Angiomax in Patients With HIT/HITTS Type II Undergoing Off-Pump Coronary Artery Bypass Grafting (CABG) (CHOOSE)

PHASE3CompletedINTERVENTIONAL
Enrollment

88

Participants

Timeline

Start Date

October 31, 2003

Primary Completion Date

September 30, 2005

Conditions
ThrombocytopeniaThrombosisCardiac DiseaseCoronary Artery Bypass Surgery
Interventions
DRUG

Angiomax (bivalirudin) anticoagulant

): 250 mg vial administered as 0.75 mg/kg intravenous (IV) bolus and 1.75 mg/kg/h IV infusion for the duration of the procedure with the option to increase or decrease the infusion rate 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. A low-dose infusion could be administered in the preoperative phase (up to 48 hours before the procedure) and in the postoperative phase (up to 14 days after the procedure) as clinically indicated for management of HIT/TS. An initial dose of 0.1 mg/kg IV bolus followed by an IV infusion of 0.2 mg/kg/h titrated to a desired activated partial thromboplastin time (aPTT), eg, 1.5-2.5 times baseline aPTT, was recommended.

Trial Locations (1)

44195

The Cleveland Clinic, Cleveland

Sponsors
All Listed Sponsors
lead

The Medicines Company

INDUSTRY