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

ImproveR International (BI-001-IM)

Completed
Conditions
Thrombin-specific Anticoagulant Bivalirudin During Percutaneous Coronary Intervention (PCI)
First Posted Date
2006-02-13
Last Posted Date
2012-05-07
Lead Sponsor
Nycomed
Target Recruit Count
4000
Registration Number
NCT00290849
Locations
🇩🇰

Nycomed, Roskilde, Denmark

Un-fractionated Heparin Versus Bivalirudin During Percutaneous Coronary Interventions (PCI) (ISAR-REACT-3)

Phase 4
Completed
Conditions
Coronary Disease
Angina Pectoris
Interventions
First Posted Date
2005-12-06
Last Posted Date
2010-03-15
Lead Sponsor
Deutsches Herzzentrum Muenchen
Target Recruit Count
4570
Registration Number
NCT00262054
Locations
🇩🇪

First Medizinische Klinik, Klinikum rechts der Isar, Munich, Germany

🇩🇪

Herz-Zentrum, Bad Krozingen, Germany

🇩🇪

Segeberger Kliniken, Bad Segeberg, Germany

and more 1 locations

Comparison of Angiomax Versus Heparin in Acute Coronary Syndromes (ACS)

Phase 3
Completed
Conditions
Unstable Angina
Myocardial Infarction
Acute Disease
First Posted Date
2004-10-07
Last Posted Date
2007-08-21
Lead Sponsor
The Medicines Company
Target Recruit Count
13800
Registration Number
NCT00093158
Locations
🇺🇸

Cardiovascular Research Foundation, New York, New York, United States

Bivalirudin in Patients With Acute Myocardial Infarction (AMI) Undergoing Primary PCI

Phase 3
Completed
Conditions
Myocardial Infarction
First Posted Date
2004-10-07
Last Posted Date
2006-02-09
Lead Sponsor
The Medicines Company
Target Recruit Count
300
Registration Number
NCT00093184
Locations
🇺🇸

The Heart Care Research Foundation, Blue Island, Illinois, United States

Comparing Angiomax to Heparin With Protamine in Patients Undergoing Cardiopulmonary Bypass (CPB)

Phase 3
Completed
Conditions
Cardiovascular Disease
Coronary Artery Bypass Surgery
Interventions
First Posted Date
2004-03-11
Last Posted Date
2012-01-05
Lead Sponsor
The Medicines Company
Target Recruit Count
150
Registration Number
NCT00079586
Locations
🇺🇸

The Cleveland Clinic, Cleveland, Ohio, United States

Angiomax in Patients With HIT/HITTS Type II Undergoing CPB

Phase 3
Completed
Conditions
Cardiovascular Disease
Coronary Artery Bypass Surgery
First Posted Date
2004-03-11
Last Posted Date
2011-11-10
Lead Sponsor
The Medicines Company
Target Recruit Count
125
Registration Number
NCT00079508
Locations
🇺🇸

The Cleveland Clinic, Cleveland, Ohio, United States

Comparing Angiomax to Heparin With Protamine Reversal in Patients OPCAB

Phase 3
Completed
Conditions
Cardiac Surgery
Coronary Artery Bypass Surgery
Interventions
First Posted Date
2003-11-27
Last Posted Date
2011-11-10
Lead Sponsor
The Medicines Company
Target Recruit Count
150
Registration Number
NCT00073593
Locations
🇺🇸

Cleveland Clinic Foundation, Cleveland, Ohio, United States

Angiomax in Patients With HIT/HITTS Type II Undergoing Off-Pump Coronary Artery Bypass Grafting (CABG) (CHOOSE)

Phase 3
Completed
Conditions
Thrombocytopenia
Cardiac Disease
Thrombosis
Coronary Artery Bypass Surgery
First Posted Date
2003-11-27
Last Posted Date
2018-11-30
Lead Sponsor
The Medicines Company
Target Recruit Count
88
Registration Number
NCT00073580
Locations
🇺🇸

The Cleveland Clinic, Cleveland, Ohio, United States

Anticoagulant Therapy With Bivalirudin in the Performance of Percutaneous Coronary Intervention in Patients With Heparin-Induced Thrombocytopenia (AT BAT, First Inning)

Phase 3
Completed
Conditions
Heparin-Induced Thrombocytopenia
Thrombosis
First Posted Date
2002-08-16
Last Posted Date
2011-09-16
Lead Sponsor
The Medicines Company
Target Recruit Count
50
Registration Number
NCT00043940
Locations
🇺🇸

Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina, United States

Study Of Angiomax In Infants Under Six Months With Thrombosis

Phase 2
Completed
Conditions
Thrombosis
First Posted Date
2002-08-08
Last Posted Date
2006-02-01
Lead Sponsor
The Medicines Company
Target Recruit Count
25
Registration Number
NCT00043277
Locations
🇺🇸

Children's Hospital of Orange County, Orange, California, United States

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