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Sponsored by: |
The Medicines Company |
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Information provided by: | The Medicines Company |
ClinicalTrials.gov Identifier: | NCT00073593 |
The purpose of this study is to examine the safety and efficacy of Angiomax as an alternative anticoagulant to heparin with protamine reversal in patients undergoing off-pump coronary artery bypass graft surgery.
Condition | Intervention | Phase |
---|---|---|
Cardiac Surgery Coronary Artery Bypass Surgery |
Drug: Angiomax (bivalirudin) anticoagulant |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Study Comparing Angiomax (Bivalirudin) to Heparin With Protamine Reversal in Patients Undergoing Coronary Artery Bypass (OPCAB) Surgery |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion:
Exclusion:
Study ID Numbers: | TMC-BIV-02-07, EVOLUTION |
Study First Received: | November 26, 2003 |
Last Updated: | November 9, 2005 |
ClinicalTrials.gov Identifier: | NCT00073593 |
Health Authority: | United States: Food and Drug Administration |
Off-Pump Coronary Artery Bypass Graft Surgery CABG OPCAB Heparin Patients requiring off-pump CABG |
Bivalirudin Protamines Heparin Calcium heparin |
Fibrin Modulating Agents Anticoagulants Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Hematologic Agents Fibrinolytic Agents Cardiovascular Agents Pharmacologic Actions |