Status:
RECRUITING
Polypill and Colchicine for Risk Reduction in Atherosclerotic Cardiovascular Disease
Lead Sponsor:
Hospital do Coracao
Conditions:
Atherothrombotic Diseases
Atherosclerotic Cardiovascular Disease (ASCVD)
Eligibility:
All Genders
45+ years
Phase:
PHASE3
Brief 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 factor...
Detailed Description
Cardiovascular disease is the leading cause of morbidity and mortality worldwide and in Brazil. Additionally, cardiovascular risk factors are highly prevalent conditions which are, frequently, present...
Eligibility Criteria
Inclusion
- 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
- Pregnant or lactating women;
- Women of childbearing age who do not use any form of contraception;
- Chronic kidney disease, stage ≥ 4 (eGFR ≤ 30 ml/min);
- Cirrhosis or severe liver disease (transaminase levels greater than 3 times the upper limit of normal);
- History of inflammatory muscle disease (e.g., dermatomyositis and polymyositis) or creatine phosphokinase (CPK) levels exceeding three times the upper limit of normal);
- History of moderate to severe valvular heart disease with planned valve 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;
- 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.
Key Trial Info
Start Date :
June 12 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2031
Estimated Enrollment :
7713 Patients enrolled
Trial Details
Trial ID
NCT06930885
Start Date
June 12 2025
End Date
May 1 2031
Last Update
September 18 2025
Active Locations (6)
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1
Centro de Pesquisa Silvestre Santé
Rio Branco, Acre, Brazil, 69915-030
2
Hospital Ruy Azevedo
Goiânia, Goiás, Brazil, 74.453-200
3
Hospital Dona Helena
Joinville, Santa Catarina, Brazil
4
Hospital Universitário São Francisco na Providência de Deus
Bragança Paulista, São Paulo, Brazil, 12.916-542