Effect of Low Dose of Colchicine on Platelet Reactivty in Patients With Chronic Coronary Disease

SDC:5007/20/036

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.

2021-06-17

2024-04-15

2024-04-15

Recruiting

Early phase I

80

Inclusion Criteria: * Agreement to sign a free and informed consent form (ICF); * Age equal or major18 years; * Patients with previous acute myocardial infarction (for more than 1 year) according to the criteria of the 4th universal definition using ASA 100mg / day. Exclusion Criteria: * Use of any antithrombotic therapy other than AAS for less than 1 week; * Stroke in the last 3 months; * Active infection or current use of systemic antimicrobial therapy; * Neoplasia in the last 3 years; * Inflammatory bowel disease or chronic diarrhea; * Hematological abnormality (Hb equal or minor to11 g / dL or major to17g / dL, Leukocytes minor or equal 4,500 / mm3 or major 11,000 / mm3, platelet count minor 150,000 / mm3 or major450,000 / mm3); * Chronic kidney disease (estimated glomerular filtration rate \<30 ml / min / 1.73 m2) using the MDRD17 formula; * Liver disease defined by CHILD B or C; 18,19 * Abuse of drugs or alcohol; * Dementia, psychiatric or any condition that, in the opinion of the researcher, prevents participation and follow-up in the protocol; * History of allergy to colchicine; * Current treatment with systemic corticosteroids or immunosuppressants.

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2024-01-23