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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Anticoagulant Therapy With Bivalirudin in the Performance of PCI in Patients With Heparin-Induced Thrombocytopenia

Brief Summary:

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.

Detailed Summary:
Sponsor: The Medicines Company

Current Primary Outcome: Major bleeding events [ Time Frame: 48 hours ]

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: The Medicines Company

Dates:
Date Received: August 14, 2002
Date Started: April 1999
Date Completion:
Last Updated: September 15, 2011
Last Verified: September 2011