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document
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 .
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Intervention_Control
placebo-controlled
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Intervention_Pharmacological
MC-1
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Intervention_Pharmacological
MC-1
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Intervention_Pharmacological
MC-1
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Intervention_Pharmacological
MC-1
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Intervention_Pharmacological
MC-1
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Intervention_Control
placebo
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Intervention_Pharmacological
MC-1
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Outcome_Physical
Coronary Artery
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Outcome_Other
efficacy
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Outcome_Other
safety
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Outcome_Mortality
occurrence of cardiovascular death
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Outcome_Physical
nonfatal myocardial infarction
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Outcome_Physical
short- and intermediate-term morbidity
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Outcome_Mortality
mortality
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Participant_Condition
high-risk coronary artery bypass graft surgery
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Participant_Condition
obstructive coronary artery disease
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Participant_Condition
High-risk patients undergoing CABG surgery
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Participant_Sample-size
3023 patients