NCT06930885

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 7,713 (estimated)
• Sponsor: Hospital do Coracao · Academic / Other
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

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.

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 in association. Despite the last therapeutic advances, rates of adequate control of these conditions are still low. One proposed strategy to increase such control and decrease cardiovascular risk is the use of fixed-dose combinations of different pharmacological classes, to be taken on single daily dose - a polypill. This strategy has already been studied in other parts of the world, especially in patients with established or at risk for coronary heart disease (CHD). Furthermore, there has been a need to explore other therapeutic targets beyond traditional risk factors that could impact the process of atherosclerosis. Among the various options evaluated, colchicine has emerged as a viable alternative, given its clinical use experience, mechanism of action, and the results showing a reduction in inflammatory biomarkers as well as clinical outcomes in individuals with different manifestations of coronary artery disease. However, it is important to highlight some key points regarding the available studies evaluating both the treatment strategy based on a polypill and the use of colchicine in the context of atherosclerotic cardiovascular disease (ASCVD). The studies supporting both approaches were primarily conducted with participants with coronary artery disease from centers in Europe, the U.S., Iran, Oceania, and India, and there is a lack of robust evidence regarding these therapeutic strategies in other countries with a diverse population like Brazil, as well as in individuals with other manifestations of ASCVD (including peripheral arterial disease and cerebrovascular disease). Given high prevalence of atherosclerotic cardiovascular disease and its traditional risk factors, low control rates, high levels of poor adherence and therapeutic inertia, and the specific realities of the population and healthcare system, evaluating the efficacy of a polypill strategy (fixed-dose an antihypertensive, aspirin, and high-potency statin) with a single daily dose, along with colchicine, in preventing cardiovascular events could contribute to improving cardiovascular care.

Conditions

• Atherothrombotic Diseases
• Atherosclerotic Cardiovascular Disease (ASCVD)

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-06-12
• Primary completion: 2031-05-01
• Completion: 2031-05-01
• First posted: 2025-04-16
• Last updated: 2026-01-22

Locations

13 sites across 1 country: Brazil