Polypills Approach for Multiple Cardiovascular Risk Factors
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-75
SponsorChina Medical University, China
About this trial
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 integrated management of hypertension, dyslipidemia, and diabetes among adults aged 50 to 75 years in China. The trial will evaluate whether a simplified regimen combining blood pressure-lowering, lipid-lowering, and glucose-lowering therapy improves the 10-year cardiovascular disease risk score at phase 1. Participants will be followed to determine whether the fixed-dose combination strategy reduces major cardiovascular events and cognitive function compared with usual care at phase 2.
Eligibility criteria
Qualifiers
Men or women
Age ≥50 years and <75 years
Hypertension, defined as systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg among participants not currently taking antihypertensive medication, or systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥80 mmHg among participants currently taking any antihypertensive medication
Dyslipidemia, defined as LDL-C ≥1.8 mmol/L (70 mg/dL)
Disqualifiers
Known secondary cause of hypertension
Type 1 diabetes
Pancreatic insufficiency or diabetes secondary to pancreatitis
Triglycerides ≥5.65 mmol/L (500 mg/dL)
Trial design
Treatments tested in this trial
- Fixed-Dose Combination Strategy
Treatment groups
8,252 Participants
are divided into 2 treatment groupsSponsors and collaborators
China Medical University, China
Lead sponsor
First Hospital of China Medical University
Sponsor institution
Source ClinicalTrials.gov