Cardiovascular diseases are the most expensive and deadly around the world. In Canada, heart attacks account for 23% of deaths attributable to cardiovascular diseases¹. Research is mandatory to understand the mechanisms of action and to resolve problems related to cardiovascular diseases.
Even if many mechanisms of action are similar for these diseases, each one has its own specifications and requires particular attention. That is why each clinical study has a very precise goal. The results will help the scientific community and will allow researchers to progress in their quest to identify efficient and safe treatments.
¹ Heart and Stroke Foundation
2012 Death Rate, per the World Health Organization
The COLCOT clinical trial intends to evaluate the impact of colchicine, a well-known anti-inflammatory medication used for hundreds of years for several conditions, on the recurrence of cardiovascular events in patients who recently suffered a heart attack.
COLCOT is a worldwide phase 3 clinical trial initiated by the Montreal Heart Institute and funded through Quebec government Arteria program. 4500 people, suitable to the eligibility criteria will participate. Participants will be randomly assigned either to the group receiving colchicine, or to the group receiving an identical product in appearance but that does not contain the active ingredient (placebo). This will allow evaluating whether it is preferable to use colchicine or not. In addition, neither the clinical research team, nor the participants, will know to which treatment they were assigned.
The primary objective of this study is to determine if long-term treatment with colchicine reduces the recurrence rates of cardiovascular events in patients who have recently been diagnosed with a heart attack (myocardial infarction (MI)).
Colchicine is a medication extracted from the Colchicum autumnale plant (see picture). It is a well-known medication already used by thousands of patients around the world to treat inflammatory diseases, such as gout and familial Mediterranean fever. Researchers made the hypothesis that the antioxidant and anti-inflammatory effects of colchicine may have a beneficial effect on atherosclerosis, by slowing down fatty plaque development and helping stabilize already existing plaques. Its antioxidant and anti-inflammatory effects could possibly reduce the recurrence of a second cardiovascular event in patients who have suffered a heart attack.
Colchicum autumnale plant
Main eligibility criteria of the COLCOT trial:
• Be 18 years of age, or older
• Have suffered a myocardial infarction in the past 30 days
• Not having undergone a coronary artery bypass graft (CABG) in the past 3 years
• Not suffering of an anti-inflammatory disease of the intestine (Crohn's disease or ulcerative colitis) or chronic diarrhea
• Not currently taking colchicine for another indication
General conduct of the study:
After the selection period, participants will be randomly assigned to one of the two groups of treatment, either colchicine or placebo.
During the entire conduct of the study, participants will take the study medication (colchicine or placebo) tablets, once per day. In addition, they will visit the study doctor twice per year, and will have 2 phone calls per year, in alternation.
Where does the study take place:
The study takes place in several hospitals and clinics in many countries:
- Czech Republic
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