Comparing Angiomax to Heparin With Protamine Reversal in Patients OPCAB
Phase 3
Completed
- Conditions
- Cardiac SurgeryCoronary Artery Bypass Surgery
- Interventions
- Registration Number
- NCT00073593
- Lead Sponsor
- The Medicines Company
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description bivalirudin Bivalirudin 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 Heparin 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 heparin/protamine Protamine 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
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States