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

Merck Sharp & Dohme (MSD)

Status and phase: Terminated; Phase 3

Conditions: Ventricular Dysfunction, Left; Stroke; Cardiopulmonary Bypass; Coronary Artery Bypass; Myocardial Infarction

Treatments: Drug: Acadesine; Drug: Normal Saline

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00872001

P05633

RED-CABG (Other Identifier)

MK-8395 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 3,080 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• A high risk participant undergoing non emergency CABG surgery requiring CPB and cardioplegia.

• Age: >=50 years

• At least one of the following risk factors:

  • Female (but not pregnant or lactating), or
  • History of prior CABG, or
  • History of myocardial infarction (MI), or
  • History of ischemic stroke, or
  • Left ventricular ejection fraction <=30%, or
  • Diabetes mellitus requiring insulin and/or antidiabetic agents.

• Significant coronary artery stenosis

Exclusion criteria

• Planned valve replacement, carotid artery or aortic surgery, distal coronary endarterectomy,surgical ablation for cardiac arrhythmia, or ventricular aneurysmectomy, alone or with CABG surgery (repair for mild to moderate mitral valve disease with concomitant CABG is not excluded).
• Planned or staged major surgery within 30 days of CABG surgery
• CABG surgery using intermittent aortic cross clamping without cardioplegia.
• Minimally invasive surgery (ie, without use of CPB).
• MI within 5 days prior to surgery.
• Pre-operative or planned intra operative/postoperative use of intra-aortic balloon pump (IABP), ventricular assist device (VAD), extra-corporeal membrane oxygenator (ECMO), or other mechanical hemodynamic assist device.
• History or presence of gout or uric acid nephrolithiasis.
• Serum creatinine >2 mg/dL (180 µmol/L).
• Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 x Upper Limit of Normal (ULN).
• Adenosine, aminophylline, nicotinic acid, pentoxifylline, theophylline, and any cardioplegia solution containing adenosine, dipyridamole or lidoflazine within 24 hours before surgery:
• Dipyridamole within 2 days and allopurinol or febuxostat within 4 days before surgery
• Food and drinks containing caffeine, theobromines or methylxanthines (such as coffee, tea, colas, some 'energy' drinks or chocolate) within 12 hours before surgery.
• Pregnancy

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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3,080 participants in 2 patient groups, including a placebo group

Acadesine

Active Comparator group

Description:

Acadesine intravenous (IV) infusion, plus cardioplegia solution with acadesine, and priming solution with acadesine in the heart lung machine during cardiopulmonary bypass (CPB)

Treatment:

Drug: Acadesine

Placebo

Placebo Comparator group

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

Treatment:

Drug: Normal Saline