Medicure to Continue MEND-CABG II Trial as Planned

An independent data safety monitoring board has recommended that Medicure continue its Phase III MEND-CABG II trial in coronary artery bypass graft surgery patients as planned.

Medicure added that it anticipates completing study enrollment in late September, approximately two months ahead of schedule.

The Phase III MEND-CABG II trial is a double-blind, randomized, placebo-controlled clinical trial that will enroll a maximum of 3,000 patients at approximately 130 cardiac surgical centers throughout North America and Europe. Study patients will be randomized to receive placebo or MC-1 250 mg prior to surgery and for 30 days postoperatively, the company said.

The primary efficacy endpoint of MEND-CABG II is the incidence of cardiovascular death or nonfatal myocardial infarction. Study patients will be followed for 90 days postoperatively for additional safety and efficacy analysis.