Polypills Approach for Multiple Cardiovascular Risk Factors

NCT07679828 · tracked via the Priya Life Science China tracker

Sponsor

China Medical University, China

Phase

Not applicable

Started

2026-07-11

Last updated

2026-09-16

Condition(s) studied

HypertensionDyslipidemiaDiabetes

Investigational drug(s) / intervention(s)

Fixed-Dose Combination Strategy

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.

Study 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.

Eligibility

Sex

ALL

Min age

50 Years

Max age

75 Years

Healthy volunteers

Inclusion Criteria: * Men or women * Age ≥50 years and \<75 years * Systolic blood pressure ≥130 mmHg * LDL-C ≥1.8 mmol/L (70 mg/dL) * Type 2 diabetes with HbA1c ≥6.5% and \<12% * Willing to participate and able to sign informed consent Exclusion Criteria: * Known secondary cause of hypertension * Type 1 diabetes * Pancreatic insufficiency or diabetes secondary to pancreatitis * Triglycerides ≥5.65 mmol/L (500 mg/dL) * History of myocardial infarction, stroke, or heart failure * History of coronary, cerebrovascular, or peripheral arterial revascularization * Abnormal kidney function, defined as estimated glomerular filtration rate \<30 mL/min/1.73 m² or dialysis * Abnormal liver function, defined as alanine aminotransferase or aspartate aminotransferase \>3 times the upper limit of normal * Abnormal serum potassium, defined as serum potassium \>5.5 mmol/L or \<3.5 mmol/L * Contraindication to any of the components of the polypill * Currently living with another PACIF participant * Pregnancy, currently trying to become pregnant, or of child-bearing potential and not using birth control * Clinical diagnosis of dementia or treatment with medications for dementia * History of malignancy * Life expectancy \<3 years * Currently participating in another intervention study * Any factors judged by the clinic team to be likely to limit adherence to interventions

Primary outcome measure(s)

10-year CVD risk — 12 months
Changes in 10-year CVD risk estimated by the PREVENT equations
Composite cardiovascular disease outcome — 36 months
Record the occurrence of the composite cardiovascular disease outcome, including cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, heart failure requiring hospitalization or treatment, and coronary revascularization

Trial sites (15)

Facility	City	Region	Status
The First Affiliated Hospital of Henan University of Chinese Medicine	Zhengzhou	Henan	Not Yet Recruiting
Affiliated Hospital of Chifeng University	Chifeng	Inner Mongolia	Recruiting
Tongliao People's Hospital	Tongliao	Inner Mongolia	Not Yet Recruiting
Kunshan Hospital of Chinese Medicine	Kunshan	Jiangsu	Not Yet Recruiting
Suzhou Wujiang District Hospital of Traditional Chinese Medicine	Suzhou	Jiangsu	Not Yet Recruiting
The Fifth People's Hospital of Wujiang District	Suzhou	Jiangsu	Not Yet Recruiting
The Second Affiliated Hospital of Soochow University	Suzhou	Jiangsu	Not Yet Recruiting
Taixing Second People's Hospital	Taizhou	Jiangsu	Not Yet Recruiting
Central Hospital of Jinzhou	Jinzhou	Liaoning	Recruiting
Panjin Central Hospital	Panjin	Liaoning	Not Yet Recruiting
First Hospital of China Medical University	Shenyang	Liaoning	Recruiting
Shengjing Hospital of China Medical University	Shenyang	Liaoning	Not Yet Recruiting
Tieling Central Hospital	Tieling	Liaoning	Recruiting
Tiemei General Hospital of Liaoning Health Industry Group	Tieling	Liaoning	Recruiting
Shandong Provincial Hospital Affiliated to Shandong First Medical University	Jinan	Shandong	Not Yet Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07679828 on ClinicalTrials.gov ↗ ← All trials in China