[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100587630":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":48,"centralContacts":35,"locations":58,"responsibleParty":241,"collaborators":35,"id":243,"slug":35,"hasResults":244,"nctId":245,"briefTitle":246,"officialTitle":247,"acronym":248,"eligibilityCriteria":249,"healthyVolunteers":244,"sex":250,"minAge":251,"maxAge":35,"enrollmentInfo":252,"targetDuration":35,"studyType":255,"phases":256,"briefSummary":258,"conditions":259,"keywords":262,"overallStatus":61,"whyStopped":35,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":276},{"fullName":5,"class":6},"Hospital do Coracao","OTHER",[8,15,20,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1","EXPERIMENTAL","Cardiovascular Polypill + Colchicine 0.5 mg once daily",[13,14],"Drug: Cardiovascular Polypill (Valsartan, Atorvastatin, Aspirin)","Drug: Colchicine 0.5 mg",{"label":16,"type":10,"description":17,"interventionNames":18},"Group 2","Cardiovascular Polypill + Colchicine placebo 0.5 mg once daily",[13,19],"Drug: Colchicine-placebo 0.5 mg",{"label":21,"type":10,"description":22,"interventionNames":23},"Group 3","Usual care + Colchicine 0.5 mg once daily",[14,24],"Drug: Usual Care Group",{"label":26,"type":10,"description":27,"interventionNames":28},"Group 4","Usual care + Colchicine placebo 0.5 mg once daily",[24,19],[30,36,40,44],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"DRUG","Cardiovascular Polypill (Valsartan, Atorvastatin, Aspirin)","Cardiovascular Polypill contains Valsartan, Atorvastatin, Aspirin\n\n1. Valsartan 160 mg + Atorvastatin 40 mg + Aspirin 100 mg\n\n   or\n2. Valsartan 160 mg + Atorvastatin 80 mg + Aspirin 100 mg\n\n   or\n3. Valsartan 320 mg + Atorvastatin 40 mg + Aspirin 100 mg\n\n   or\n4. Valsartan 320 mg + Atorvastatin 80 mg + Aspirin100 mg\n\n   or\n5. Valsartan 80 mg + Atorvastatin 40 mg + Aspirin 100 mg\n\n   or\n6. Valsartan 80 mg + Atorvastatin 80 mg + Aspirin 100 mg\n\n   or\n7. Valsartan 80 mg + Atorvastatin 20 mg + Aspirin 100 mg\\*\n\n   or\n8. Valsartan 160 mg + Atorvastatin 20 mg + Aspirin 100 mg\\*\n\n   or\n9. Valsartan 320 mg + Atorvastatin 20 mg + Aspirin 100 mg\\*\n\n   * The use of these formulations of the cardiovascular polypill will be restricted to cases of Statin-Related Muscle Symptoms (SRMS)",[9,16],null,{"type":31,"name":37,"description":38,"armGroupLabels":39,"otherNames":35},"Colchicine 0.5 mg","Colchicine 0.5 mg once daily",[9,21],{"type":31,"name":41,"description":42,"armGroupLabels":43,"otherNames":35},"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.",[21,26],{"type":31,"name":45,"description":46,"armGroupLabels":47,"otherNames":35},"Colchicine-placebo 0.5 mg","Matching Colchicine-placebo 0.5 mg once daily",[16,26],[49,53,56],{"name":50,"affiliation":51,"role":52},"Pedro Gabriel Melo de Barros e Silva, P.h.D","Hcor Research Institute","STUDY_CHAIR",{"name":54,"affiliation":51,"role":55},"Lucas tramujas, M.D","PRINCIPAL_INVESTIGATOR",{"name":57,"affiliation":51,"role":55},"Erlon Oliveira de Abreu-Silva, M.D",[59,79,93,107,121,135,149,163,177,191,205,218,231],{"facility":60,"status":61,"city":62,"state":63,"zip":64,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":73},"Centro de Pesquisas Clínicas Dr. Marco Mota","RECRUITING","Maceió","Alabama","57051160","Brazil","BR",{"type":68,"coordinates":69},"Point",[70,71],-35.73528,-9.66583,{"lat":71,"lon":70},[74],{"name":75,"role":76,"phone":77,"phoneExt":35,"email":78},"Marco Mota, Principal Investigator","CONTACT","+55 82 3215-5032","centrodepesquisasclinicas@cesmac.edu.br",{"facility":80,"status":61,"city":81,"state":82,"zip":35,"country":65,"countryCode":66,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"Secretária da Saúde do Estado do Ceará - Hospital de Messejana Dr. Carlos Alberto Studart Gomes","Messejana","Ceará",{"type":68,"coordinates":84},[85,86],-38.48944,-3.83222,{"lat":86,"lon":85},[89],{"name":90,"role":76,"phone":91,"phoneExt":35,"email":92},"João David de Souza Neto, Principal Investigator","+55 85 399810 6905","unidadepesquisaclinica@gmail.com",{"facility":94,"status":61,"city":95,"state":96,"zip":35,"country":65,"countryCode":66,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"Empresa Brasileira de Serviços Hospitalares - EBSERCH - Hospital de Ensino Dr. Washington Antônio de Barros- HU-UNIVASF","Petrolina","Pernambuco",{"type":68,"coordinates":98},[99,100],-40.50083,-9.39861,{"lat":100,"lon":99},[103],{"name":104,"role":76,"phone":105,"phoneExt":35,"email":106},"Polyana Evangelista Lima, Principal Investigator","+55 87 2101 6504","ancianato@portalbethesda.org.br",{"facility":108,"status":61,"city":109,"state":110,"zip":35,"country":65,"countryCode":66,"cosmosGeoPoint":111,"geoPoint":115,"contacts":116},"Centro de Pesquisa Cardiolima","Teresina","Piauí",{"type":68,"coordinates":112},[113,114],-42.80194,-5.08917,{"lat":114,"lon":113},[117],{"name":118,"role":76,"phone":119,"phoneExt":35,"email":120},"Carlos Eduardo Batista Lima","+55 86 3085 3048","admin@cardiolima.com.br",{"facility":122,"status":61,"city":123,"state":123,"zip":124,"country":65,"countryCode":66,"cosmosGeoPoint":125,"geoPoint":129,"contacts":130},"Fundação Técnico Educacional Souza Marques","Rio de Janeiro","22.793-140",{"type":68,"coordinates":126},[127,128],-43.18223,-22.90642,{"lat":128,"lon":127},[131],{"name":132,"role":76,"phone":133,"phoneExt":35,"email":134},"Fabio Akio Nishijuka, Principal Investigator","+55 21 2128-4900","cepmsm@souzamarques.br",{"facility":136,"status":61,"city":137,"state":138,"zip":35,"country":65,"countryCode":66,"cosmosGeoPoint":139,"geoPoint":143,"contacts":144},"Fundação Universitária de Cardiologia - ICFUC","Porto Alegre","Rio Grande do Sul",{"type":68,"coordinates":140},[141,142],-51.23019,-30.03283,{"lat":142,"lon":141},[145],{"name":146,"role":76,"phone":147,"phoneExt":35,"email":148},"Maico Furlanetto, Principal Investigator","+55 51 3230 3860","pesquisaclinica@cardiologia.org.br",{"facility":150,"status":61,"city":151,"state":152,"zip":35,"country":65,"countryCode":66,"cosmosGeoPoint":153,"geoPoint":157,"contacts":158},"Instituto de Pesquisa e Ensino em Saúde - IPES","Porto Velho","Rondônia",{"type":68,"coordinates":154},[155,156],-63.90389,-8.76194,{"lat":156,"lon":155},[159],{"name":160,"role":76,"phone":161,"phoneExt":35,"email":162},"Marcus Vinicius Nunes Batista","+55 69 9378 