NCT07679828

Brief Summary

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8,252

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
44mo left

Started Jul 2026

Longer than P75 for not_applicable hypertension

Geographic Reach
1 country

12 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
Jul 2026Mar 2030

First Submitted

Initial submission to the registry

June 21, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 1, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2029

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2030

Last Updated

July 1, 2026

Status Verified

June 1, 2026

Enrollment Period

3.5 years

First QC Date

June 21, 2026

Last Update Submit

June 25, 2026

Conditions

HypertensionDyslipidemiaDiabetes

Keywords

HypertensionDyslipidemiaDiabetesPolypillCardiovascular disease riskCardiovascular DiseasesCognitive functionRandomized controlled trial

Outcome Measures

Primary Outcomes (2)

  • 10-year CVD risk

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

    12 months

  • Composite cardiovascular disease outcome

    Record the occurrence of newly diagnosed composite cardiovascular disease

    36 months

Secondary Outcomes (37)

  • Major secondary endpoint: All-cause dementia

    36 months

  • 10-year ASCVD risk

    12 months

  • 10-year HF risk

    12 months

  • The proportion of patients achieved blood pressure target

    12 months

  • The proportion of patients achieved LDL-C target

    12 months

  • +32 more secondary outcomes

Study Arms (2)

Experimental

EXPERIMENTAL

Polypill intervention

Drug: Fixed-Dose Combination Strategy

Control Group

NO INTERVENTION

Usual care

Interventions

Fixed-Dose Combination StrategyDRUG

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.

Also known as: Polypill Strategy
Experimental

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • Type 2 diabetes with HbA1c ≥6.5% and \<12%
  • Willing to participate and able to sign informed consent

You may not qualify if:

  • Known secondary cause of hypertension
  • Type 1 diabetes
  • Pancreatic insufficiency or diabetes secondary to pancreatitis
  • Triglycerides ≥5.65 mmol/L (500 mg/dL)
  • History of coronary, carotid, or cerebrovascular revascularization within the previous 12 months
  • History of myocardial infarction or stroke within the previous 6 months
  • NYHA class III-IV heart failure at entry or hospitalization for exacerbation of chronic heart failure within the previous 6 months
  • Abnormal kidney function, defined as estimated glomerular filtration rate \<30 mL/min/1.73 m² or dialysis
  • Abnormal liver function, defined as alanine aminotransferase or aspartate aminotransferase \>3 times the upper limit of normal
  • Abnormal serum potassium, defined as serum potassium \>5.5 mmol/L or \<3.5 mmol/L
  • Contraindication to any of the components of the polypill
  • Currently living with another PACIF participant
  • Pregnancy, currently trying to become pregnant, or of child-bearing potential and not using birth control
  • Clinical diagnosis of dementia or treatment with medications for dementia
  • History of malignancy
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Affiliated Hospital of Chifeng University

Chifeng, Inner Mongolia, China

Location

Kunshan Hospital of Chinese Medicine

Kunshan, Jiangsu, China

Location

Suzhou Wujiang District Hospital of Traditional Chinese Medicine

Suzhou, Jiangsu, China

Location

The Fifth People's Hospital of Wujiang District

Suzhou, Jiangsu, China

Location

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Location

Taixing Second People's Hospital

Taizhou, Jiangsu, China

Location

Central Hospital of Jinzhou

Jinzhou, Liaoning, China

Location

Panjin Central Hospital

Panjin, Liaoning, China

Location

First Hospital of China Medical University

Shenyang, Liaoning, China

Location

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

Location

Tiemei General Hospital of Liaoning Health Industry Group

Tieling, Liaoning, China

Location

Shandong Provincial Hospital Affiliated to Shandong First Medical University

Jinan, Shandong, China

Location

MeSH Terms

Conditions

HypertensionDyslipidemiasDiabetes MellitusCardiovascular Diseases

Condition Hierarchy (Ancestors)

Vascular DiseasesLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism DisordersEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome Assessment Committee members will be blinded to outcome assignment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Chief of the Department of Cardiology, First Hospital of China Medical University

Study Record Dates

First Submitted

June 21, 2026

First Posted

July 1, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

March 1, 2030

Last Updated

July 1, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(12)