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).
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.
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.
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