Polypill and Colchicine for Risk Reduction in Atherosclerotic Cardiovascular Disease
Evaluation of a POlypill and Colchicine for Risk Reduction in Patients With Established Atherosclerotic Cardiovascular Disease: The EPOCA Randomized Clinical Trial
Hospital do Coracao
7,713 participants
Jun 12, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- 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 Criteria20
- 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.
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Interventions
Cardiovascular Polypill contains Valsartan, Atorvastatin, Aspirin 1. Valsartan 160 mg + Atorvastatin 40 mg + Aspirin 100 mg or 2. Valsartan 160 mg + Atorvastatin 80 mg + Aspirin 100 mg or 3. Valsartan 320 mg + Atorvastatin 40 mg + Aspirin 100 mg or 4. Valsartan 320 mg + Atorvastatin 80 mg + Aspirin100 mg or 5. Valsartan 80 mg + Atorvastatin 40 mg + Aspirin 100 mg or 6. Valsartan 80 mg + Atorvastatin 80 mg + Aspirin 100 mg or 7. Valsartan 80 mg + Atorvastatin 20 mg + Aspirin 100 mg\* or 8. Valsartan 160 mg + Atorvastatin 20 mg + Aspirin 100 mg\* or 9. Valsartan 320 mg + Atorvastatin 20 mg + Aspirin 100 mg\* * The use of these formulations of the cardiovascular polypill will be restricted to cases of Statin-Related Muscle Symptoms (SRMS)
Colchicine 0.5 mg once daily
Patients allocated to the usual care arm will receive standard of care therapies for secondary prevention according to the guidelines. Drugs and doses will be left at the discretion of the treating physicians.
Matching Colchicine-placebo 0.5 mg once daily
Locations(13)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06930885