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

Terminated

Phase 3 Results

Trial Description

The purpose of this study is to determine whether acadesine is effective in reducing the cardiovascular and cerebrovascular adverse events in high-risk participants undergoing CABG surgery.

Conditions

Interventions

  • Acadesine Drug
    Other Names: SCH 900395
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Acadesine
    Description: Acadesine IV infusion, plus cardioplegia solution with acadesine, and priming solution with acadesine in the heart lung machine during cardiopulmonary bypass (CPB)
  • Normal Saline Drug
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Placebo (normal saline)
    Description: Placebo (normal saline) IV infusion, plus cardioplegia solution with added normal saline, and priming solution with added normal saline in the heart lung machine during CPB
    ARM 2: Kind: Experimental
    Label: Placebo
    Description: Normal saline, IV infusion, plus cardioplegia solution with added normal saline, and priming solution with added normal saline in the heart lung machine during CPB

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Prevention
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary The first occurrence of any component of the composite of all-cause death, non fatal stroke, and need for mechanical support for severe left ventricular dysfunction (SLVD). During CABG surgery and following CABG surgery through post-operative day (POD) 28 No
Secondary To evaluate the clinical benefit of acadesine with respect to incidence of the first occurrence of any component of the composite of cardiovascular death, non fatal stroke, and need for mechanical support for SLVD During CABG surgery and following CABG surgery through POD 28 No
Primary Incidence of All-cause Death, Non-fatal Stroke, and Need for Mechanical Support for Severe Left Ventricular Dysfunction (SLVD) (Intent-to-Treat Population) Up to Post-Operative Day 28 No
Secondary Incidence of Cardiovascular Death, Non-fatal Stroke, and Need for Mechanical Support for SLVD (Intent-to-Treat Population) Up to Post-Operative Day 28 No

Sponsors