[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"atherothrombotic-diseases\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:atherothrombotic-diseases":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100587630","phase-3-polypill-and-colchicine-for-risk-reduction-in-atherosclerotic-cardiovascular-disease-100587630",false,"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","EPOCA","Inclusion Criteria:\n\n* Individuals aged ≥ 45 years AND\n* Signature of the Informed Consent Form (ICF) AND at least one of the following criteria:\n* Previous atherothrombotic cardiovascular event (acute coronary syndrome, ischemic stroke, high-risk transient ischemic stroke, acute limb ischemia\u002Farterial occlusion, or non-traumatic limb amputation) AND\u002FOR\n* Previous arterial revascularization (percutaneous, surgical, and\u002For hybrid) OR\n* 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.\n\nExclusion Criteria:\n\n* Pregnant or lactating women;\n* Women of childbearing age who do not use any form of contraception;\n* Known history of chronic kidney disease, stage ≥ 4 (estimated glomerular filtration rate ≤ 30 mL\u002Fmin, if available);\n* Known history of cirrhosis or severe liver disease (e.g., transaminase levels \\> 3 times the upper limit of normal, if available);\n* Known history of inflammatory muscle disease (e.g., dermatomyositis or polymyositis) or creatine phosphokinase (CPK) levels \\> 3 times the upper limit of normal, if available);\n* Known history of moderate or severe valvular heart disease with anticipated need for valvular intervention within the next 12 months;\n* Planned arterial revascularization (inclusion is possible 30 days after completion of all planned procedures);\n* Left ventricular ejection fraction ≤40% (with the exception of patients with documented intolerance to ACE inhibitors and\u002For sacubitril\u002Fvalsartan, who remain eligible for study enrollment);\n* Heart failure with functional class ≥ III according to the New York Heart Association (NYHA), regardless of left ventricular ejection fraction;\n* Blood pressure \\\u003C 120\u002F80 mmHg in the absence of antihypertensive therapy;\n* Life expectancy ≤ 12 months;\n* Acute arterial event (acute coronary syndrome, non-cardioembolic ischemic stroke, acute limb ischemia) in the past 30 days;\n* Substance abuse\u002Falcoholism;\n* Psychiatric and\u002For neurodegenerative disorder limiting self-care capacity;\n* Concurrent participation in another randomized clinical trial;\n* Contraindication to any component of the polypill;\n* Current or planned use of oral anticoagulant therapy within the next 12 months (except rivaroxaban 2.5 mg twice daily for patients with peripheral artery disease);\n* High risk of bleeding (e.g., but not limited to: blood dyscrasias, hemophilia, previous gastrointestinal or central nervous system bleeding);\n* Contraindication to colchicine;\n* Current use of colchicine.","ALL","45 Years",{"count":20,"type":21},7713,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","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.",[27,28],"Atherothrombotic Diseases","Atherosclerotic Cardiovascular Disease (ASCVD)",[30,31,32,33],"Atherothrombotic diseases","Atherosclerotic cardiovascular disease","Polypill","Colchicine","RECRUITING","2026-01-21",{"date":37,"type":38},"2026-01-22","ACTUAL",{"date":40,"type":38},"2025-06-12",{"date":42,"type":21},"2031-05",{"name":44,"class":45},"Hospital do Coracao","OTHER",13]