Polypill and Colchicine for Risk Reduction in Atherosclerotic Cardiovascular Disease

ConditionsAtherothrombotic Diseases Atherosclerotic Cardiovascular Disease (ASCVD)

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age45+

SponsorHospital do Coracao

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Individuals aged ≥ 45 years AND

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.

Disqualifiers

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);

Trial design

Design model

Factorial

Treatments tested in this trial

Cardiovascular Polypill (Valsartan, Atorvastatin, Aspirin)
Drug
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)
Colchicine 0.5 mg
Drug
Colchicine 0.5 mg once daily
Usual Care Group
Drug
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.
Colchicine-placebo 0.5 mg
Drug
Matching Colchicine-placebo 0.5 mg once daily

Treatment groups

7,713 Participants

are divided into 4 treatment groups

Group A: Group 1Experimental treatment 2 interventions

Group B: Group 2Experimental treatment 2 interventions

Group C: Group 3Experimental treatment 2 interventions

Group D: Group 4Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

Primary efficacy endpoint: Major adverse cardiovascular and limb events (MACLE)

Time to cardiovascular death, non-fatal type 1 myocardial infarction, non-fatal ischemic stroke, urgent arterial revascularization, and non-traumatic major lower limb amputation

Time frame