Polypills Approach for Multiple Cardiovascular Risk Factors

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 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

Conditions3

Interventions1

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