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Polypills Approach for Multiple Cardiovascular Risk Factors

ConditionsHypertensionDyslipidemiaDiabetes
Trial statusRecruiting
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 the integrated management of hypertension, dyslipidemia, and type 2 diabetes among adults aged 50 to 75 years without prior cardiovascular disease in China. The trial will evaluate whether a fixed-dose combination strategy improves the 10-year cardiovascular disease risk estimated using the PREVENT equations at Phase 1. Participants will be further followed to determine whether the fixed-dose combination strategy reduces major cardiovascular events and improves cognitive outcomes 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

Systolic blood pressure ≥130 mmHg

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 the integrated control of blood pressure, lipid, and glucose. Eight prespecified fixed-dose formulations will be used, differing in antihypertensive intensity and rosuvastatin dose. All formulations will include olmesartan medoxomil/amlodipine, rosuvastatin, ezetimibe 10 mg, and dapagliflozin 10 mg, with indapamide 2.5 mg included in selected formulations. The olmesartan medoxomil/amlodipine dose will range from 5/1.25 mg to 20/5 mg, and the rosuvastatin dose will be either 5 mg or 10 mg. Treatment will be selected and adjusted among the prespecified fixed-dose formulations according to participants' blood pressure levels, treatment targets, tolerability, and safety. If the prespecified blood pressure, lipid, or glycemic targets are not achieved despite the highest fixed-dose regimen, additional open-label medications may be prescribed according to guideline recommendations.

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 the composite cardiovascular disease outcome, including cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, heart failure requiring hospitalization or treatment, and coronary revascularization

Time frame
36 months

Secondary outcomes

1

Major secondary endpoint: All-cause dementia

Record the occurrence of all-cause dementia

Time frame
36 months
2

Hierarchical composite of all-cause mortality, nonfatal cardiovascular events, and improvement in 10-year cardiovascular disease risk estimated by the PREVENT equations

Hierarchical composite of all-cause mortality, nonfatal cardiovascular events, and improvement in 10-year cardiovascular disease risk estimated by the PREVENT equations

Time frame
12 months
3

10-year ASCVD risk

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

Time frame
12 months
4

10-year HF risk

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

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
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