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Polypills Approach for Multiple Cardiovascular Risk Factors
Sponsor: China Medical University, China
Summary
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.
Official title: Polypills Approach for Multiple Cardiovascular Risk Factors (PACIF) : a Multicentre, Open-label, Randomized Controlled Trial
Key Details
Gender
All
Age Range
50 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
8252
Start Date
2026-07-01
Completion Date
2030-03-01
Last Updated
2026-07-01
Healthy Volunteers
No
Conditions
Interventions
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/amlodipine at 10/2.5 mg or 20/5 mg, with indapamide 2.5 mg added if needed, and will be titrated toward a blood pressure target of \<130/80 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.
Locations (12)
Affiliated Hospital of Chifeng University
Chifeng, Inner Mongolia, China
Kunshan Hospital of Chinese Medicine
Kunshan, Jiangsu, China
Suzhou Wujiang District Hospital of Traditional Chinese Medicine
Suzhou, Jiangsu, China
The Fifth People's Hospital of Wujiang District
Suzhou, Jiangsu, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Taixing Second People's Hospital
Taizhou, Jiangsu, China
Central Hospital of Jinzhou
Jinzhou, Liaoning, China
Panjin Central Hospital
Panjin, Liaoning, China
First Hospital of China Medical University
Shenyang, Liaoning, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Tiemei General Hospital of Liaoning Health Industry Group
Tieling, Liaoning, China
Shandong Provincial Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, China