drugset / Trial / NCT05956145

Effect of Low Dose of Colchicine on Platelet Reactivity

NCT05956145

Completed 80 enrolled University of Sao Paulo
RandomizedParallel-groupDouble-blindBasic science

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.

Timeline

Start
2021-06-17
Primary completion
2024-04-03
Completion
2024-04-03

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Colchicine Small molecule 0.5 mg Oral