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Sponsored by: |
The Medicines Company |
---|---|
Information provided by: | The Medicines Company |
ClinicalTrials.gov Identifier: | NCT00043940 |
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.
Condition | Intervention | Phase |
---|---|---|
Heparin-Induced Thrombocytopenia Thrombosis |
Drug: bivalirudin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Anticoagulant Therapy With Bivalirudin in the Performance of PCI in Patients With Heparin-Induced Thrombocytopenia |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
INCLUSION:
(A) Positive heparin-induced platelet aggregation (HIPA) or other functional assay, defined as: (B) HIT: Thrombocytopenia associated with heparin therapy, where the platelet count: (i) has decreased to <100x10(9)/L (minimum of 30% drop from the platelet count before heparin treatment), OR (ii) has decreased to <150x10(9)/L (minimum of 40% drop from the platelet count before heparin treatment, OR, (C) HITTS: Thrombocytopenia (as defined above) PLUS arterial or venous thrombosis (deep-vein thrombosis, pulmonary embolism, mesenteric venous or arterial thrombosis, acute myocardial infarction, left ventricular thrombus, ischemic stroke, or occlusion or limb arteries), diagnosed by physical exam/lab evidence and/or appropriate imaging studies (duplex ultrasound, venography, ventilation-perfusion scan, venous or arterial angiography, MRI/MRA, catheterization).
EXCLUSION:
Study ID Numbers: | TMC-98-10 |
Study First Received: | August 14, 2002 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00043940 |
Health Authority: | United States: Food and Drug Administration |
thrombosis bivalirudin direct thrombin inhibitor |
HIT HITTS HIT/HITTS |
Thrombin Hematologic Diseases Blood Platelet Disorders Vascular Diseases Thrombosis Calcium heparin Thrombocytopathy |
Embolism and Thrombosis Thrombocytopenia Embolism Heparin-induced thrombocytopenia Bivalirudin Heparin |
Anticoagulants Therapeutic Uses Hematologic Agents Cardiovascular Diseases Pharmacologic Actions |