Polypill and Colchicine for Risk Reduction in Atherosclerotic Cardiovascular Disease
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
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
Treatments tested in this trial
- Cardiovascular Polypill (Valsartan, Atorvastatin, Aspirin)
- Colchicine 0.5 mg
- Usual Care Group
- Colchicine-placebo 0.5 mg
Treatment groups
7,713 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov