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RecruitingPhase 3NCT06930885

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

Sponsor

Hospital do Coracao

Enrollment

7,713 participants

Start Date

Jun 12, 2025

Study Type

INTERVENTIONAL

Conditions

Atherosclerotic Cardiovascular Disease (ASCVD)Atherothrombotic Diseases

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

Min Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Cardiovascular Polypill (Valsartan, Atorvastatin, Aspirin), a drug called Colchicine 0.5 mg, and others for people with atherosclerotic cardiovascular disease (ascvd) and atherothrombotic diseases. The study is currently recruiting participants at 13 locations. People eligible for this study include aged 45 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCardiovascular 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)

DRUGColchicine 0.5 mg

Colchicine 0.5 mg once daily

DRUGUsual 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.

DRUGColchicine-placebo 0.5 mg

Matching Colchicine-placebo 0.5 mg once daily

Locations(13)

Centro de Pesquisas Clínicas Dr. Marco Mota

Maceió, Alabama, Brazil

Secretária da Saúde do Estado do Ceará - Hospital de Messejana Dr. Carlos Alberto Studart Gomes

Messejana, Ceará, Brazil

Empresa Brasileira de Serviços Hospitalares - EBSERCH - Hospital de Ensino Dr. Washington Antônio de Barros- HU-UNIVASF

Petrolina, Pernambuco, Brazil

Centro de Pesquisa Cardiolima

Teresina, Piauí, Brazil

Fundação Técnico Educacional Souza Marques

Rio de Janeiro, Rio de Janeiro, Brazil

Fundação Universitária de Cardiologia - ICFUC

Porto Alegre, Rio Grande do Sul, Brazil

Instituto de Pesquisa e Ensino em Saúde - IPES

Porto Velho, Rondônia, Brazil

CMEP - Centro Multidisciplinar de Ensino especializado e Pesquisa

Joinville, Santa Catarina, Brazil

Hospital Universitário São Francisco na Providência de Deus

Bragança Paulista, São Paulo, Brazil

Fundação Faculdade Regional de Medicina São José do Rio Preto

São José do Rio Preto, São Paulo, Brazil

CIPES - Centro Internacional de Pesquisa Clínica

São José dos Campos, São Paulo, Brazil

Hcor

São Paulo, São Paulo, Brazil

Centro de Pesquisa Cetrus

São Paulo, São Paulo, Brazil

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NCT06930885

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