosis rate in the direction that supports the explanation.
This order is fixed in code and does not count clicks or time on the page.
What is not here
4 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 was measured, goal by goal — found nothing in the sources checked.
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 thrombin blocker that cut major bleeding from 8.3% to 4.9% against heparin plus a glycoprotein inhibitor in 3,602 heart attack patients, then lost outright to plain heparin in a 1,829-patient trial where ischaemic events rose from 5.7% to 8.7% with no bleeding advantage at all — and then won again in 2022 when the infusion was continued after the procedure.
Recorded evidence blocks (11)
Q2
What did Bivalirudin's largest trial (6016 people) and its longest (8.8 years) measure?
6016 people in Bivalirudin's largest registered study, 8.8 years in its longest registered window, measuring Major Adverse Cardiac Events (MACE) in Terms of the Incidence of All Cause Mortality, Cerebrovascular Accident, Re-infarction and Additional Unplanned Target Lesion Revascularization. ClinicalTrials.gov · 2026-09-01
24 phase4, 17 phase3, 7 na, 5 phase2, 4 na or unstated, 1 phase1; NCT01084993; 2019-01. Last human test completed 2023, NCT03822975.
Interpretation These counts include studies where Bivalirudin 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
phase4
24
phase3
17
na
7
phase2
5
na or unstated
4
phase1
1
1 more recorded row
Last recorded human testNCT03822975
2023-05-06
recorded 2026-09-01 · last checked 2026-09-04
Q3
From rat to human: where has Bivalirudin shown lifespan?
Interpretation Major Adverse Cardiac Events (MACE) in Terms of the Incidence of All Cause Mortality, Cerebrovascular Accident, Re-infarction and Additional Unplanned Target… — the recorded outcome words.
Show the evidence
rat
mechanism-only
humanNCT01519518
lifespan; Major Adverse Cardiac Events (MACE) in Terms of the Incidence of All Cause Mortality, Cerebrovascular Accident, Re-infarction and Additional Unplanned Target Lesion Revascularization; 58
recorded 2026-09-01 · last checked 2026-09-04
Q4
4 of Bivalirudin's trials stopped: safety, futility/efficacy, accrual/recruitment, other?
safety (1), futility/efficacy (1), accrual/recruitment (1) and other (1): Bivalirudin's stop wording, clustered. ClinicalTrials.gov · 2026-09-01
"The study was discontinued early due to inadequate patient enrollment. No patients were enrolled."; 4 of 58 registered studies
Show the evidence
Trial
NCT00759083
withdrawn; "The study was discontinued early due to inadequate patient enrollment. No patients were enrolled."
NCT01464671
terminated; "DSMB halted the study early due to futility. There were no safety concerns."
NCT01848106
terminated; "Clinical Hold"
NCT02565147
terminated; "Futility at the interim analysis."
recorded 2026-09-01 · last checked 2026-09-04
Q5
Human studies of Bivalirudin used Bivalirudin 250 MG Injection — over how long?
1 recorded entry; human; also "Bivalirudin 250 MG Injection"
Show the evidence
humanNCT04532333
Bivalirudin 250 MG Injection
recorded 2026-09-01 · last checked 2026-09-04
Q6
Bivalirudin's half-life is 3.5 hours — which schedules were studied?
3.5 hours, the half-life Bivalirudin's label states. openfda-label · e574d04f-67b4-4a84-9d66-8c2d54f95120 · 2026-08-30
Show the evidence
half life
3.5 hours hours; In dialysis patients, clearance was reduced by 70%, with a half-life of 3.5 hours.
metabolism
The total body clearance of bivalirudin in PTCA patients with normal renal function is 3.4 mL/min/kg. Metabolism Bivalirudin is metabolized by proteolytic cleavage.
recorded 2026-08-30 · last checked 2026-09-04
Q7
Which of absorption rate constant as measured by pk sampling, auc as measured by pk sampling and bleeding did Bivalirudin's trials measure?
absorption rate constant as measured by pk sampling, auc as measured by pk sampling and bleeding lead 38 outcome terms across Bivalirudin's trials. ClinicalTrials.gov · 2026-09-01
Interpretation q wave mi, repeat coronary revascularization, stroke, stent arm ischemic target lesion revascularization, stent arm death reinfarction stroke or stent thrombosis and primary outcome measure will be in hospital major bleeding follow.
Show the evidence
major bleeding events
1
primary endpoint
1
death
1
q wave mi
1
repeat coronary revascularization
1
stroke
1
14 more recorded rows
stent arm ischemic target lesion revascularization
1
stent arm death reinfarction stroke or stent thrombosis
1
primary outcome measure will be in hospital major bleeding
1
major bleeding and mace
1
major adverse cardiovascular events
1
bleeding events
1
major bleeding at 48 hours or before hospital discharge
1
net adverse clinical events at up to 30 days
1
net adverse clinical events
1
death myocardial infarction and major bleeding event
1
thrombotic complications
1
cmr assessment of infarct size at day 5
1
creatine kinase mb increase
1
composite of all cause death or barc type 3 5 bleeding
1
recorded 2026-09-01 · last checked 2026-09-04
Q8
Which of Bivalirudin's 8 ongoing trials reports first?
