Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| EVOLUTION |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bivalirudin | Experimental | 250mg vial given as 0.75mg/kg intravenous (IV) bolus and 1.75 mg/kg/hr IV infusion for the duration of the procedure with the option to increase or decrease the infusion in 0.25 mg/kg/hr increments or to administer additional 0.1-0.5 mg/kg boluses to maintain an ACT>300 seconds. |
|
| heparin/protamine | Active Comparator | 1.5-3.5 mg/kg (200-400 U/kg) intravenous (IV) bolus to target an ACT >300 seconds followed by weight-adjusted boluses as needed during the procedure to achieve/maintain the target ACT. Protamine as needed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bivalirudin | Drug | 250 mg vial administered as 0.75 mg/kg intravenous (IV) bolus and 1.75 mg/kg/h IV infusion for the duration of surgery with the option to increase or decrease the infusion in 0.25 mg/kg/h increments or to administer additional 0.1-0.5 mg/kg boluses to maintain an activated clotting time (ACT) >300 seconds (s). |
| Measure | Description | Time Frame |
|---|---|---|
| Death | Hospital discharge or Day 7 | |
| Q-wave MI | hospital discharge or day 7, | |
| Repeat Coronary Revascularization, | hospital discharge or day 7, | |
| Stroke (hemorrhagic or ischemic). | hospital discharge or day 7 |
Not provided
Not provided
Inclusion:
Exclusion:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Andrew Sternlicht, MD | The Medicines Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
Not provided
| ID | Term |
|---|---|
| C074619 | bivalirudin |
| D006493 | Heparin |
| D011479 | Protamines |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D009687 | Nuclear Proteins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Heparin | Drug | : Per institutional practice, at 1.5-3.5 mg/kg (200-400 U/kg) IV bolus to achieve a target ACT of >300 s followed by weight-adjusted boluses as needed during surgery to achieve/maintain the target ACT. Batches from hospital stock. |
|
| Protamine | Drug | Per institutional practice. Batches from hospital stock. |
|
| D011506 |
| Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009698 | Nucleoproteins |