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| Sponsor: | The Medicines Company |
|---|---|
| Information provided by: | The Medicines Company |
| ClinicalTrials.gov Identifier: | NCT00079586 |
Purpose
The purpose of this study is to demonstrate that in patients undergoing coronary artery bypass grafting (CABG) or CABG-Valve, or Isolated Cardiac Valve surgery on CPB (cardiac surgery), Angiomax is a safe and effective alternative anticoagulant to heparin with protamine reversal.
| Condition | Intervention | Phase |
|---|---|---|
|
Cardiovascular Disease Coronary Artery Bypass Surgery |
Drug: Angiomax (bivalirudin) |
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 Cardiac Surgery on Cardiopulmonary Bypass (CPB) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
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.
Contacts and Locations
More Information
| Study ID Numbers: | TMC-BIV-02-06, EVOLUTION-On |
| Study First Received: | March 9, 2004 |
| Last Updated: | March 16, 2006 |
| ClinicalTrials.gov Identifier: | NCT00079586 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Anticoagulants Therapeutic Uses Bivalirudin |
Hematologic Agents Cardiovascular Diseases Pharmacologic Actions |