Colchicine Cardiovascular Outcomes Trial (COLCOT)
NCT02551094 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 4745
Last updated 2020-10-19
Summary
The study evaluates whether long-term treatment with colchicine reduces rates of cardiovascular events in patients after myocardial infarction. Patients who have suffered a documented acute myocardial infarction within the last 30 days, are treated according to the national guidelines and after having completed any planned percutaneous revascularization procedures associated with their initial infarction will receive either colchicine (0.5 mg per day) or matching placebo (1:1 allocation ratio) for an estimated 2 years period or until the target of 301 primary endpoints has been reached.
Conditions
Interventions
- DRUG
-
colchicine
0.5 mg tablet taken once a day
- DRUG
-
colchicine placebo
sugar pill manufactured to mimic colchicine 0.5 mg tablet
Sponsors & Collaborators
-
Montreal Heart Institute
lead OTHER
Principal Investigators
-
Jean-Claude Tardif, MD · Montreal Heart Institute
-
Andreas Orfanos, MD · Montreal Health Innovations Coordinating Centre
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-12-04
- Primary Completion
- 2019-07-17
- Completion
- 2019-07-17
Countries
- Canada
Study Locations
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