CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 80 enrolled
Drug / intervention
Colchicine 0.5 MG +1 moredrug
Likely dose
Colchicine 0.5 MGfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05956145
NCT05956145N/ACompleted
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Effect of Low Dose of Colchicine on Platelet Reactivty in Patients With Chronic Coronary Disease

University of Sao Paulo·interventional·Posted Jul 21, 2023·Updated Jan 17, 2025

In Brief

A clinical study evaluating Colchicine 0.5 MG and Placebo for Platelet Aggregation, Spontaneous and Coronary Artery Disease. Completed, enrolled 80 participants across 1 site.

Detailed Summary

Inflammation plays an important role in atherosclerosis and the occurrence of ischemic events. Statins, in addition to their lipid-lowering effect, have also documented anti-inflammatory effect that may partly explain their clinical benefit in reducing cardiovascular ischemic events. Colchicine is an orally administered anti-inflammatory drug that has been used for centuries in several anti-inflammatory or autoimmune diseases. Its mechanism of action occurs by the inhibition of tubulin polymerization and the generation of microtubules and by effects on cell adhesion molecules and inflammatory chemokines. However, there are no studies evaluating the in vivo "antiplatelet action" of colchicine in patients with established cardiovascular disease. We will evaluate the effect of low-dose 0.5 mg QD colchicine for 30 ± 3 days on platelet reactivity by MultiplateTRAP. Patients with proven chronic coronary artery disease, that is, documented previous myocardial infarction, will be randomized to receive colchicine 0.5 mg QD or placebo for a period of 30 ± 3 days.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPlatelet Aggregation, Spontaneous, Coronary Artery Disease
CountriesBrazil
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedJul 21, 2023
Enrollment StartJun 17, 2021
Primary CompletionApr 3, 2024
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 2.9 years ago

Interventions

Colchicine 0.5 MGdrug

Patients with proven chronic coronary disease (documented by a previous history of AMI with or without ST-segment elevation) will be randomized to receive colchicine 0.5 mg once daily (intervention group) or placebo (control group) for a period of 30 ± 3 days.

Placeboother

Patients with proven chronic coronary disease (documented by a previous history of AMI with or without ST-segment elevation) will be randomized to receive colchicine 0.5 mg once daily (intervention group) or placebo (control group) for a period of 30 ± 3 days.