[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100451179":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":40,"centralContacts":54,"locations":62,"responsibleParty":87,"collaborators":89,"id":96,"slug":97,"hasResults":98,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":98,"sex":104,"minAge":105,"maxAge":106,"enrollmentInfo":107,"targetDuration":28,"studyType":110,"phases":111,"briefSummary":113,"conditions":114,"keywords":117,"overallStatus":65,"whyStopped":28,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":133},{"fullName":5,"class":6},"Hospital Moinhos de Vento","OTHER",[8,15,20,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Polypill + Stroke Riskometer","EXPERIMENTAL","Participants will be randomized to use the active polypill (valsartan 80 mg, amlodipine 5 mg, and rosuvastatin 10 mg) and to use the Stroke Riskometer for lifestyle modification",[13,14],"Drug: Drug Capsule (Valsartan + Amlodipine + Rosuvastatin)","Behavioral: Stroke Riskometer",{"label":16,"type":17,"description":18,"interventionNames":19},"Placebo + Stroke Riskometer","PLACEBO_COMPARATOR","Participants will be randomized to use placebo polypill and to use the Stroke Riskometer for lifestyle modification",[14],{"label":21,"type":10,"description":22,"interventionNames":23},"Polypill + No Stroke Riskometer (Usual care)","Participants will be randomized to use the active polypill (valsartan 80 mg, amlodipine 5 mg, and rosuvastatin 10 mg) and will not use the Stroke Riskometer",[13],{"label":25,"type":26,"description":27,"interventionNames":28},"Placebo + No Riskometer (Usual Care)","NO_INTERVENTION","Participants will be randomized to use placebo polypill and will not use the Stroke Riskometer",null,[30,35],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":28},"DRUG","Drug Capsule (Valsartan + Amlodipine + Rosuvastatin)","Polypill with 3 medications (Valsartan 80 mg + Amlodipine 5 mg + Rosuvastatin 10 mg)",[21,9],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":28},"BEHAVIORAL","Stroke Riskometer","Participants will be randomized to use Stroke Riskometer App for lifestyle modifications",[16,9],[41,44,48,51],{"name":42,"affiliation":5,"role":43},"Sheila CO Martins, PhD","PRINCIPAL_INVESTIGATOR",{"name":45,"affiliation":46,"role":47},"Michael Brainin, MD","Danube University Krems, Austria","STUDY_CHAIR",{"name":49,"affiliation":50,"role":47},"Valery Feigin, PhD","AUT University, Oakland, New Zealand",{"name":52,"affiliation":5,"role":53},"Thais L Secchi, MSc","STUDY_DIRECTOR",[55,59],{"name":42,"role":56,"phone":57,"phoneExt":28,"email":58},"CONTACT","5551999628467","sheila@redebrasilavc.org.br",{"name":52,"role":56,"phone":60,"phoneExt":28,"email":61},"5551998977789","thais.secchi@hmv.org.br",[63,80],{"facility":64,"status":65,"city":66,"state":67,"zip":68,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"Unidade de Saúde Santa Cecília \u002F Hospital de Clínicas de Porto Alegre","RECRUITING","Porto Alegre","Rio Grande do Sul","90620-110","Brazil","BR",{"type":72,"coordinates":73},"Point",[74,75],-51.23019,-30.03283,{"lat":75,"lon":74},[78],{"name":79,"role":56,"phone":28,"phoneExt":28,"email":28},"Luiz A Nasi, PhD",{"facility":5,"status":65,"city":66,"state":67,"zip":28,"country":69,"countryCode":70,"cosmosGeoPoint":81,"geoPoint":83,"contacts":84},{"type":72,"coordinates":82},[74,75],{"lat":75,"lon":74},[85],{"name":86,"role":56,"phone":28,"phoneExt":28,"email":28},"Sheila Martins, PhD",{"type":88,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR",[90,93],{"name":91,"class":92},"Ministry of Health, Brazil","OTHER_GOV",{"name":94,"class":95},"World Stroke Organization","UNKNOWN","100451179","phase-3-polypill-and-riscometer-to-prevent-stroke-and-cognitive-impairment-promote-100451179",false,"NCT05155137","Polypill and RiscOMeter to Prevent StrOke and CogniTive ImpairmEnt (PROMOTE)","Polypill and RiscOMeter to Prevent StrOke and CogniTive ImpairmEnt in Primary Health Care","PROMOTE","Inclusion Criteria:\n\n* adults aged 50-75 years;\n* no previous history of stroke, TIA or cardiovascular disease;\n* systolic blood pressure (SBP) 121-139 mmHg;\n* with one or more lifestyle risk factors: smoking, overweight (BMI\\> 25 kg \u002F m2), physical inactivity (WHO criteria for aerobic physical activity \\\u003C150 minutes \u002F week or at least 75 minutes of aerobic physical activity of vigorous intensity during the week or an equivalent combination of activity of moderate and vigorous intensity) or inadequate diet \u002F poor eating habits (low intake of fruits and vegetables, fish, whole grains, high intake of drinks sweetened with sodium and sugar)\n* owns or has access to a cell phone that can receive text messages.\n\nExclusion Criteria:\n\n* Diagnostic of hypercholesterolemia (\\> 190mg\u002FdL LDL cholesterol) or diabetes or take other antihypertensive drugs or open label statins;\n* Contraindication to the medication\n* Life expectancy \\\u003C 5 years\n* Participation in another clinical trial","ALL","50 Years","75 Years",{"count":108,"type":109},8518,"ESTIMATED","INTERVENTIONAL",[112],"PHASE3","This study is a phase III, prospective, placebo-controlled randomized clinical trial involving 8,518 subjects with low to moderate stroke risk, followed for 3 years in Brazil. Participants will be randomized to receive either the polypill (valsartan 80 mg, amlodipine 5 mg, and rosuvastatin 10 mg), with dose adjustment of amlodipine to 2.5 mg for patients experiencing adverse events, or a placebo, and to either use the Stroke Riskometer for lifestyle modification or receive usual care. The purpose of the study is to test whether the polypill, alone or in combination with lifestyle modification, will reduce the incidence of stroke and cognitive impairment in this population.",[115,116],"Stroke","Cognitive Decline",[118,119,120,121,122,123],"stroke","cognitive decline","prevention","polypill","stroke riskometer","primary care","2025-01-20",{"date":126,"type":127},"2025-01-23","ACTUAL",{"date":129,"type":127},"2021-12-20",{"date":131,"type":109},"2030-12-14",{"name":5,"class":6},2]