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

Last updated: October 28, 2015
Sponsor: Merck Sharp & Dohme Corp.
Overall Status: Terminated

Phase

3

Condition

Stroke

Heart Disease

Angina

Treatment

N/A

Clinical Study ID

NCT00872001
P05633
MK-8395
RED-CABG
  • Ages > 50
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

  • 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

Exclusion Criteria:

  • Planned valve replacement, carotid artery or aortic surgery, distal coronaryendarterectomy,surgical ablation for cardiac arrhythmia, or ventricularaneurysmectomy, alone or with CABG surgery (repair for mild to moderate mitral valvedisease 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 balloonpump (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 UpperLimit of Normal (ULN).

  • Adenosine, aminophylline, nicotinic acid, pentoxifylline, theophylline, and anycardioplegia solution containing adenosine, dipyridamole or lidoflazine within 24hours 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

Study Design

Total Participants: 3080
Study Start date:
April 01, 2009
Estimated Completion Date:
October 31, 2010