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RECRUITING
NCT07679828
NA

Polypills Approach for Multiple Cardiovascular Risk Factors

Sponsor: China Medical University, China

View on ClinicalTrials.gov

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

Interventions

DRUG

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