Polypills Approach for Multiple Cardiovascular Risk Factors

Sponsor
China Medical University, China
Study ID
NCT07679828
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Fixed-Dose Combination Strategy — DRUG
    Participants assigned to the intervention group will receive a fixed-dose combination strategy for integrated control of blood pressure, lipid, and glucose. Six predefined medication regimens will be used, differing in antihypertensive intensity and rosuvastatin dose. The antihypertensive component will consist of olmesartan medoxomil/amlodipine at 10/2.5 mg or 20/5 mg, with indapamide 2.5 mg added if needed, and will be titrated toward a blood pressure target of \<130/80 mm Hg according to prespecified protocol rules. The lipid-lowering component will be initiated with rosuvastatin 10 mg plus ezetimibe 10 mg. If suspected statin-associated adverse effects or statin intolerance occur, the rosuvastatin dose may be reduced from 10 mg to 5 mg according to prespecified protocol rules. The glucose-lowering component will consist of dapagliflozin at a fixed dose of 10 mg. Treatment will be selected and adjusted according to treatment targets, tolerability, and safety.

Study Details

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.

Key Dates

First listed
Jul 1, 2026
Start date
Jul 1, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2029
Completion
Mar 1, 2030

Study Design

Enrollment
8,252 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental
    Polypill intervention
  • No Intervention: Control Group
    Usual care

Primary Outcome Measure

10-year CVD risk [ Time Frame: 12 months ]

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