Comparing Angiomax to Heparin With Protamine Reversal in Patients OPCAB

PHASE3CompletedINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

August 31, 2003

Primary Completion Date

May 31, 2004

Conditions
Cardiac SurgeryCoronary Artery Bypass Surgery
Interventions
DRUG

Bivalirudin

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).

DRUG

Heparin

: 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.

DRUG

Protamine

Per institutional practice. Batches from hospital stock.

Trial Locations (1)

44195

Cleveland Clinic Foundation, Cleveland

Sponsors
All Listed Sponsors
lead

The Medicines Company

INDUSTRY