Angiomax in Patients With HIT/HITTS Type II Undergoing CPB

PHASE3CompletedINTERVENTIONAL
Enrollment

125

Participants

Timeline

Start Date

April 30, 2004

Primary Completion Date

October 31, 2005

Conditions
Cardiovascular DiseaseCoronary Artery Bypass Surgery
Interventions
DRUG

Angiomax (bivalirudin)

250 mg vial administered as 1.0 mg/kg intravenous (IV) bolus and 2.5 mg/kg/h IV infusion during the procedure with the option to administer additional 0.1 to 0.5 mg/kg boluses to increase the level of anticoagulation as clinically indicated. A low-dose infusion could have been 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. A starting bolus of 0.1 mg/kg and/or an 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

NCT00079508 - Angiomax in Patients With HIT/HITTS Type II Undergoing CPB | Biotech Hunter | Biotech Hunter