MEND-CABG II - Phase III Trial
MEND-CABG II was a double-blind, randomized, placebo-controlled clinical trial that enrolled 3,023 patients undergoing CABG surgery at approximately 130 cardiac surgical centers throughout North America and Europe. Study patients were randomized to receive placebo or MC-1 250mg prior to surgery and for 30 days post operatively (POD 30). The primary efficacy endpoint of MEND-CABG II was the reduction in the composite of cardiovascular death and non-fatal myocardial infarction up to POD 30. Study patients were followed for 60 days after treatment (90 days post operatively) for additional safety and efficacy analysis.
Medicure conducted the MEND-CABG II study in conjunction with the Duke Clinical Research Institute (DCRI) and Montreal Heart Institute (MHI). Principal investigators for the study were Dr. Robert Harrington, Director of DCRI, and Dr. Michel Carrier, Director of Cardiovascular Surgery Program at MHI.
CABG is a medical procedure performed to improve blood flow to the heart by re-routing blood around the blocked artery. Due to the high incidence of coronary artery disease worldwide, as well as the effectiveness of this surgical procedure, CABG surgery is one of the 10 most frequently performed procedures in North America.
On February 22nd, 2008 Medicure announced that MEND-CABG II did not achieve its primary effiacy endpoint
Click here to view the MEND-CABG II publication.
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