Effect of Low Dose of Colchicine on Platelet Reactivity

NCT05956145 | Completed

• 1 other identifier: SDC:5007/20/036
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Platelet Aggregation, Spontaneous; Coronary Artery Disease

Keywords

Colchicine; Coronary artery disease; chronic coronary artery disease; inflammation; platelet reactivity

Outcome Measures

Primary Outcomes (1)

• Platelet aggregation to TRAP

  Platelet aggregation assessed by the Multiplate TRAP assay and measured as area under the curve - AUC

  30 days

Secondary Outcomes (2)

• Platelet aggregation to ADP

  30 days

• Platelet aggregation to arachdonic acid

  30 days

Other Outcomes (7)

• Comparison between the colchicine and placebo groups:

  30 days

• Comparison between the colchicine and placebo groups:

  30 days

• Comparison between the colchicine and placebo groups:

  30 days

Study Arms (2)

Intervention group

EXPERIMENTAL

Colchicine 0.5 mg QD

Drug: Colchicine 0.5 MG

Placebo group

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

Colchicine 0.5 MG DRUG

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.

Intervention group

Placebo OTHER

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.

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Heart Institute (InCor) / University of São Paulo

São Paulo, São Paulo, 05403-000, Brazil

Location

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MeSH Terms

Conditions

Platelet Aggregation, Spontaneous; Coronary Artery Disease; Inflammation

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Prospective, randomized, double-blind, placebo-controlled study.

Study Record Dates

• First Submitted: February 9, 2022
• First Posted: July 21, 2023
• Study Start: June 17, 2021
• Primary Completion: April 3, 2024
• Study Completion: April 3, 2024
• Last Updated: January 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)