News | September 19, 2007

Medicure Completes Enrollment in CABG II Trial

September 20, 2007 - Medicure Inc. today announced the completion of enrollment of 3,000 patients in its MEND-CABG II trial, as the company plans to develop the first cardioprotective therapy approved to reduce mortality and morbidity in the CABG patient population.

The Phase 3 trial for registration is evaluating the Company’s FDA Fast Tracked product MC-1’s safety and cardioprotective efficacy in patients undergoing coronary artery bypass graft (CABG) surgery.

The Phase 3 MEND-CABG II trial is a double-blind, randomized, placebo-controlled clinical trial that enrolled 3,000 patients undergoing CABG surgery at approximately 130 cardiac surgical centers throughout North America and Europe. Study patients were randomized to receive placebo or MC-1 250 mg prior to surgery and for 30 days post operatively (POD 30). The primary efficacy endpoint of MEND-CABG II is the incidence of cardiovascular death or non-fatal myocardial infarction up to and including POD 30. Study patients will be followed for 60 days after treatment (90 days post operatively) for additional safety and efficacy analysis. The study was initiated in November 2006 and is subject to a Special Protocol Assessment with the FDA.

For more information: www.medicure.com

Related Content

Bilateral Artery Use Does Not Improve 10-Year CABG Outcomes
News | Cardiovascular Surgery | September 06, 2018
While it is firmly established that the use of one internal thoracic artery can improve life expectancy in coronary...
Mandatory Public Coronary Artery Bypass Grafting Reporting Associated With Better Patient Outcomes
News | Cardiovascular Surgery | April 30, 2018
Mandatory public reporting of coronary artery bypass grafting (CABG) results in Massachusetts was associated with...
Gecko Biomedical Receives CE Mark Approval for Setalum Sealant
News | Cardiovascular Surgery | September 19, 2017
Gecko Biomedical announced it has received CE Mark approval for its Setalum Sealant, allowing the company to market its...
ClearFlow Inc. Announces Positive U.S. Clinical Trial Results
News | Cardiovascular Surgery | September 08, 2017
September 8, 2017 — ClearFlow Inc.
Videos | Cardiovascular Surgery | July 19, 2017
This video educational session, provided in partnership with the American Society of Echocardiography (ASE), is title
Intensive Glycemic Control Program Produces Significant Per-Patient Cost Savings for CABG Surgery
News | Cardiovascular Surgery | May 25, 2017
A new study from Emory University observed a near-20 percent reduction in perioperative complications, a 1.2-day...
Risk of Heart Transplant Rejection Reduced by Desensitizing Patient Antibodies
News | Cardiovascular Surgery | May 23, 2017
The risk of heart transplant rejection can be reduced by desensitizing patient antibodies, according to research...
Scientists Show How Cells React to Injury From Open-Heart Surgery
News | Cardiovascular Surgery | May 04, 2017
Cedars-Sinai Heart Institute investigators have learned how cardiac muscle cells react to a certain type of injury that...
ERACS Session Highlights Need for Standardized Best Practices in Cardiac Surgery
News | Cardiovascular Surgery | May 02, 2017
The recently formed group Enhanced Recovery After Cardiac Surgery (ERACS) hosted an organizing session in Boston on...
ClearFlow Receives Frost & Sullivan New Product Innovation Award for PleuraFlow Technology
News | Cardiovascular Surgery | May 01, 2017
ClearFlow Inc. has received the prestigious 2017 Global Frost & Sullivan Award for New Product Innovation. The...
Overlay Init