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Generated: December 18, 2018

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CLINICAL TRIALS PROFILE FOR BIVALIRUDIN

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Clinical Trials for Bivalirudin

Trial ID Title Status Sponsor Phase Summary
NCT00043277 Study Of Angiomax In Infants Under Six Months With Thrombosis Completed The Medicines Company Phase 2 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 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 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.
NCT00079508 Angiomax in Patients With HIT/HITTS Type II Undergoing CPB Completed The Medicines Company Phase 3 The purpose of this study is to demonstrate that in patients with heparin-induced thrombocytopenia (HIT)/heparin-induced thrombocytopenia and thrombosis syndrome (HITTS) Type II undergoing cardiac surgery on cardiopulmonary bypass (CPB), Angiomax is a safe and effective anticoagulant.
NCT00079586 Comparing Angiomax to Heparin With Protamine in Patients Undergoing Cardiopulmonary Bypass (CPB) Completed The Medicines Company Phase 3 The purpose of this study is to demonstrate that in patients undergoing coronary artery bypass grafting (CABG) or CABG-Valve, or Isolated Cardiac Valve surgery on CPB (cardiac surgery), Angiomax is a safe and effective alternative anticoagulant to heparin with protamine reversal.
NCT00093158 Comparison of Angiomax Versus Heparin in Acute Coronary Syndromes (ACS) Completed The Medicines Company Phase 3 The purpose of this study is to show that, when compared with heparin (enoxaparin or unfractionated heparin) and routine GPIIb/IIIa inhibition (either started upfront or at the time of percutaneous coronary intervention [PCI]; Arm A): 1. Bivalirudin with routine GPIIb/IIIa inhibition (either started upfront or at the time of PCI; Arm B) provides non-inferior or superior overall clinical outcomes and 2. Bivalirudin alone (Arm C) reduces clinically significant bleeding. An important secondary objective for this comparison is to show that bivalirudin is not inferior for ischemic complications.
NCT00093184 Bivalirudin in Patients With Acute Myocardial Infarction (AMI) Undergoing Primary PCI Completed The Medicines Company Phase 3 The purpose of this study is to demonstrate the benefit of bivalirudin in combination with clopidogrel with provisional GPIIb/IIIa inhibitor use, in reducing the bleeding complications associated with early invasive management of patients presenting with an ST Elevation Myocardial Infarction (STEMI) and undergoing primary PCI, while providing similar rates of ischemic events when compared to published results of relevant trials.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Bivalirudin

Condition Name

Condition Name for Bivalirudin
Intervention Trials
Coronary Artery Disease 10
Myocardial Infarction 7
Acute Coronary Syndrome 5
Atrial Fibrillation 3
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Condition MeSH

Condition MeSH for Bivalirudin
Intervention Trials
Myocardial Infarction 18
Infarction 17
Coronary Disease 16
Coronary Artery Disease 16
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Clinical Trial Locations for Bivalirudin

Trials by Country

Trials by Country for Bivalirudin
Location Trials
United States 61
China 26
Italy 11
Germany 10
Netherlands 5
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Trials by US State

Trials by US State for Bivalirudin
Location Trials
New York 6
North Carolina 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 28
Phase 3 19
Phase 2 4
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Clinical Trial Status

Clinical Trial Status for Bivalirudin
Clinical Trial Phase Trials
Completed 32
Not yet recruiting 6
Terminated 5
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Clinical Trial Sponsors for Bivalirudin

Sponsor Name

Sponsor Name for Bivalirudin
Sponsor Trials
The Medicines Company 14
Deutsches Herzzentrum Muenchen 6
AstraZeneca 4
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Sponsor Type

Sponsor Type for Bivalirudin
Sponsor Trials
Other 55
Industry 28
NIH 1
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