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Effect of Low Dose of Colchicine on Platelet Reactivity

NCT05956145 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-01-17

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Colchicine 0.5 MG

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.

OTHER

Placebo

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.

Sponsors & Collaborators

  • University of Sao Paulo

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Brazil

Study Locations

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Entities

Diseases

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 NCT05956145 on ClinicalTrials.gov