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 groupsLocations
12Affiliated Hospital of Chifeng University ChifengInner Mongolia, China
Kunshan Hospital of Chinese Medicine KunshanJiangsu, China
Suzhou Wujiang District Hospital of Traditional Chinese Medicine SuzhouJiangsu, China
The Fifth People's Hospital of Wujiang District SuzhouJiangsu, China
Sponsors and collaborators
China Medical University, China
Lead sponsor
First Hospital of China Medical University
Sponsor institution
Source ClinicalTrials.gov