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Home/Compounds/Bivalirudin
OtherFDA approvedRx required

Bivalirudin

Also known as: Angiomax · Angiox
Brands: Angiomax

Synthetic 20-amino-acid direct thrombin inhibitor used as an anticoagulant during PCI.

A
Grade A
Multiple human RCTs
Human studies29
PubMed citations29
Routeintravenous
Regulatory (US)FDA approved · Rx
Last verified2 days ago

Mechanism of action

Synthetic analog of hirudin. Reversible, direct, bivalent inhibitor of thrombin (binds both active site and exosite 1).

Evidence summary

29
Human studies
29
PubMed citations
25
Clinical trials
A
Evidence grade

Evidence summary in progress. See the citations section below for the underlying research papers.

Dosing protocols

Educational information only. Consult a licensed provider before using any peptide.
Administration routes
intravenous

Side effects & safety

No FDA label or editorial side-effect profile is on file for this compound yet. See the clinical trials and citations sections for study-reported safety data.

Interactions

No documented drug interactions on file.

Regulatory status

United States
FDA approved

FDA approved as an anticoagulant for patients undergoing PCI (Angiomax)

Compounding
Not permitted

Not available via 503A/503B compounding pharmacies.

Regulatory data last verified 4/19/2026

Clinical trials

NCT06275555Efficacy and Safety of Bivalirudin Versus Heparin in Anticoagulant Therapy of ECMO: a Randomized Controlled TrialRecruiting · N/A · Extracorporeal Membrane Oxygenation Complication · n=154NCT04278404Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied DrugsRecruiting · Coronavirus Infection (COVID-19) · n=5000NCT07383155Bivalirudin Versus Heparin During PCI in High Bleeding Risk Patients With Acute Coronary SyndromesNot Yet Recruiting · Phase 4 · Percutaneous Coronary Intervention · n=5270NCT06080074Multicenter Trial to Evaluate the Safety and Effectiveness of the Cardiohelp System for up to 30 Days of Support in Children With Severe Cardiac FailureRecruiting · Phase 2 · Heart Failure · n=50NCT03537586A Single Center Diagnostic, Cross-sectional Study of Coronary Microvascular DysfunctionActive Not Recruiting · N/A · Coronary Microvascular Disease · n=206NCT03822975Bivalirudin With Prolonged Full Dose Infusion Versus Heparin Alone During: a Multicenter, Randomized, Open-label TrialCompleted · N/A · ST Elevation Myocardial Infarction · n=6016NCT05984537A Study on the Impact of Bivalirudin Usage During Percutaneous Coronary Intervention for High-risk Plaques in the Coronary Artery on Post Percutaneous Coronary Intervention Coronary Microcirculation.Recruiting · Phase 4 · Coronary Microvascular Dysfunction · n=70NCT03532399Pharmacokinetics of Bivalirudin for Pediatric AnticoagulationRecruiting · Drug Effect · n=30NCT06861374Bivalirudin Plus High-Dose Infusion Versus Heparin Monotherapy in Patients with ST-Segment Elevation Myocardial Infarction Undergoing Percutaneous Coronary Intervention After Fibrinolysis: a Randomized TrialNot Yet Recruiting · N/A · ST-segment Elevation Myocardial Infarction (STEMI) · n=2400NCT05959252BivaLirudin versUS Heparin in ECMO - A Registry-embedded, Randomised, Open Label, Feasibility Trial Comparing Two Anticoagulation Strategies in Patients on Extracorporeal Membrane Oxygenation (ECMO)Recruiting · Phase 2 · Extracorporeal Membrane Oxygenation Complication · n=80NCT03664180Randomized Comparison of Anticoagulation After Primary Percutaneous Coronary Intervention Using Enoxaparin, ACT Guided Unfractionated Heparin or Bivalirudin Prolongation vs. no Anticoagulation To Improve Clinical OutcomeCompleted · Phase 4 · STEMI - ST Elevation Myocardial Infarction · n=2989NCT03318393Prospective Randomized Pilot Study Comparing Bivalirudin Versus Heparin in Neonatal and Pediatric Extracorporeal Membrane OxygenationCompleted · Phase 4 · Extracorporeal Membrane Oxygenation Complication · n=30

