MedPath

Bivalirudin

Generic Name
Bivalirudin
Brand Names
Angiomax
Drug Type
Small Molecule
Chemical Formula
C98H138N24O33
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

A Study To Determine the Efficacy and Safety of REG1 Compared to Bivalirudin in Patients Undergoing PCI

Phase 3
Terminated
Conditions
Coronary Artery Disease
Interventions
Drug: pegnivacogin/anivamersen
First Posted Date
2013-05-07
Last Posted Date
2014-10-23
Lead Sponsor
Regado Biosciences, Inc.
Target Recruit Count
3232
Registration Number
NCT01848106
Locations
🇺🇸

Black Hills Cardiovascular Research, Rapid City, South Dakota, United States

BivaliRudin in Acute Myocardial Infarction vs Glycoprotein IIb/IIIa and Heparin :a Randomised Controlled Trial.

Phase 4
Completed
Conditions
Percutaneous Coronary Intervention
Acute Myocardial Infarction
Interventions
First Posted Date
2012-09-28
Last Posted Date
2014-10-01
Lead Sponsor
Shenyang Northern Hospital
Target Recruit Count
2194
Registration Number
NCT01696110
Locations
🇨🇳

1 st Hosp. of Anhui Med Univ., Hefei, Anhui, China

🇨🇳

Anhui Provincial Hosp., Hefei, Anhui, China

🇨🇳

3rd Hosp. of Beijing Univ., Beijing, Beijing, China

and more 78 locations

Open-label, Randomized Trial in Participants Undergoing TAVR to Determine Safety & Efficacy of Bivalirudin vs UFH

Phase 3
Completed
Conditions
Transcatheter Aortic Valve Replacement
Aortic Valve Replacement
Severe Aortic Stenosis
Interventions
First Posted Date
2012-07-27
Last Posted Date
2017-04-07
Lead Sponsor
The Medicines Company
Target Recruit Count
803
Registration Number
NCT01651780
Locations
🇨🇦

Montreal Heart Institute, Montreal, Quebec, Canada

🇨🇦

St. Paul´s Hospital Providence Health Care, Vancouver, Canada

🇫🇷

Centre Hospitalier de Lyon, Bron, France

and more 30 locations

Bivalirudin Plus Stenting in Long Lesion to Avoid Periprocedural Myocardial Necrosis Trial

Phase 3
Conditions
Coronary Artery Disease
Interventions
First Posted Date
2012-03-15
Last Posted Date
2012-03-15
Lead Sponsor
University of Roma La Sapienza
Target Recruit Count
204
Registration Number
NCT01555658
Locations
🇮🇹

Dept.of Cardiovascular Sciences Policlinico Umberto I, Rome, Italy

How Effective Are Antithrombotic Therapies in Primary Percutaneous Coronary Intervention

Phase 4
Completed
Conditions
Acute ST Elevation Myocardial Infarction
Interventions
First Posted Date
2012-01-27
Last Posted Date
2015-05-13
Lead Sponsor
Liverpool Heart and Chest Hospital NHS Foundation Trust
Target Recruit Count
1829
Registration Number
NCT01519518
Locations
🇬🇧

Liverpool Heart and Chest Hospital, Liverpool, Merseyside, United Kingdom

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

Phase 3
Completed
Conditions
Bleeding
Interventions
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
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
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
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
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

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