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Polypills Approach for Multiple Cardiovascular Risk Factors

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…

ClinicalTrials.gov IDNCT07679828

PhaseNA

Enrollment8252

SponsorChina Medical University, China

Age50 Years

SexALL

I'm interested View official listing

Conditions studied

Hypertension, Dyslipidemia, Diabetes

About this study

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.

Primary outcomes

10-year CVD risk (12 months)
Composite cardiovascular disease outcome (36 months)

Eligibility information

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

Study locations

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

Showing 10 of 15 reported sites. See the official listing for all locations.

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.