[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100645080":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":18,"locations":27,"responsibleParty":122,"collaborators":18,"id":126,"slug":127,"hasResults":128,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":132,"eligibilityCriteria":133,"healthyVolunteers":128,"sex":134,"minAge":135,"maxAge":136,"enrollmentInfo":137,"targetDuration":18,"studyType":140,"phases":141,"briefSummary":143,"conditions":144,"keywords":148,"overallStatus":154,"whyStopped":18,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":159,"completionDateStruct":160,"leadSponsor":162,"locationsCount":163},{"fullName":5,"class":6},"China Medical University, China","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental","EXPERIMENTAL","Polypill intervention",[13],"Drug: Fixed-Dose Combination Strategy",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group","NO_INTERVENTION","Usual care",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Fixed-Dose Combination Strategy","Participants assigned to the intervention group will receive a fixed-dose combination strategy for integrated control of blood pressure, lipid, and glucose. Six predefined medication regimens will be used, differing in antihypertensive intensity and rosuvastatin dose. The antihypertensive component will consist of olmesartan medoxomil\u002Famlodipine at 10\u002F2.5 mg or 20\u002F5 mg, with indapamide 2.5 mg added if needed, and will be titrated toward a blood pressure target of \\\u003C130\u002F80 mm Hg according to prespecified protocol rules. The lipid-lowering component will be initiated with rosuvastatin 10 mg plus ezetimibe 10 mg. If suspected statin-associated adverse effects or statin intolerance occur, the rosuvastatin dose may be reduced from 10 mg to 5 mg according to prespecified protocol rules. The glucose-lowering component will consist of dapagliflozin at a fixed dose of 10 mg. Treatment will be selected and adjusted according to treatment targets, tolerability, and safety.",[9],[26],"Polypill Strategy",[28,40,49,57,62,67,75,84,92,100,105,113],{"facility":29,"status":18,"city":30,"state":31,"zip":18,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":18},"Affiliated Hospital of Chifeng University","Chifeng","Inner Mongolia","China","CN",{"type":35,"coordinates":36},"Point",[37,38],118.96361,42.26833,{"lat":38,"lon":37},{"facility":41,"status":18,"city":42,"state":43,"zip":18,"country":32,"countryCode":33,"cosmosGeoPoint":44,"geoPoint":48,"contacts":18},"Kunshan Hospital of Chinese Medicine","Kunshan","Jiangsu",{"type":35,"coordinates":45},[46,47],120.95431,31.37762,{"lat":47,"lon":46},{"facility":50,"status":18,"city":51,"state":43,"zip":18,"country":32,"countryCode":33,"cosmosGeoPoint":52,"geoPoint":56,"contacts":18},"Suzhou Wujiang District Hospital of Traditional Chinese Medicine","Suzhou",{"type":35,"coordinates":53},[54,55],120.59538,31.30408,{"lat":55,"lon":54},{"facility":58,"status":18,"city":51,"state":43,"zip":18,"country":32,"countryCode":33,"cosmosGeoPoint":59,"geoPoint":61,"contacts":18},"The Fifth People's Hospital of Wujiang District",{"type":35,"coordinates":60},[54,55],{"lat":55,"lon":54},{"facility":63,"status":18,"city":51,"state":43,"zip":18,"country":32,"countryCode":33,"cosmosGeoPoint":64,"geoPoint":66,"contacts":18},"The Second Affiliated Hospital of Soochow University",{"type":35,"coordinates":65},[54,55],{"lat":55,"lon":54},{"facility":68,"status":18,"city":69,"state":43,"zip":18,"country":32,"countryCode":33,"cosmosGeoPoint":70,"geoPoint":74,"contacts":18},"Taixing Second People's Hospital","Taizhou",{"type":35,"coordinates":71},[72,73],119.90812,32.49069,{"lat":73,"lon":72},{"facility":76,"status":18,"city":77,"state":78,"zip":18,"country":32,"countryCode":33,"cosmosGeoPoint":79,"geoPoint":83,"contacts":18},"Central Hospital of Jinzhou","Jinzhou","Liaoning",{"type":35,"coordinates":80},[81,82],121.14167,41.10778,{"lat":82,"lon":81},{"facility":85,"status":18,"city":86,"state":78,"zip":18,"country":32,"countryCode":33,"cosmosGeoPoint":87,"geoPoint":91,"contacts":18},"Panjin Central Hospital","Panjin",{"type":35,"coordinates":88},[89,90],122.0739,41.121,{"lat":90,"lon":89},{"facility":93,"status":18,"city":94,"state":78,"zip":18,"country":32,"countryCode":33,"cosmosGeoPoint":95,"geoPoint":99,"contacts":18},"First Hospital of China Medical