NCT05956145Completed
Effect of Low Dose of Colchicine on Platelet Reactivity
Effect of Low Dose of Colchicine on Platelet Reactivty in Patients With Chronic Coronary Disease
Source: ClinicalTrials.gov · Last updated 17 Jan 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 80 (actual)
- First submitted
- 9 Feb 2022
- Start date
- 17 Jun 2021
- Primary completion date
- 3 Apr 2024
- Lead sponsor
- University of Sao Paulo
- Diseases
- Coronary artery disease
- NCT number
- NCT05956145
What you commit to
- Study type: Interventional
- Participants enrolled: 80
- From 17 Jun 2021 to the primary completion date, 3 Apr 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of any antithrombotic therapy other than AAS for less than 1 week;
- Abuse of drugs or alcohol;
- Current treatment with systemic corticosteroids or immunosuppressants.
Other illness
- Stroke in the last 3 months;
- Active infection or current use of systemic antimicrobial therapy;
- Inflammatory bowel disease or chronic diarrhea;
- 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
- 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;
Lab values
- 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);
Other
- Neoplasia in the last 3 years;
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Heart Institute (InCor) / University of São Paulo Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.