Comparing Angiomax to Heparin With Protamine Reversal in Patients OPCAB (OPCAB)
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|ClinicalTrials.gov Identifier: NCT00073593|
Recruitment Status : Completed
First Posted : November 27, 2003
Last Update Posted : November 10, 2011
|Condition or disease||Intervention/treatment||Phase|
|Cardiac Surgery Coronary Artery Bypass Surgery||Drug: Bivalirudin Drug: Heparin Drug: Protamine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study Comparing Angiomax (Bivalirudin) to Heparin With Protamine Reversal in Patients Undergoing Coronary Artery Bypass (OPCAB) Surgery|
|Study Start Date :||August 2003|
|Actual Primary Completion Date :||May 2004|
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.
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).
Active Comparator: heparin/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
: 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.
Per institutional practice. Batches from hospital stock.
- Death [ Time Frame: Hospital discharge or Day 7 ]
- Q-wave MI [ Time Frame: hospital discharge or day 7, ]
- Repeat Coronary Revascularization, [ Time Frame: hospital discharge or day 7, ]
- Stroke (hemorrhagic or ischemic). [ Time Frame: hospital discharge or day 7 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00073593
|United States, Ohio|
|Cleveland Clinic Foundation|
|Cleveland, Ohio, United States, 44195|
|Study Director:||Andrew Sternlicht, MD||The Medicines Company|