Bivalirudin

Generic Name: Bivalirudin

Brand Names: Angiomax

Drug Type: Small Molecule

Chemical Formula: C_₉₈H_₁₃₈N_₂₄O_₃₃

CAS Number: 128270-60-0

Unique Ingredient Identifier: TN9BEX005G

Background: Bivalirudin is a synthetic 20 residue peptide (thrombin inhibitor) which reversibly inhibits thrombin. Once bound to the active site, thrombin cannot activate fibrinogen into fibrin, the crucial step in the formation of thrombus. It is administered intravenously. Because it can cause blood stagnation, it is important to monitor changes in hematocrit, activated partial thromboplastin time, international normalized ratio and blood pressure.

Indication: For treatment of heparin-induced thrombocytopenia and for the prevention of thrombosis. Bivalirudin is indicated for use in patients undergoing percutaneous coronary intervention (PCI), in patients at moderate to high risk acute coronary syndromes due to unstable angina or non-ST segment elevation in whom a PCI is planned.

Associated Conditions: Thrombosis

Clinical Trials

The UNBLOCK Study: Utilization of Bivalirudin On Clots in Kids

Phase 1

Completed

Conditions: Deep Venous Thrombosis

Interventions: Drug: Bivalirudin

First Posted Date: 2008-12-22

Last Posted Date: 2016-07-15

Lead Sponsor: Children's Hospital Los Angeles

Target Recruit Count: 18

Registration Number: NCT00812370

Locations: 🇺🇸
Baylor College of Medicine/Texas Children's Hospital, Houston, Texas, United States
🇺🇸
University of Texas Southwestern Medical Center at Dallas, Dallas, Texas, United States
🇺🇸
UCD Hemophilia & Thrombosis Center, Aurora, Colorado, United States

and more 3 locations

Bivalirudin PCI Registry in Heparin Induced Thrombocytopenia/Heparin Induced Thrombocytopenia and Thrombosis Syndrome (HIT/HITTS) Patients

Phase 4

Withdrawn

Conditions: Heparin-Induced Thrombocytopenia
Heparin-induced Thrombocytopenia and Thrombosis Syndrome

Interventions: Drug: bivalirudin

First Posted Date: 2008-09-25

Last Posted Date: 2020-10-19

Lead Sponsor: The Medicines Company

Registration Number: NCT00759083

Locations: 🇺🇸
Duke Clinical Research Institute, Durham, North Carolina, United States

Anticoagulant Treatments and Percutaneous Coronary Angioplasty

Phase 4

Terminated

Conditions: Coronary Artery Disease

Interventions: Drug: heparin + clopidogrel + aspirin
Drug: bivalirudin + clopidogrel + aspirin
Drug: clopidogrel + aspirin
Drug: enoxaparin + clopidogrel + aspirin

First Posted Date: 2008-04-29

Last Posted Date: 2019-05-17

Lead Sponsor: Centre Hospitalier de PAU

Target Recruit Count: 99

Registration Number: NCT00669149

Locations: 🇫🇷
Centre Hospitalier de Pau, PAU, Pyrénées-Atlantiques, France

ACRIPAB- Trial: Anti Coagulation Regimen In High Risk PAtients for Bleeding

Phase 3

Completed

Conditions: Hematologic Diseases

Interventions: Drug: Bivalirudin

First Posted Date: 2008-02-15

Last Posted Date: 2015-06-12

Lead Sponsor: HaEmek Medical Center, Israel

Target Recruit Count: 100

Registration Number: NCT00616460

Locations: 🇮🇱
Heart Institute haEmek Medical Center, Afula, Israel

Bivalirudin as a Procedural Anticoagulant in Pediatrics

Phase 2

Completed

Conditions: Cardiology

First Posted Date: 2007-07-18

Last Posted Date: 2011-11-10

Lead Sponsor: The Medicines Company

Target Recruit Count: 110

Registration Number: NCT00503126

Antithrombotic Regimens and Outcome

Phase 4

Completed

Conditions: Coronary Artery Disease

Interventions: Drug: heparin
Drug: bivalirudin

First Posted Date: 2007-03-16

Last Posted Date: 2009-02-10

Lead Sponsor: Careggi Hospital

Target Recruit Count: 850

Registration Number: NCT00448461

Locations: 🇮🇹
Division of Cardiology, Careggi Hospital, Florence, Italy

Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction

Phase 3

Completed

Conditions: Myocardial Infarction

Interventions: Device: Bare metal stent
Drug: Bivalirudin
Device: Paclitaxel-eluting stent
Drug: Unfractionated heparin

First Posted Date: 2007-02-12

Last Posted Date: 2017-12-04

Lead Sponsor: Cardiovascular Research Foundation, New York

Target Recruit Count: 3602

Registration Number: NCT00433966

Locations: 🇺🇸
LeBauer CV Research Foundation, Greensboro, North Carolina, United States

Randomized Comparison of Abciximab Plus Heparin With Bivalirudin in Acute Coronary Syndrome

Phase 4

Completed

Conditions: Coronary Disease
Myocardial Infarction

Interventions: Drug: Abciximab + UFH
Drug: Bivalirudin
Drug: Heparin

First Posted Date: 2006-09-08

Last Posted Date: 2012-05-08

Lead Sponsor: Deutsches Herzzentrum Muenchen

Target Recruit Count: 1721

Registration Number: NCT00373451

Locations: 🇩🇪
Medizinische Klinik, Klinikum rechts der Isar, Muenchen, Germany
🇩🇪
Herz-Zentrum Bad Krozingen, Bad Krozingen, Germany
🇩🇪
Herz- und Gefaessklinik, Kardiologie, Bad Neustadt, Germany

and more 6 locations