Polypill plus colchicine to lower artery-related risk in people with atherosclerosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The EPOCA trial is a randomized, superiority, parallel 2x2 factorial Phase 3 trial across multiple centers in Brazil enrolling roughly 7,700 to 10,800 adults with established atherosclerotic cardiovascular disease. Participants are randomized to a fixed-dose cardiovascular polypill versus usual care and, independently, to colchicine 0.5 mg daily versus placebo, allowing assessment of each strategy alone and in combination. The primary comparisons will examine rates of major cardiovascular events over follow-up to see if the interventions lower risk compared with control. The design emphasizes pragmatic medication combinations to simplify therapy and target both traditional risk factors and inflammation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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's running

• Centro de Pesquisas Clínicas Dr. Marco Mota
  Maceió, Alabama, Brazil Recruiting
• Secretária da Saúde do Estado do Ceará - Hospital de Messejana Dr. Carlos Alberto Studart Gomes
  Messejana, Ceará, Brazil Recruiting
• Empresa Brasileira de Serviços Hospitalares - EBSERCH - Hospital de Ensino Dr. Washington Antônio de Barros- HU-UNIVASF
  Petrolina, Pernambuco, Brazil Recruiting
• Centro de Pesquisa Cardiolima
  Teresina, Piauí, Brazil Recruiting
• Fundação Técnico Educacional Souza Marques
  Rio de Janeiro, Rio de Janeiro, Brazil Recruiting
• Fundação Universitária de Cardiologia - ICFUC
  Porto Alegre, Rio Grande do Sul, Brazil Recruiting

Study contacts

• Principal investigator: Lucas tramujas, M.D — Hcor Research Institute

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.