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

Evaluation of a POlypill and Colchicine for Risk Reduction in Patients With Established Atherosclerotic Cardiovascular Disease: The EPOCA Randomized Clinical Trial

Phase 3 Interventional Hospital do Coracao · NCT06930885

This study will test whether giving a daily polypill (valsartan, atorvastatin, aspirin) with or without low-dose colchicine can reduce heart attacks, strokes, or other artery-related problems in adults 45 and older who already have atherosclerotic cardiovascular disease.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment7713 (estimated)
Ages45 Years and up
SexAll
SponsorHospital do Coracao Academic / other
Locations13 sites (Maceió, Alabama and 12 other locations)
Trial IDNCT06930885 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 45 years or older with documented atherosclerotic cardiovascular disease (prior atherothrombotic event, prior arterial revascularization, or ≥50% arterial stenosis) are the intended participants.

Not a fit: People who are pregnant or breastfeeding, women of childbearing potential not using contraception, and those with severe kidney or liver disease are excluded and unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the polypill plus colchicine approach could lower the rates of heart attacks, strokes, and other atherosclerotic events while simplifying long-term medication use.

How similar studies have performed: Previous trials of polypill strategies and of low-dose colchicine (for example COLCOT and LoDoCo2) have shown reductions in inflammatory markers and some cardiovascular outcomes, but combining both approaches in a large, broad ASCVD population is less well tested.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Maceió, Alabama and 12 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Atherothrombotic DiseasesAtherosclerotic Cardiovascular DiseaseAtherothrombotic diseasesAtherosclerotic cardiovascular diseasePolypillColchicine
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.