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Polypill and Colchicine for Risk Reduction in Atherosclerotic Cardiovascular Disease

NCT06930885 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 7713

Last updated 2026-01-22

No results posted yet for this study

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.

Conditions

  • Atherothrombotic Diseases
  • Atherosclerotic Cardiovascular Disease (ASCVD)

Interventions

DRUG

Cardiovascular Polypill (Valsartan, Atorvastatin, Aspirin)

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)

DRUG

Colchicine 0.5 mg

Colchicine 0.5 mg once daily

DRUG

Usual Care Group

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.

DRUG

Colchicine-placebo 0.5 mg

Matching Colchicine-placebo 0.5 mg once daily

Sponsors & Collaborators

  • Hospital do Coracao

    lead OTHER

Principal Investigators

  • Pedro Gabriel Melo de Barros e Silva, P.h.D · Hcor Research Institute

  • Lucas tramujas, M.D · Hcor Research Institute

  • Erlon Oliveira de Abreu-Silva, M.D · Hcor Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-12
Primary Completion
2031-05-31
Completion
2031-05-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06930885 on ClinicalTrials.gov