November 20, 2019 — The Montreal Heart Institute (MHI) announced results from the COLchicine Cardiovascular Outcomes Trial (COLCOT). The clinical trial compared colchicine to placebo on top of standard of care in preventing ischemic cardiovascular events in patients who recently suffered from a heart attack (myocardial infarction). In this study, patients receiving colchicine 0.5mg daily had a significantly lower rate of ischemic cardiovascular events (first and recurrent) than those on placebo1.
These results were published today in the New England Journal of Medicine (NEJM) and simultaneously presented at the American Heart Association (AHA) Late-Breaking Scientific Session.
In summary, colchicine significantly reduces the risk of a first ischemic cardiovascular event and of total ischemic cardiovascular events by 23% and 34% respectively in addition to standard of care in patients with a recent myocardial infarction (MI).
The primary efficacy endpoint was a composite of cardiovascular death, resuscitated cardiac arrest, MI, stroke or urgent hospitalization for angina requiring coronary revascularization1. Patients were also treated according to national guidelines that included the intensive use of statins1.
The trial demonstrated that the treatment with colchicine reduced by:
• 23% the risk of a first event of the primary efficacy endpoint;
• 34% the risk of total (first and recurrent) events of the primary efficacy endpoint;
• 29% the risk of a first event of the primary efficacy endpoint in patients who adhered to the protocol.
“The data from the COLCOT trial underscore the potential of colchicine as an efficient and critically needed therapy for reducing inflammation post-myocardial infarction to improve patient cardiovascular outcomes.” said Dr. Jean-Claude Tardif, Director of the Research Center at the Montreal Heart Institute, Professor of Medicine at the University of Montreal, and COLCOT primary investigator. Dr Tardif also outlines that by repurposing older drugs, the COLCOT trial exemplifies how to bring innovation in the field of life and health sciences in a time- and cost-effective manner.
About the COLchicine Cardiovascular Outcomes Trial (COLCOT)
Colchicine is an orally administered anti-inflammatory medication that is currently indicated for the management of pericarditis, gout, familial Mediterranean fever. Initiated by a researcher from the Montreal Heart Institute, COLCOT was a randomized, double-blind, clinical trial comparing colchicine 0.5 mg once daily with placebo on top of standard of care.|
The trial took place across 167 research sites in 12 countries. The colchicine used in this trial was provided by Pharmascience Inc., Canada. The Montreal Health Innovations Coordinating Center (MHICC) managed the study and conducted the statistical analyses. Study endpoints were evaluated and confirmed by an independent committee composed of cardiologists and neurologists. The trial was overseen by an independent data safety monitoring board. Within 30 days of their MI, the 4,745 COLCOT patients were randomized to receive colchicine 0.5mg daily or placebo, on top of their standard of care. They have been subsequently followed for a median of 23 months.1
About the Montreal Heart Institute
Founded in 1954, the Montreal Heart Institute constantly aims for the highest standards of excellence in the cardiovascular field through its leadership in clinical and basic research, ultra-specialized care, professional training and prevention. It houses the largest cardiovascular research center in Canada, the largest cardiovascular prevention center in the country, and the largest cardiovascular genetics center in the country. The Institute is affiliated with the University of Montreal and has more than 2,000 employees, including 245 doctors and more than 85 researchers.
About the Montreal Health Innovations Coordinating Center (MHICC)
The Montreal Health Innovations Coordinating Center (MHICC) is a leading academic clinical research organization and an integral part of the Montreal Heart Institute (MHI). The MHICC possesses an established network of collaborators in over 4,500 clinical sites in more than 30 countries. It has specific expertise in precision medicine, high-quality, cost-effective, and drug repurposing clinical trials.
1. Tardif J-C, Kouz S, Waters D, et al. Efficacy and safety of low-dose colchicine after myocardial infarction. N Engl J Med 2019. Available at www.nejm.org