Polypills Approach for Multiple Cardiovascular Risk Factors

NCT07679828 | Recruiting DMC

• 1 other identifier: CMU-polypill
• Study Type: interventional
• Target: 8,252
• Locations: 1 country
• Sites: 15

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 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.

Conditions

Hypertension; Dyslipidemia; Diabetes

Keywords

Hypertension; Dyslipidemia; Diabetes; Polypill; Cardiovascular disease risk; Cardiovascular Diseases; Cognitive function; Randomized 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 the composite cardiovascular disease outcome, including cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, heart failure requiring hospitalization or treatment, and coronary revascularization

  36 months

Secondary Outcomes (30)

• Major secondary endpoint: All-cause dementia

  36 months

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

  12 months

• 10-year ASCVD risk

  12 months

• 10-year HF risk

  12 months

• The proportions of participants achieving the prespecified blood pressure, LDL-C, and HbA1c targets, individually and jointly

  12 months

Study Arms (2)

Experimental

EXPERIMENTAL

Polypill intervention

Drug: Fixed-Dose Combination Strategy

Control Group

NO INTERVENTION

Usual care

Interventions

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.

Also known as: Polypill Strategy

Experimental

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women
• Age ≥50 years and \<75 years
• Systolic blood pressure ≥130 mmHg
• 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 myocardial infarction, stroke, or heart failure
• History of coronary, cerebrovascular, or peripheral arterial revascularization
• 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
• Life expectancy \<3 years

Sponsors & Collaborators

• China Medical University, China: lead

Study Sites (15)

The First Affiliated Hospital of Henan University of Chinese Medicine

Zhengzhou, Henan, China

NOT YET RECRUITING

Affiliated Hospital of Chifeng University

Chifeng, Inner Mongolia, China

RECRUITING

Tongliao People's Hospital

Tongliao, Inner Mongolia, China

NOT YET RECRUITING

Kunshan Hospital of Chinese Medicine

Kunshan, Jiangsu, China

NOT YET RECRUITING

Suzhou Wujiang District Hospital of Traditional Chinese Medicine

Suzhou, Jiangsu, China

NOT YET RECRUITING

The Fifth People's Hospital of Wujiang District

Suzhou, Jiangsu, China

NOT YET RECRUITING

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

NOT YET RECRUITING

Taixing Second People's Hospital

Taizhou, Jiangsu, China

NOT YET RECRUITING

Central Hospital of Jinzhou

Jinzhou, Liaoning, China

RECRUITING

Panjin Central Hospital

Panjin, Liaoning, China

NOT YET RECRUITING

First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

RECRUITING

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

NOT YET RECRUITING

Tieling Central Hospital

Tieling, Liaoning, China

RECRUITING

Tiemei General Hospital of Liaoning Health Industry Group

Tieling, Liaoning, China

RECRUITING

Shandong Provincial Hospital Affiliated to Shandong First Medical University

Jinan, Shandong, China

NOT YET RECRUITING

MeSH Terms

Conditions

Hypertension; Dyslipidemias; Diabetes Mellitus; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Glucose Metabolism Disorders; Endocrine 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 11, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): March 1, 2030
• Last Updated: September 16, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (15)