Polypill and Colchicine for Risk Reduction in Atherosclerotic Cardiovascular Disease

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Atherothrombotic Diseases, Atherosclerotic Cardiovascular Disease (ASCVD)

In brief

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.

Key facts

Study ID

NCT06930885

Run by

Hospital do Coracao

People needed

7713

Starts

2025-06-12

Expected to finish

2031-05-01

Last updated by the study team

2026-01-22

Who can join

Age: 45 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Individuals aged ≥ 45 years AND
• Signature of the Informed Consent Form (ICF) AND at least one of the following criteria:
• Previous atherothrombotic cardiovascular event (acute coronary syndrome, ischemic stroke, high-risk transient ischemic stroke, acute limb ischemia/arterial occlusion, or non-traumatic limb amputation) AND/OR
• Previous arterial revascularization (percutaneous, surgical, and/or hybrid) OR
• Diagnosis of significant atherosclerotic disease with ≥ 50% obstruction in any arterial territory (coronary, cerebrovascular, or peripheral), in the absence of a prior cardiovascular event or arterial revascularization.

You may not qualify if…

• Pregnant or lactating women;
• Women of childbearing age who do not use any form of contraception;
• Known history of chronic kidney disease, stage ≥ 4 (estimated glomerular filtration rate ≤ 30 mL/min, if available);
• Known history of cirrhosis or severe liver disease (e.g., transaminase levels > 3 times the upper limit of normal, if available);
• Known history of inflammatory muscle disease (e.g., dermatomyositis or polymyositis) or creatine phosphokinase (CPK) levels > 3 times the upper limit of normal, if available);
• Known history of moderate or severe valvular heart disease with anticipated need for valvular intervention within the next 12 months;
• Planned arterial revascularization (inclusion is possible 30 days after completion of all planned procedures);
• Left ventricular ejection fraction ≤40% (with the exception of patients with documented intolerance to ACE inhibitors and/or sacubitril/valsartan, who remain eligible for study enrollment);
• Heart failure with functional class ≥ III according to the New York Heart Association (NYHA), regardless of left ventricular ejection fraction;
• Blood pressure < 120/80 mmHg in the absence of antihypertensive therapy;
• Life expectancy ≤ 12 months;
• Acute arterial event (acute coronary syndrome, non-cardioembolic ischemic stroke, acute limb ischemia) in the past 30 days;
• Substance abuse/alcoholism;
• Psychiatric and/or neurodegenerative disorder limiting self-care capacity;
• Concurrent participation in another randomized clinical trial;
• Contraindication to any component of the polypill;
• Current or planned use of oral anticoagulant therapy within the next 12 months (except rivaroxaban 2.5 mg twice daily for patients with peripheral artery disease);
• High risk of bleeding (e.g., but not limited to: blood dyscrasias, hemophilia, previous gastrointestinal or central nervous system bleeding);
• Contraindication to colchicine;
• Current use of colchicine.

Where it is running

• Centro de Pesquisas Clínicas Dr. Marco Mota — Maceió, Alabama, Brazil (enrolling)
• Secretária da Saúde do Estado do Ceará - Hospital de Messejana Dr. Carlos Alberto Studart Gomes — Messejana, Ceará, Brazil (enrolling)
• Empresa Brasileira de Serviços Hospitalares - EBSERCH - Hospital de Ensino Dr. Washington Antônio de Barros- HU-UNIVASF — Petrolina, Pernambuco, Brazil (enrolling)
• Centro de Pesquisa Cardiolima — Teresina, Piauí, Brazil (enrolling)
• Fundação Técnico Educacional Souza Marques — Rio de Janeiro, Rio de Janeiro, Brazil (enrolling)
• Fundação Universitária de Cardiologia - ICFUC — Porto Alegre, Rio Grande do Sul, Brazil (enrolling)
• Instituto de Pesquisa e Ensino em Saúde - IPES — Porto Velho, Rondônia, Brazil (enrolling)
• CMEP - Centro Multidisciplinar de Ensino especializado e Pesquisa — Joinville, Santa Catarina, Brazil (enrolling)
• Hospital Universitário São Francisco na Providência de Deus — Bragança Paulista, São Paulo, Brazil (enrolling)
• Fundação Faculdade Regional de Medicina São José do Rio Preto — São José do Rio Preto, São Paulo, Brazil (enrolling)
• CIPES - Centro Internacional de Pesquisa Clínica — São José dos Campos, São Paulo, Brazil (enrolling)
• Hcor — São Paulo, São Paulo, Brazil (enrolling)
• Centro de Pesquisa Cetrus — São Paulo, São Paulo, Brazil (enrolling)

Full record on ClinicalTrials.gov

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