A randomized, double-blind, placebo-controlled, multicenter study to evaluate the cardioprotective effects of MC-1 in patients undergoing high-risk coronary artery bypass graft surgery: MC-1 to Eliminate Necrosis and Damage in Coronary Artery Bypass Graft Surgery Trial (MEND-CABG) II--study design and rationale.

Journal Article (Clinical Trial, Phase III;Journal Article;Multicenter Study)

BACKGROUND: Coronary artery bypass graft (CABG) surgery is effective in relieving angina and improving survival and quality of life in patients with obstructive coronary artery disease; however, recurrent angina, myocardial infarction, neurological injury, and death can occur in the perioperative and postoperative period. MC-1 (pyridoxal 5'-phosphate) is a novel agent that has shown promise in reducing myocardial necrosis by reducing cellular calcium overload after percutaneous coronary intervention and CABG surgery in high-risk patients undergoing these procedures. METHODS: MEND-CABG II is a phase III study evaluating the efficacy and safety of MC-1 in reducing cardiovascular morbidity and mortality after CABG. High-risk patients undergoing CABG surgery will be randomly assigned to receive either MC-1 (250 mg/d) or matching placebo immediately before and continuing for 30 days after the procedure. The primary end point is the occurrence of cardiovascular death or nonfatal myocardial infarction through postoperative day 30. A total of 3023 patients were enrolled at 130 sites in Canada, the United States, and Germany between October 2006 and September 2007, with results anticipated shortly after completion of 90-day follow-up in March 2008. CONCLUSIONS: The data from the MEND-CABG II trial will establish whether peri- and postoperative treatment with MC-1 can decrease the short- and intermediate-term morbidity and mortality of high-risk patients undergoing CABG surgery.

Full Text

Duke Authors

Cited Authors

  • Mehta, RH; Alexander, JH; Emery, R; Ellis, SJ; Hasselblad, V; Khalil, A; Carrier, M; Harrington, RA; Tardif, J-C; MEND-CABG II Investigators,

Published Date

  • April 2008

Published In

Volume / Issue

  • 155 / 4

Start / End Page

  • 600 - 608

PubMed ID

  • 18371465

Pubmed Central ID

  • 18371465

Electronic International Standard Serial Number (EISSN)

  • 1097-6744

Digital Object Identifier (DOI)

  • 10.1016/j.ahj.2008.01.002


  • eng

Conference Location

  • United States