Showing 12 of 25 indexed studies. View all on ClinicalTrials.gov →

Citations

PMID 37959386Warkentin TE · Autoimmune Heparin-Induced Thrombocytopenia.Journal of clinical medicine (2024)HumanPMID 36194483Hasegawa D, Sato R et al. · Comparison of Bivalirudin Versus Heparin for Anticoagulation During Extracorporeal Membrane Oxygenation.ASAIO journal (American Society for Artificial Internal Organs : 1992) (2023)HumanPMID 37811688Raghavendran P, Tillman BF et al. · Chromogenic and Clot-Based Bivalirudin Assays for Monitoring Anticoagulation.The journal of applied laboratory medicine (2023)HumanPMID 36333207Burstein D, Kimmel S et al. · Cost-effectiveness of bivalirudin in pediatric ventricular assist devices.The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation (2023)HumanPMID 33736552Hvas AM, Favaloro EJ et al. · Heparin-induced thrombocytopenia: pathophysiology, diagnosis and treatment.Expert review of hematology (2022)HumanPMID 36351459Li Y, Liang Z et al. · Bivalirudin plus a high-dose infusion versus heparin monotherapy in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention: a randomised trial.Lancet (London, England) (2022)HumanPMID 32091668Kheiri B, Rao SV et al. · Meta-analysis of bivalirudin versus heparin in transradial coronary interventions.Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions (2021)HumanPMID 33857342Nilius H, Kaufmann J et al. · Comparative effectiveness and safety of anticoagulants for the treatment of heparin-induced thrombocytopenia.American journal of hematology (2021)HumanPMID 33225426Yacob O, Garcia-Garcia HM et al. · Impact of optical coherence tomography findings on clinical outcomes in ST-segment elevation myocardial infarction patients: a MATRIX (Minimizing Adverse Hemorrhagic Events by Trans-radial Access Site and angioX) OCT sub-study.The international journal of cardiovascular imaging (2021)HumanPMID 31883294Garcia-Garcia HM, Adamo M et al. · Assessment of residual thrombus burden in patients with ST-segment elevation myocardial infarction undergoing bivalirudin versus unfractionated heparin infusion: The MATRIX (minimizing adverse hemorrhagic events by transradial access site and angioX) OCT study.Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions (2021)HumanPMID 33174088Taylor T, Campbell CT et al. · A Review of Bivalirudin for Pediatric and Adult Mechanical Circulatory Support.American journal of cardiovascular drugs : drugs, devices, and other interventions (2021)HumanPMID 30920584Garcia-Garcia HM, Picchi A et al. · Comparison of intra-procedural vs. post-stenting prolonged bivalirudin infusion for residual thrombus burden in patients with ST-segment elevation myocardial infarction undergoing: the MATRIX (Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and angioX) OCT study.European heart journal. Cardiovascular Imaging (2021)HumanPMID 28891164Deliargyris EN, Kimmelstiel C · Heparin or bivalirudin for non-primary PCI: Beware of neat and simple answers….Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions (2019)HumanPMID 30719862Gilchrist IC · Heparin, bivalirudin, or the best of both for STEMI interventions.Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions (2019)HumanPMID 26642776Mastoris I, Dangas GD · Bivalirudin or Heparin Treatment During Transcatheter Valve Interventions: Where are we Now?Current pharmaceutical design (2016)HumanPMID 24337310Ahrens I, Bode C et al. · Anticoagulation during and after acute coronary syndrome.Hamostaseologie (2015)HumanPMID 25458646Valgimigli M · Design and rationale for the Minimizing Adverse haemorrhagic events by TRansradial access site and systemic Implementation of angioX program.American heart journal (2015)HumanPMID 26266343Li J, Yu S et al. · Bivalirudin Anticoagulant Therapy With or Without Platelet Glycoprotein IIb/IIIa Inhibitors During Transcatheter Coronary Interventional Procedures: A Meta-Analysis.Medicine (2015)HumanPMID 24395497Valgimigli M, Calabrò P et al. · Scientific foundation and possible implications for practice of the Minimizing Adverse Haemorrhagic Events by Transradial Access Site andSystemic Implementation of AngioX (MATRIX) trial.Journal of cardiovascular translational research (2014)HumanPMID 21974972De Luca G · Glycoprotein IIb-IIIa inhibitors.Cardiovascular therapeutics (2013)Human

Showing 20 of 29 papers. View all on PubMed →