7257","ipesrondonia@gmail.com",{"facility":164,"status":61,"city":165,"state":166,"zip":35,"country":65,"countryCode":66,"cosmosGeoPoint":167,"geoPoint":171,"contacts":172},"CMEP - Centro Multidisciplinar de Ensino especializado e Pesquisa","Joinville","Santa Catarina",{"type":68,"coordinates":168},[169,170],-48.84556,-26.30444,{"lat":170,"lon":169},[173],{"name":174,"role":76,"phone":175,"phoneExt":35,"email":176},"Conrado Roberto Hoffmann Filho","+55 47 9220 6886","pesquisa3@pesquisacmep.com.br",{"facility":178,"status":61,"city":179,"state":180,"zip":35,"country":65,"countryCode":66,"cosmosGeoPoint":181,"geoPoint":185,"contacts":186},"Hospital Universitário São Francisco na Providência de Deus","Bragança Paulista","São Paulo",{"type":68,"coordinates":182},[183,184],-46.54418,-22.9527,{"lat":184,"lon":183},[187],{"name":188,"role":76,"phone":189,"phoneExt":35,"email":190},"Murillo de Oliveira Antunes","+55 11 2490 1366","cepec.husf@alsf.org.br",{"facility":192,"status":61,"city":193,"state":180,"zip":194,"country":65,"countryCode":66,"cosmosGeoPoint":195,"geoPoint":199,"contacts":200},"Fundação Faculdade Regional de Medicina São José do Rio Preto","São José do Rio Preto","15.090-000",{"type":68,"coordinates":196},[197,198],-49.37944,-20.81972,{"lat":198,"lon":197},[201],{"name":202,"role":76,"phone":203,"phoneExt":35,"email":204},"Marcelo Arruda Nakazone, Principal Investigator","+55 17 3201-5054","coordenação.cardio@centrodepesquisacip.com.br",{"facility":206,"status":61,"city":207,"state":180,"zip":35,"country":65,"countryCode":66,"cosmosGeoPoint":208,"geoPoint":212,"contacts":213},"CIPES - Centro Internacional de Pesquisa Clínica","São José dos Campos",{"type":68,"coordinates":209},[210,211],-45.88694,-23.17944,{"lat":211,"lon":210},[214],{"name":215,"role":76,"phone":216,"phoneExt":35,"email":217},"Fabiana Marcondes, Principal Investigator","+55 12 99726 2171","contato@cipes.com.br",{"facility":219,"status":61,"city":180,"state":180,"zip":220,"country":65,"countryCode":66,"cosmosGeoPoint":221,"geoPoint":225,"contacts":226},"Hcor","04004-030",{"type":68,"coordinates":222},[223,224],-46.63611,-23.5475,{"lat":224,"lon":223},[227],{"name":228,"role":76,"phone":229,"phoneExt":35,"email":230},"Lucas Tramujas, Principal Investigator","+55 11 96910-7556","ltramujas@hcor.com.br",{"facility":232,"status":61,"city":180,"state":180,"zip":35,"country":65,"countryCode":66,"cosmosGeoPoint":233,"geoPoint":235,"contacts":236},"Centro de Pesquisa Cetrus",{"type":68,"coordinates":234},[223,224],{"lat":224,"lon":223},[237],{"name":238,"role":76,"phone":239,"phoneExt":35,"email":240},"Pablo de Oliveira Antunes","+55 11 91513 0651","pesquisa@cetrus.com.br",{"type":242,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","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":253,"type":254},7713,"ESTIMATED","INTERVENTIONAL",[257],"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.",[260,261],"Atherothrombotic Diseases","Atherosclerotic Cardiovascular Disease (ASCVD)",[263,264,265,266],"Atherothrombotic diseases","Atherosclerotic cardiovascular disease","Polypill","Colchicine","2026-01-21",{"date":269,"type":270},"2026-01-22","ACTUAL",{"date":272,"type":270},"2025-06-12",{"date":274,"type":254},"2031-05",{"name":5,"class":6},13]