Thrombosis Clinical Trial
Official title:
Anticoagulant Therapy With Bivalirudin in the Performance of PCI in Patients With Heparin-Induced Thrombocytopenia
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.
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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