Polypills Approach for Multiple Cardiovascular Risk Factors
Polypills Approach for Multiple Cardiovascular Risk Factors (PACIF) : a Multicentre, Open-label, Randomized Controlled Trial
China Medical University, China
8,252 participants
Jul 11, 2026
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- 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 Criteria17
- 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
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Interventions
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)
View Full Details on ClinicalTrials.gov
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NCT07679828