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| Sponsored by: |
The Medicines Company |
| Information provided by: | 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 |
| ChemIDplus related topics: | Heparin Bivalirudin |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Phase III Study of Angiomax (Bivalirudin) in Patients With HIT/HITTS Type II Undergoing Cardiac Surgery on Cardiopulmonary Bypass (CPB) |
| Estimated Enrollment: | 50 |
| Study Start Date: | April 2004 |
An open-label, prospective, multicenter, single-arm study; with a historical reference cohort of similarly identified HIT/HITTS patients from participating institutions that underwent cardiac surgery on CPB with alternative anticoagulation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
| Study ID Numbers: | TMC-BIV-02-03, CHOOSE-On |
| First Received: | March 9, 2004 |
| Last Updated: | March 16, 2006 |
| ClinicalTrials.gov Identifier: | NCT00079508 |
| Health Authority: | United States: Food and Drug Administration |
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