Health TrialsbyHealthPanel

Polypills Approach for Multiple Cardiovascular Risk Factors

ConditionsHypertensionDyslipidemiaDiabetes
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

8,252 Participants
are divided into 2 treatment groups
Group A: ExperimentalExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

10-year CVD risk

Changes in 10-year CVD risk estimated by the PREVENT equations

Time frame
12 months
2

Composite cardiovascular disease outcome

Record the occurrence of newly diagnosed composite cardiovascular disease

Time frame
36 months

Secondary outcomes

1

Major secondary endpoint: All-cause dementia

Record all-cause dementia

Time frame
36 months
2

10-year ASCVD risk

Changes in 10-year ASCVD risk estimated by the PREVENT equations

Time frame
12 months
3

10-year HF risk

Changes in 10-year HF risk estimated by the PREVENT equations

Time frame
12 months
4

The proportion of patients achieved blood pressure target

The proportion of patients achieved blood pressure target (systolic blood pressure \<130 mmHg and diastolic blood pressure \<80 mmHg)

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

China Medical University, China

Lead sponsor

First Hospital of China Medical University

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: