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.
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.
Mehta
Rajendra H
RH
Duke Clinical Research Institute, Durham, NC 27715, USA.
Alexander
John H
JH
Emery
Robert
R
Ellis
Stephen J
SJ
Hasselblad
Vic
V
Khalil
Ahmad
A
Carrier
Michel
M
Harrington
Robert A
RA
Tardif
Jean-Claude
JC
D002318:Cardiovascular Diseases / Q000401:mortality / Q000517:prevention & control*; D001026:Coronary Artery Bypass; D003327:Coronary Disease / Q000188:drug therapy / Q000601:surgery*; D004311:Double-Blind Method; D006801:Humans; D009203:Myocardial Infarction / Q000453:epidemiology / Q000517:prevention & control; D011183:Postoperative Complications / Q000517:prevention & control*; D011732:Pyridoxal Phosphate / Q000009:adverse effects / Q000627:therapeutic use*; D012107:Research Design
D011732:Pyridoxal Phosphate