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Last Updated: May 27, 2022

CLINICAL TRIALS PROFILE FOR BIVALIRUDIN


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All Clinical Trials for Bivalirudin

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00043277 ↗ Study Of Angiomax In Infants Under Six Months With Thrombosis Completed The Medicines Company Phase 2 2002-08-01 The goals of this study are: 1. To assess the safety of bivalirudin in infants under six months with arterial or venous thrombosis; 2. To determine the dose of bivalirudin required to achieve adequate anticoagulation as measured by the activated clotting time (ACT) or activated partial thromboplastin time (aPTT) in Infants Under Six Months with arterial or venous thrombosis; 3. To determine the outcome of patients on bivalirudin with respect to thrombus resolution and bleeding complications compared to patients on unfractionated heparin (UH) or low molecular weight heparin (LMWH).
NCT00043940 ↗ Anticoagulant Therapy With Bivalirudin in the Performance of Percutaneous Coronary Intervention in Patients With Heparin-Induced Thrombocytopenia (AT BAT, First Inning) Completed The Medicines Company Phase 3 1999-04-01 Primary Objective: To assess the safety of bivalirudin as an alternative anticoagulant therapy for patients with new or previous heparin-induced thrombocytopenia (HIT) / heparin-induced thrombocytopenia and thrombosis syndrome (HITTS) undergoing percutaneous coronary intervention (PCI). This will be measured by the composite incidence of major bleeding events during administration or within 48 hours after stopping bivalirudin (or at hospital discharge, whichever occurs first). The components of the composite endpoint are: a) intracranial bleeding; b) retroperitoneal bleeding; c) bleeding that results in hemodynamic compromise; d) bleeding that requires transfusion of three or more units of whole blood or packed red cells; and e) a decrease in hemoglobin of greater than or equal to g/dL or in hematocrit of greater than or equal to 9%. Secondary Objectives: Each component of the primary composite endpoint. To evaluate the level of anticoagulation achieved with bivalirudin. The goal is to achieve an activated clotting time (ACT) between 300 and 350 sec during PCI and 4-hour bivalirudin infusion. To evaluate bivalirudin's effects on platelet counts.
NCT00073593 ↗ Comparing Angiomax to Heparin With Protamine Reversal in Patients OPCAB Completed The Medicines Company Phase 3 2003-08-01 The purpose of this study is to examine the safety and efficacy of Angiomax as an alternative anticoagulant to heparin with protamine reversal in patients undergoing off-pump coronary artery bypass graft surgery.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Bivalirudin

Condition Name

Condition Name for Bivalirudin
Intervention Trials
Coronary Artery Disease 11
Myocardial Infarction 7
Acute Coronary Syndrome 6
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Condition MeSH

Condition MeSH for Bivalirudin
Intervention Trials
Myocardial Infarction 21
Coronary Disease 20
Infarction 20
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Clinical Trial Locations for Bivalirudin

Trials by Country

Trials by Country for Bivalirudin
Location Trials
United States 62
China 33
Italy 12
Germany 11
Netherlands 5
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Trials by US State

Trials by US State for Bivalirudin
Location Trials
North Carolina 6
New York 6
Ohio 5
Maryland 4
California 4
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Clinical Trial Progress for Bivalirudin

Clinical Trial Phase

Clinical Trial Phase for Bivalirudin
Clinical Trial Phase Trials
Phase 4 35
Phase 3 21
Phase 2 3
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Clinical Trial Status

Clinical Trial Status for Bivalirudin
Clinical Trial Phase Trials
Completed 37
Unknown status 11
Terminated 8
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Clinical Trial Sponsors for Bivalirudin

Sponsor Name

Sponsor Name for Bivalirudin
Sponsor Trials
The Medicines Company 14
Deutsches Herzzentrum Muenchen 7
AstraZeneca 4
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Sponsor Type

Sponsor Type for Bivalirudin
Sponsor Trials
Other 84
Industry 29
NIH 1
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Serving leading biopharmaceutical companies globally:

AstraZeneca
Mallinckrodt
Harvard Business School
Medtronic
Johnson and Johnson
McKinsey

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