University","Shenyang",{"type":35,"coordinates":96},[97,98],123.43278,41.79222,{"lat":98,"lon":97},{"facility":101,"status":18,"city":94,"state":78,"zip":18,"country":32,"countryCode":33,"cosmosGeoPoint":102,"geoPoint":104,"contacts":18},"Shengjing Hospital of China Medical University",{"type":35,"coordinates":103},[97,98],{"lat":98,"lon":97},{"facility":106,"status":18,"city":107,"state":78,"zip":18,"country":32,"countryCode":33,"cosmosGeoPoint":108,"geoPoint":112,"contacts":18},"Tiemei General Hospital of Liaoning Health Industry Group","Tieling",{"type":35,"coordinates":109},[110,111],123.84139,42.29306,{"lat":111,"lon":110},{"facility":114,"status":18,"city":115,"state":116,"zip":18,"country":32,"countryCode":33,"cosmosGeoPoint":117,"geoPoint":121,"contacts":18},"Shandong Provincial Hospital Affiliated to Shandong First Medical University","Jinan","Shandong",{"type":35,"coordinates":118},[119,120],116.99722,36.66833,{"lat":120,"lon":119},{"type":123,"investigatorFullName":124,"investigatorTitle":125,"investigatorAffiliation":93,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Guozhe Sun","Deputy Chief of the Department of Cardiology, First Hospital of China Medical University","100645080","polypills-approach-for-multiple-cardiovascular-risk-factors-100645080",false,"NCT07679828","Polypills Approach for Multiple Cardiovascular Risk Factors","Polypills Approach for Multiple Cardiovascular Risk Factors (PACIF) : a Multicentre, Open-label, Randomized Controlled Trial","PACIF","Inclusion Criteria:\n\n* Men or women\n* Age ≥50 years and \\\u003C75 years\n* Hypertension, defined as systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg among participants not currently taking antihypertensive medication, or systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥80 mmHg among participants currently taking any antihypertensive medication\n* Dyslipidemia, defined as LDL-C ≥1.8 mmol\u002FL (70 mg\u002FdL)\n* Type 2 diabetes with HbA1c ≥6.5% and \\\u003C12%\n* Willing to participate and able to sign informed consent\n\nExclusion Criteria:\n\n* Known secondary cause of hypertension\n* Type 1 diabetes\n* Pancreatic insufficiency or diabetes secondary to pancreatitis\n* Triglycerides ≥5.65 mmol\u002FL (500 mg\u002FdL)\n* History of coronary, carotid, or cerebrovascular revascularization within the previous 12 months\n* History of myocardial infarction or stroke within the previous 6 months\n* NYHA class III-IV heart failure at entry or hospitalization for exacerbation of chronic heart failure within the previous 6 months\n* Abnormal kidney function, defined as estimated glomerular filtration rate \\\u003C30 mL\u002Fmin\u002F1.73 m² or dialysis\n* Abnormal liver function, defined as alanine aminotransferase or aspartate aminotransferase \\>3 times the upper limit of normal\n* Abnormal serum potassium, defined as serum potassium \\>5.5 mmol\u002FL or \\\u003C3.5 mmol\u002FL\n* Contraindication to any of the components of the polypill\n* Currently living with another PACIF participant\n* Pregnancy, currently trying to become pregnant, or of child-bearing potential and not using birth control\n* Clinical diagnosis of dementia or treatment with medications for dementia\n* History of malignancy\n* Life expectancy \\\u003C3 years\n* Currently participating in another intervention study\n* Any factors judged by the clinic team to be likely to limit adherence to interventions","ALL","50 Years","75 Years",{"count":138,"type":139},8252,"ESTIMATED","INTERVENTIONAL",[142],"NA","The Polypill Approach for Multiple Cardiovascular Risk Factors (PACIF) trial is a multicenter randomized controlled trial that will test the effectiveness and safety of a fixed-dose combination strategy for integrated management of hypertension, dyslipidemia, and diabetes among adults aged 50 to 75 years in China. The trial will evaluate whether a simplified regimen combining blood pressure-lowering, lipid-lowering, and glucose-lowering therapy improves the 10-year cardiovascular disease risk score at phase 1. Participants will be followed to determine whether the fixed-dose combination strategy reduces major cardiovascular events and cognitive function compared with usual care at phase 2.",[145,146,147],"Hypertension","Dyslipidemia","Diabetes",[145,146,147,149,150,151,152,153],"Polypill","Cardiovascular disease risk","Cardiovascular Diseases","Cognitive function","Randomized controlled trial","NOT_YET_RECRUITING","2026-06-25",{"date":157,"type":158},"2026-07-01","ACTUAL",{"date":157,"type":139},{"date":161,"type":139},"2030-03-01",{"name":5,"class":6},12]