CLINICAL TRIALS PROFILE FOR BIVALIRUDIN IN 0.9% SODIUM CHLORIDE

All Clinical Trials for BIVALIRUDIN IN 0.9% SODIUM CHLORIDE

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.
NCT00079508 ↗	Angiomax in Patients With HIT/HITTS Type II Undergoing CPB	Completed	The Medicines Company	Phase 3	2004-04-01	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	2004-04-01	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	2003-08-01	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.

Clinical Trial Conditions for BIVALIRUDIN IN 0.9% SODIUM CHLORIDE

Condition Name

Condition Name for BIVALIRUDIN IN 0.9% SODIUM CHLORIDE
Intervention	Trials
Coronary Artery Disease	11
Myocardial Infarction	7
Acute Coronary Syndrome	6
Percutaneous Coronary Intervention	5

Condition MeSH

Condition MeSH for BIVALIRUDIN IN 0.9% SODIUM CHLORIDE
Intervention	Trials
Myocardial Infarction	21
Coronary Artery Disease	20
Infarction	20
Coronary Disease	20

Clinical Trial Locations for BIVALIRUDIN IN 0.9% SODIUM CHLORIDE

Trials by Country

Trials by Country for BIVALIRUDIN IN 0.9% SODIUM CHLORIDE
Location	Trials
United States	63
China	33
Italy	12
Germany	11
Netherlands	5

Trials by US State

Trials by US State for BIVALIRUDIN IN 0.9% SODIUM CHLORIDE
Location	Trials
New York	7
North Carolina	6
Ohio	5
Maryland	4
California	4

Clinical Trial Progress for BIVALIRUDIN IN 0.9% SODIUM CHLORIDE

Clinical Trial Phase

Clinical Trial Phase for BIVALIRUDIN IN 0.9% SODIUM CHLORIDE
Clinical Trial Phase	Trials
Phase 4	35
Phase 3	21
Phase 2	5

Clinical Trial Status

Clinical Trial Status for BIVALIRUDIN IN 0.9% SODIUM CHLORIDE
Clinical Trial Phase	Trials
Completed	37
Unknown status	11
Terminated	8

Clinical Trial Sponsors for BIVALIRUDIN IN 0.9% SODIUM CHLORIDE

Sponsor Name

Sponsor Name for BIVALIRUDIN IN 0.9% SODIUM CHLORIDE
Sponsor	Trials
The Medicines Company	14
Deutsches Herzzentrum Muenchen	7
AstraZeneca	4

Sponsor Type

Sponsor Type for BIVALIRUDIN IN 0.9% SODIUM CHLORIDE
Sponsor	Trials
Other	86
Industry	30
NIH	1