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| Sponsored by: |
The Medicines Company |
|---|---|
| Information provided by: | The Medicines Company |
| ClinicalTrials.gov Identifier: | NCT00073593 |
Purpose
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 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion:
Exclusion:
Contacts and Locations
More Information
| Study ID Numbers: | TMC-BIV-02-07, EVOLUTION |
| Study First Received: | November 26, 2003 |
| Last Updated: | November 9, 2005 |
| ClinicalTrials.gov Identifier: | NCT00073593 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Off-Pump Coronary Artery Bypass Graft Surgery CABG OPCAB Heparin Patients requiring off-pump CABG |
|
Fibrin Modulating Agents Anticoagulants Bivalirudin Fibrinolytic Agents |
Cardiovascular Agents Protamines Heparin Calcium heparin |
|
Fibrin Modulating Agents Anticoagulants Molecular Mechanisms of Pharmacological Action Therapeutic Uses Bivalirudin |
Hematologic Agents Fibrinolytic Agents Cardiovascular Agents Heparin Pharmacologic Actions |