Plasma Bivalirudin Concentration; Platelet Activity measured by the Index of Microcirculatory Resistance (IMR); latest 2029-09
Show the evidence
Trial
NCT03532399
"Pharmacokinetics of Bivalirudin for Pediatric Anticoagulation"; n 30; "Plasma Bivalirudin Concentration"; 2026-05
NCT03537586
"A Single Center Diagnostic, Cross-sectional Study of Coronary Microvascular Dysfunction"; n 206; "Platelet Activity measured by the Index of Microcirculatory Resistance (IMR)"; 2026-06-30
NCT04278404
"Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)"; n 5000; "Clearance (CL) or apparent oral clearance (CL/F) as measured by PK sampling"; 2026-12
NCT05959252
"BivaLirudin versUS Heparin in Extracorporeal Membrane Oxygenation"; n 80; "Time in therapeutic range"; 2026-09-01
NCT05984537
"A Study on the Impact of Bivalirudin Usage During PCI for High-risk Plaques on Post-PCI Coronary Microcirculation."; n 70; "CaIMR"; 2026-01-04
NCT06080074
"Multicenter Trial of ECMO in Children With Severe Cardiac Failure Using the Cardiohelp System"; n 50; "Survival to 30 days, recovery, ventricular assist device implant or transplant in the absence of severe symptomatic stroke (primary device effectiveness)"; 2029-09
2 further recorded trials
NCT06275555
"Use of Bivalirudin for Anticoagulation in Patients With Extracorporeal Membrane Oxygenation"; n 154; "thrombotic complications"; 2027-03-01
NCT06861374
"Bivalirudin with Prolonged Infusion During PCI Versus Heparin After Fibrinolytic Therapy"; n 2400; "Composite of all-cause death or BARC type 3、5 bleeding"; 2029-03
recorded 2026-09-01 · last checked 2026-09-04
Q9
Which running trial of Bivalirudin could settle lifespan?
NCT06080074 measures Survival to 30 days, recovery, ventricular assist device implant or transplant in the absence of severe symptomatic stroke (primary device effectiveness), reading out 2029-09.
1 open trial; n 50; "Multicenter Trial of ECMO in Children With Severe Cardiac Failure Using the Cardiohelp System"
Show the evidence
TrialNCT06080074
"Multicenter Trial of ECMO in Children With Severe Cardiac Failure Using the Cardiohelp System"; n 50; "Survival to 30 days, recovery, ventricular assist device implant or transplant in the absence of severe symptomatic stroke (primary device effectiveness)"; 2029-09
Q10
Which 16 trials of Bivalirudin posted no result?
Posted no result
16 of 16 completed trials
Registrations
NCT00079586, NCT00043277, NCT00290849, NCT00262054, NCT00448461 and NCT00503126, and 10 more
Completion dates
oldest 2004-11; newest 2023-05-06
Show the evidence
Trial
NCT00079586
2004-11
NCT00043277
2004-12
NCT00290849
2007-09
NCT00262054
2008-05
NCT00448461
2008-06
NCT00503126
2008-07
10 further recorded trials
NCT00373451
2011-07
NCT00616460
2011-10
NCT00812370
2013-07
NCT01465503
2013-12
NCT01696110
2014-07
NCT02311231
2017-03
NCT03588611
2021-06-26
NCT05334654
2022-07-30
NCT03664180
2022-11-23
NCT03822975
2023-05-06
Q11
At the median, Bivalirudin's trials enrolled 221 people — anything larger?
Median enrolment
221
Largest enrolment
6016
Registered trials counted
58
Q12
What do 731 spontaneous reports say about Bivalirudin — 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.
Bivalirudin appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 731 reaction mentions were counted: coronary artery thrombosis 135; thrombosis 123; coagulation time abnormal 101; haemorrhage 71. open-targets-adr · CHEMBL5314348 · 2026-06-24
Show the evidence
coronary artery thrombosis
135
thrombosis
123
coagulation time abnormal
101
haemorrhage
71
stent occlusion
67
chest pain
66
4 more recorded rows
heparin-induced thrombocytopenia
44
myocardial infarction
42
hypotension
41
international normalised ratio increased
41
recorded 2026-06-24 · last checked 2026-09-04
Where it is registeredIdentifiers, relations and other names
ChEMBL ATC CC BY-SA · 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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✓ public claims reviewed: 0 reviewed claim(s); drafts are never rendered
✓ source coverage passed: 8 source rows
✓ no critical contamination: no quarantine open
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