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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 the integrated management of hypertension, dyslipidemia, and type 2 diabetes among adults aged 50 to 75 years without prior cardiovascular disease in China. The trial will evaluate whether a fixed-dose combination strategy improves the 10-year cardiovascular disease risk estimated using the PREVENT equations at Phase 1. Participants will be further followed to determine whether the fixed-dose combination strategy reduces major cardiovascular events and improves cognitive outcomes 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
2026-07-11
Completion Date
2030-03-01
Last Updated
2026-09-16
Healthy Volunteers
No
Conditions
Interventions
Fixed-Dose Combination Strategy
Participants assigned to the intervention group will receive a fixed-dose combination strategy for the integrated control of blood pressure, lipid, and glucose. Eight prespecified fixed-dose formulations will be used, differing in antihypertensive intensity and rosuvastatin dose. All formulations will include olmesartan medoxomil/amlodipine, rosuvastatin, ezetimibe 10 mg, and dapagliflozin 10 mg, with indapamide 2.5 mg included in selected formulations. The olmesartan medoxomil/amlodipine dose will range from 5/1.25 mg to 20/5 mg, and the rosuvastatin dose will be either 5 mg or 10 mg. Treatment will be selected and adjusted among the prespecified fixed-dose formulations according to participants' blood pressure levels, treatment targets, tolerability, and safety. If the prespecified blood pressure, lipid, or glycemic targets are not achieved despite the highest fixed-dose regimen, additional open-label medications may be prescribed according to guideline recommendations.
Locations (15)
The First Affiliated Hospital of Henan University of Chinese Medicine
Zhengzhou, Henan, China
Affiliated Hospital of Chifeng University
Chifeng, Inner Mongolia, China
Tongliao People's Hospital
Tongliao, 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
Tieling Central Hospital
Tieling, 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