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| Sponsor: | The Medicines Company |
|---|---|
| Information provided by (Responsible Party): | The Medicines Company |
| ClinicalTrials.gov Identifier: | NCT00079508 |
Purpose
The purpose of this study is to demonstrate that in patients with heparin-induced thrombocytopenia (HIT)/heparin-induced thrombocytopenia and thrombosis syndrome (HITTS) Type II undergoing cardiac surgery on cardiopulmonary bypass (CPB), Angiomax is a safe and effective anticoagulant.
| Condition | Intervention | Phase |
|---|---|---|
|
Cardiovascular Disease Coronary Artery Bypass Surgery |
Drug: Angiomax (bivalirudin) |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase III Study of Angiomax (Bivalirudin) in Patients With HIT/HITTS Type II Undergoing Cardiac Surgery on Cardiopulmonary Bypass (CPB) |
| Enrollment: | 125 |
| Study Start Date: | April 2004 |
| Primary Completion Date: | October 2005 (Final data collection date for primary outcome measure) |
An open-label, prospective, multicenter, single-arm study; with a historical reference cohort of similarly identified HIT/HITTS patients from participating institutions that underwent cardiac surgery on CPB with alternative anticoagulation regimens during the period of approximately 12 months prior to initiation of the first patient into this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
New diagnosis or history of objectively documented HIT/HITTS Type II, defined as one or more of the following:
Exclusion Criteria
Patients previously treated with warfarin may be enrolled if warfarin therapy can be safely discontinued and baseline INR is < 1.3 times control in the absence of heparin therapy.
Patients currently receiving lepirudin or argatroban can be enrolled if they are switched to Angiomax at least 24 hours prior to the planned cardiac surgery.
Contacts and Locations
More Information
| Responsible Party: | The Medicines Company |
| ClinicalTrials.gov Identifier: | NCT00079508 History of Changes |
| Other Study ID Numbers: | TMC-BIV-02-03, CHOOSE-On |
| Study First Received: | March 9, 2004 |
| Last Updated: | November 8, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Heparin-induced Thrombocytopenia Heparin-induced Thrombocytopenia/Thrombosis Syndrome HIT/HITTS Heparin anti-body positive |
|
Cardiovascular Diseases Bivalirudin Antithrombins Serine Proteinase Inhibitors Protease Inhibitors Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anticoagulants Hematologic Agents Therapeutic Uses |