The Effect Of Acadesine On Reducing Cardiovascular and Cerebrovascular Adverse Events In Coronary Artery Bypass Graft (CABG) Surgery (Study P05633 AM1)(TERMINATED)

PHASE3TerminatedINTERVENTIONAL
Enrollment

3,080

Participants

Timeline

Start Date

April 30, 2009

Primary Completion Date

October 31, 2010

Study Completion Date

October 31, 2010

Conditions
Coronary Artery BypassMyocardial InfarctionVentricular Dysfunction, LeftStrokeCardiopulmonary Bypass
Interventions
DRUG

Acadesine

Acadesine 42 mg/kg diluted in normal saline to a total of 500 mL, delivered as an IV infusion over approximately 7 hours commencing within approximately 30 minutes before induction of anesthesia at a rate of 0.1 mg/kg/min (translating into 1.2 mL/min for a 500 mL solution). In addition, a 5 µg/mL cardioplegia solution of acadesine will be administered, and acadesine will be added to the priming solution (5 µg/mL) in the heart lung machine during CPB.

DRUG

Normal Saline

Normal saline, 500 mL delivered as an IV infusion over approximately 7 hours commencing within approximately 30 minutes before induction of anesthesia at a rate of 1.2 mL/min for a 500 mL solution. In addition, standard cardioplegia solution with added normal saline will be administered, and placebo (normal saline) will also be added to the heart lung machine priming solution.

Sponsors
All Listed Sponsors
collaborator

Duke Clinical Research Institute

OTHER

lead

Merck Sharp & Dohme LLC

INDUSTRY