Trends in colchicine use across the spectrum of coronary artery disease.
Lucas Tramujas, Alleh Nogueira, Nicole Felix...
https://pubmed.ncbi.nlm.nih.gov/40373935Actively Recruiting
Phase 3
Age: 45Years +
All Genders
ID06930885
Evaluation of a POlypill and Colchicine for Risk Reduction in Patients With Established Atherosclerotic Cardiovascular Disease: The EPOCA Randomized Clinical Trial
Led by Hospital do Coracao · Updated on 2026-01-22
7713
Participants Needed
13
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the effects of a polypill combined with colchicine in people with established atherosclerotic cardiovascular disease (ASCVD), a major cause of illness and death worldwide, including Brazil. The trial aims to assess whether this combination can better prevent heart and blood vessel events compared to usual care. The study addresses the need for improved control of cardiovascular risk factors and adherence to treatments in a diverse population. Participants will be randomly assigned to one of four groups: cardiovascular polypill plus colchicine, cardiovascular polypill plus placebo, usual care plus colchicine, or usual care plus placebo. The polypill contains fixed doses of valsartan, atorvastatin, and aspirin, taken daily. Colchicine or its placebo is given once daily. The study will last about three years on average, with the goal of evaluating the combined effects of these treatments on cardiovascular health. During the study, participants will be monitored for major adverse cardiovascular and limb events, including heart attacks, strokes, and cardiovascular deaths. Researchers will collect data throughout the trial to assess treatment effects and safety. The study design includes a randomized, quadruple-masked approach to ensure unbiased results. Participants can expect regular evaluations over the study period, which ends around May 2031.
CONDITIONS
Brief Title
Polypill and Colchicine for Risk Reduction in Atherosclerotic Cardiovascular Disease
Who Can Participate
Age: 45Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Individuals aged 45 years or older
- Signed informed consent form
- History of atherothrombotic cardiovascular event such as acute coronary syndrome, ischemic stroke, high-risk transient ischemic stroke, acute limb ischemia, arterial occlusion, or non-traumatic limb amputation
- Previous arterial revascularization procedure (percutaneous, surgical, or hybrid)
- Diagnosis of significant atherosclerotic disease with 50% or greater artery blockage in coronary, cerebrovascular, or peripheral arteries without prior events or revascularization
You will not qualify if you...
- Pregnant or breastfeeding women
- Women of childbearing age not using contraception
- Chronic kidney disease stage 4 or higher (eGFR 30 mL/min or less)
- Severe liver disease or cirrhosis
- Inflammatory muscle diseases or elevated muscle enzymes
- Moderate or severe heart valve disease needing intervention within 12 months
- Planned arterial revascularization within 30 days
- Left ventricular ejection fraction 40% or less, except specific cases
- Heart failure with functional class III or higher
- Blood pressure below 120/80 mmHg without blood pressure medicine
- Life expectancy 12 months or less
- Recent acute arterial event within 30 days
- Substance abuse or alcoholism
- Psychiatric or neurodegenerative disorders limiting self-care
- Participation in another randomized clinical trial
- Contraindications to polypill components or colchicine
- Current or planned oral anticoagulant use, except low-dose rivaroxaban for peripheral artery disease
- High risk of bleeding
- Current colchicine use
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Treatment
Duration - Up to approximately 3 years
Participants take a daily cardiovascular polypill and/or colchicine or placebo according to their assigned group to reduce cardiovascular risk.
Regular visits scheduled throughout treatment period
Trial Site Locations
Total: 13 locations
1
Centro de Pesquisas Clínicas Dr. Marco Mota
Maceió, Alabama, Brazil, 57051160
Actively Recruiting
2
Secretária da Saúde do Estado do Ceará - Hospital de Messejana Dr. Carlos Alberto Studart Gomes
Messejana, Ceará, Brazil
Actively Recruiting
3
Empresa Brasileira de Serviços Hospitalares - EBSERCH - Hospital de Ensino Dr. Washington Antônio de Barros- HU-UNIVASF
Petrolina, Pernambuco, Brazil
Actively Recruiting
4
Centro de Pesquisa Cardiolima
Teresina, Piauí, Brazil
Actively Recruiting
5
Fundação Técnico Educacional Souza Marques
Rio de Janeiro, Rio de Janeiro, Brazil, 22.793-140
Actively Recruiting
6
Fundação Universitária de Cardiologia - ICFUC
Porto Alegre, Rio Grande do Sul, Brazil
Actively Recruiting
7
Instituto de Pesquisa e Ensino em Saúde - IPES
Porto Velho, Rondônia, Brazil
Actively Recruiting
8
CMEP - Centro Multidisciplinar de Ensino especializado e Pesquisa
Joinville, Santa Catarina, Brazil
Actively Recruiting
9
Hospital Universitário São Francisco na Providência de Deus
Bragança Paulista, São Paulo, Brazil
Actively Recruiting
10
Fundação Faculdade Regional de Medicina São José do Rio Preto
São José do Rio Preto, São Paulo, Brazil, 15.090-000
Actively Recruiting
11
CIPES - Centro Internacional de Pesquisa Clínica
São José dos Campos, São Paulo, Brazil
Actively Recruiting
12
Hcor
São Paulo, São Paulo, Brazil, 04004-030
Actively Recruiting
13
Centro de Pesquisa Cetrus
São Paulo, São Paulo, Brazil
Actively Recruiting
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
4
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Published Research Related To This Trial
Primary results of the brazilian registry of atherothrombotic disease (NEAT).
Pedro G M de Barros E Silva, Charlene Troiani do Nascimento, Rodrigo Pinto Pedrosa...
https://pubmed.ncbi.nlm.nih.gov/38378735Polypills in the Management of Cardiovascular Risk-A Perspective.
Erlon Oliveira de Abreu-Silva, Martin Siepmann, Timo Siepmann
https://pubmed.ncbi.nlm.nih.gov/39336974Association of colchicine use with cardiovascular and limb events in peripheral artery disease: Insights from a retrospective cohort study.
Lucas Tramujas, Alleh Nogueira, Nicole Felix...
https://pubmed.ncbi.nlm.nih.gov/39299823