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, activat...

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

Associated Therapies: -

Clinical Trials

Novel Approaches in Preventing and Limiting Events III Trial (NAPLES III): Bivalirudin in High-risk Bleeding Patients

Phase 3

Completed

Conditions: Bleeding

Interventions: Drug: Unfractionated Heparin
Drug: Bivalirudin

First Posted Date: 2011-11-04

Last Posted Date: 2014-04-08

Lead Sponsor: Clinica Mediterranea

Target Recruit Count: 837

Registration Number: NCT01465503

Locations: 🇮🇹
IRCCS Policlinico Multimedica, Milan, Italy
🇮🇹
Clinica Mediterranea, Naples, Italy

Angiomax® or Unfractionated Heparin for Patients Undergoing Percutaneous Coronary Intervention

Phase 4

Terminated

Conditions: Coronary Artery Disease

Interventions: Drug: Heparin
Drug: Bivalirudin

First Posted Date: 2011-11-03

Last Posted Date: 2014-11-20

Lead Sponsor: Stony Brook University

Target Recruit Count: 260

Registration Number: NCT01464671

Locations: 🇺🇸
Stony Brook University Medical Center, Stony Brook, New York, United States

European Ambulance Acute Coronary Syndrome (ACS) Angiography Trial

Phase 3

Completed

Conditions: Acute Coronary Syndrome

Interventions: Drug: Bivalirudin
Drug: Heparin

First Posted Date: 2010-03-16

Last Posted Date: 2016-02-12

Lead Sponsor: The Medicines Company

Target Recruit Count: 2198

Registration Number: NCT01087723

Locations: 🇦🇹
Magistratsabeilung 70, Wiener, Wien, Austria
🇦🇹
Universitats-Klinik Fur, Wien, Austria
🇩🇰
Odense Universitets Hospital, Odense, Denmark

and more 142 locations

EArly Discharge After Transradial Stenting of CoronarY Arteries in High-Risk Patients of Bleeding

Phase 4

Conditions: Coronary Artery Disease

Interventions: Drug: Bivalirudin
Drug: Heparin

First Posted Date: 2010-03-11

Last Posted Date: 2018-01-31

Lead Sponsor: Laval University

Target Recruit Count: 2000

Registration Number: NCT01084993

Locations: 🇨🇦
Quebec Heart-Lung Institute, Quebec, Canada

Efficacy Study of Combined Prasugrel and Bivalirudin Versus Clopidogrel and Heparin in Myocardial Infarction

Phase 4

Conditions: Myocardial Infarction

Interventions: Drug: Prasugrel
Drug: Clopidogrel
Drug: Bivalirudin
Drug: Heparin

First Posted Date: 2009-09-14

Last Posted Date: 2014-01-07

Lead Sponsor: Deutsches Herzzentrum Muenchen

Target Recruit Count: 548

Registration Number: NCT00976092

Locations: 🇩🇪
Deutsches Herzzentrum Muenchen, Munich, Bavaria, Germany
🇩🇪
Klinikum rechts der Isar, Technische Universitaet Muenchen, Munich, Bavaria, Germany
🇩🇪
Herzzentrum der Segeberger Kliniken, Bad Segeberg, Germany

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

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

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