Actively Recruiting
Polypill and Colchicine for Risk Reduction in Atherosclerotic Cardiovascular Disease
Led by Hospital do Coracao · Updated on 2026-01-22
7713
Participants Needed
13
Research Sites
307 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The EPOCA study (Evaluation of a POlypill and Colchicine for risk reduction in patients with established Atherosclerotic cardiovascular disease) will be a randomized, superiority, parallel, 2x2 factorial, multicenter clinical trial which will include at least 7713 and up to a maximum of 10797 participants with established atherosclerotic cardiovascular disease.
CONDITIONS
Official Title
Polypill and Colchicine for Risk Reduction in Atherosclerotic Cardiovascular Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Individuals aged 45 years or older
- Signed informed consent form
- History of previous atherothrombotic cardiovascular event such as acute coronary syndrome, ischemic stroke, high-risk transient ischemic stroke, acute limb ischemia or arterial occlusion, or non-traumatic limb amputation
- Or previous arterial revascularization by percutaneous, surgical, or hybrid methods
- Or diagnosis of significant atherosclerotic disease with 50% or greater blockage in any artery (coronary, cerebrovascular, or peripheral) without prior cardiovascular event 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 creatine phosphokinase levels
- Moderate or severe heart valve disease expected to need intervention within 12 months
- Planned arterial revascularization (unless completed more than 30 days ago)
- Left ventricular ejection fraction 40% or less (except patients intolerant to ACE inhibitors or sacubitril/valsartan)
- Heart failure with New York Heart Association class III or higher
- Blood pressure below 120/80 mmHg without antihypertensive treatment
- Life expectancy of 12 months or less
- Acute arterial event within past 30 days
- Substance abuse or alcoholism
- Psychiatric or neurodegenerative disorders limiting self-care
- Participation in another randomized clinical trial
- Contraindication to any polypill component
- Current or planned use of oral anticoagulants within 12 months (except low-dose rivaroxaban for peripheral artery disease)
- High bleeding risk
- Contraindication to colchicine
- Current use of colchicine
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
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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