Polypill Approach for Multiple Cardiovascular Risk Factors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The PACIF trial is a multicenter randomized study in China comparing a fixed-dose combination polypill against usual care for adults with hypertension, dyslipidemia, and type 2 diabetes who have not yet had a cardiovascular event. Participants receive one of eight prespecified fixed-dose formulations that combine medications for blood pressure, lipids, and glucose, with dose adjustments based on targets and safety. The study aims to see if this strategy improves cardiovascular risk profiles, lowers 10-year ASCVD risk estimated by PREVENT equations, and reduces major cardiovascular events and cognitive decline over time. Additional guideline-based therapies may be added if targets are not achieved with the fixed-dose approach. Enrollment targets about 8,252 participants, ages 50–74, across several Chinese centers.

Why it matters

Who can join: the full rules

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

Where it's running

• Affiliated Hospital of Chifeng University
  Chifeng, Inner Mongolia, China Recruiting
• Central Hospital of Jinzhou
  Jinzhou, Liaoning, China Recruiting
• First Hospital of China Medical University
  Shenyang, Liaoning, China Recruiting
• Tieling Central Hospital
  Tieling, Liaoning, China Recruiting
• Tiemei General Hospital of Liaoning Health Industry Group
  Tieling, Liaoning, China Recruiting
• The First Affiliated Hospital of Henan University of Chinese Medicine
  Zhengzhou, Henan, China Not yet recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.