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| ID | Type | Description | Link |
|---|---|---|---|
| EVOLUTION-On |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heparin | Active Comparator | unfractionated heparin will be administered as per institutional practice |
|
| Angiomax | Experimental | 1.0 mg/kg IV bolus followed by a 2.5 mg/kg/hr IV infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heparin | Drug | Unfractionated Heparin per institutional practice |
| |
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.
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| Name | Affiliation | Role |
|---|---|---|
| Malcolm Lloyd, MD | The Medicines Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D006493 | Heparin |
| C074619 | bivalirudin |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| Bivalirudin |
| Drug |
1.0 mg/kg IV bolus followed by a 2.5 mg/kg/hr IV infusion |
|