Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET 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 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

Interventions

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/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