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

Phase 3

Completed

• Conditions: Heparin-Induced Thrombocytopenia; Thrombosis

• Registration Number: NCT00043940
• Lead Sponsor: The Medicines Company

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 Description

Not available

Study Timeline

• Study Start: 1999-04
• Study First Submitted: 2002-08-14
• Study First Submitted QC: 2002-08-15
• Study First Posted: 2002-08-16
• Primary Completion: 2003-02
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-15
• Last Update Posted: 2011-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Major bleeding events	48 hours	composite incidence of major bleeding events during administration or within 48 hours after stopping bivalirudin

Trial Locations

Locations (1)

Duke Clinical Research Institute, Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States