NCT06930885 Polypill and Colchicine for Risk Reduction in Atherosclerotic Cardiovascular Disease
| NCT ID | NCT06930885 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Hospital do Coracao |
| Condition | Atherothrombotic Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 7,713 participants |
| Start Date | 2025-06-12 |
| Primary Completion | 2031-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 7,713 participants in total. It began in 2025-06-12 with a primary completion date of 2031-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 factorial, multicenter clinical trial which will include at least 7713 and up to a maximum of 10797 participants with established atherosclerotic cardiovascular disease.
Eligibility 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.
Contact & Investigator
Pedro Gabriel Melo de Barros e Silva, P.h.D
STUDY CHAIR
Hcor Research Institute
Frequently Asked Questions
Who can join the NCT06930885 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, studying Atherothrombotic Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06930885 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 7,713 participants.
Is NCT06930885 currently recruiting?
Yes, NCT06930885 is actively recruiting participants. Visit ClinicalTrials.gov or contact Hospital do Coracao to inquire about joining.
Where is the NCT06930885 trial being conducted?
This trial is being conducted at Maceió, Brazil, Messejana, Brazil, Petrolina, Brazil, Teresina, Brazil and 9 additional locations.
Who is sponsoring the NCT06930885 clinical trial?
NCT06930885 is sponsored by Hospital do Coracao. The principal investigator is Pedro Gabriel Melo de Barros e Silva, P.h.D at Hcor Research Institute. The trial plans to enroll 7,713 participants.