Evidence review: Open Peptide Project (verified against primary PubMed, ClinicalTrials.gov & FDA records) · Last checked 2026-10-27. ← Back to Evidence Library
Bivalirudin (Angiomax): what the evidence says
At a glance
What it is: a 20-amino-acid synthetic direct thrombin inhibitor modeled on leech hirudin, given IV during coronary angioplasty (PCI). FDA-approved as Angiomax. R1 UNVERIFIED the residue count against the label.
What the evidence says: in REPLACE-2 (6,010 patients) it was non-inferior to heparin plus a GP IIb/IIIa blocker for ischemic events with less major bleeding (2.4% vs 4.1%). R2 In HORIZONS-AMI (3,602 heart-attack patients) it lowered 30-day major bleeding and cardiac death. R3, R4
Biggest risks: bleeding, as with any anticoagulant. HORIZONS-AMI reported early stent thrombosis; see the trial. R3 UNVERIFIED the stent-thrombosis figures; they were cut from the abstract text we read.
Rating
| Human Human evidence | Strong: REPLACE-2 (n = 6,010), HORIZONS-AMI (n = 3,602) R2, R3 |
| Animal Animal / lab evidence | Not reviewed |
| Regulatory | FDA-approved R1 · not on FDA's 503A or 503B bulk-substance category lists and not on FDA's compounding safety-risk page R5, R6, R7 · not named by WADA R8 |
| Established human dose | Yes, label dose (see Study details) |
Evidence verdict: Anticoagulation during PCI: Strong (FDA-approved; large RCTs, less bleeding than heparin + GP IIb/IIIa)
This page reports what studies used. It is not dosing advice.
Legend: HUMAN data · ANIMAL / LAB data · UNKNOWN · UNVERIFIED: not yet confirmed against a primary source
About the evidence: two large randomized trials support its use during PCI. It is a hospital-only drug with no role outside a cath lab.
What is it?
Related pages: Ziconotide, Exenatide.
Does it work?
- Human REPLACE-2: non-inferior for ischemic events; less bleeding. R2
- Human HORIZONS-AMI: cardiac death 1.8% vs 2.9% at 30 days. R3
Is it safe?
- Human Less major bleeding than heparin plus GP IIb/IIIa in both trials. R2, R3
Gray-market vials: extra risks
A gray-market vial has no quality control and no guarantee of identity, strength or sterility. We test retail vials blind under the Open Peptide Standard; see /tests/. A passing test covers one batch on one date and does not mean the compound is safe.
Is it legal?
- US: FDA-approved, prescription (hospital use). R1
- Compounding: not on FDA's 503A or 503B bulk-substance category lists and not on FDA's compounding safety-risk page. R5, R6, R7
- Sport: not named on WADA's 2026 Prohibited List. R8
Study details
Study details
These are amounts researchers used, not recommendations.
| Study | People / model | Route | Amount used | Follow-up | Reported | Citation |
|---|---|---|---|---|---|---|
| REPLACE-2 2003 | 6,010 PCI patients | IV | 0.75 mg/kg bolus + 1.75 mg/kg/h | In-hospital/30 days | Non-inferior; bleeding 2.4% vs 4.1% | PMID 12588269 |
| HORIZONS-AMI 2008 | 3,602 STEMI, primary PCI | IV | Per study | 30 days | Cardiac death 1.8% vs 2.9% | PMID 18499566 |
Full reference list (PubMed, CT.gov, FDA and WADA checked Oct 26, 2026)
- R1 Drugs@FDA, Angiomax (bivalirudin), application NDA020873 (openFDA drugsfda record checked Oct 26, 2026). https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=NDA020873
- R2 Lincoff AM, et al. JAMA. 2003. PMID 12588269
- R3 Stone GW, et al. N Engl J Med. 2008. PMID 18499566
- R4 ClinicalTrials.gov NCT00433966, HORIZONS-AMI (CT.gov API v2, checked Oct 26, 2026). https://clinicaltrials.gov/study/NCT00433966
- R5 FDA, 503A bulk drug substances categories list (updated May 14, 2026). https://www.fda.gov/media/94155/download
- R6 FDA, 503B bulk drug substances categories list (updated Mar 21, 2025). https://www.fda.gov/media/94164/download
- R7 FDA, Certain bulk drug substances for use in compounding that may present significant safety risks (content current Apr 22, 2026). https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
- R8 WADA. The 2026 Prohibited List, full list checked; compound not named. https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf
Disclaimer
This page is for education and harm reduction, not medical advice or a recommendation to use Bivalirudin (Angiomax). This is a prescription medicine. Use it only under the care of a licensed clinician; do not buy it from research-chemical or gray-market sellers. Report problems to FDA MedWatch (https://www.fda.gov/safety/medwatch).