Colchicine Cardiovascular Outcomes Trial (COLCOT)

NCT02551094 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 4745

Last updated 2020-10-19

Study results available
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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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02551094 on ClinicalTrials.gov