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NCT07679828Recruiting

Polypills Approach for Multiple Cardiovascular Risk Factors

Polypills Approach for Multiple Cardiovascular Risk Factors (PACIF) : a Multicentre, Open-label, Randomized Controlled Trial

Source: ClinicalTrials.gov · Last updated 16 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
8252 (estimated)
First submitted
21 Jun 2026
Start date
11 Jul 2026
Primary completion date
31 Dec 2029
Lead sponsor
China Medical University, China
NCT number
NCT07679828

What you commit to

  • Study type: Interventional
  • Planned participants: 8252
  • From 11 Jul 2026 to the primary completion date, 31 Dec 2029
  • 15 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Clinical diagnosis of dementia or treatment with medications for dementia

Other illness

  • Known secondary cause of hypertension
  • Type 1 diabetes
  • Pancreatic insufficiency or diabetes secondary to pancreatitis
  • History of myocardial infarction, stroke, or heart failure
  • History of coronary, cerebrovascular, or peripheral arterial revascularization
  • History of malignancy

Lab values

  • Triglycerides ≥5.65 mmol/L (500 mg/dL)
  • Abnormal serum potassium, defined as serum potassium \>5.5 mmol/L or \<3.5 mmol/L

Age

  • Life expectancy \<3 years

Other

  • 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
  • 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
  • Currently participating in another intervention study
  • Any factors judged by the clinic team to be likely to limit adherence to interventions

Who the study is looking for

  • 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

Age in the registry: 50 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (15)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Affiliated Hospital of Chifeng University
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ChifengChinaRecruiting
Shandong Provincial Hospital Affiliated to Shandong First Medical University
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JinanChinaNot yet recruiting
Central Hospital of Jinzhou
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JinzhouChinaRecruiting
Kunshan Hospital of Chinese Medicine
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KunshanChinaNot yet recruiting
Panjin Central Hospital
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PanjinChinaNot yet recruiting
First Hospital of China Medical University
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ShenyangChinaRecruiting
Shengjing Hospital Of China Medical University
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ShenyangChinaNot yet recruiting
Suzhou Wujiang District Hospital of Traditional Chinese Medicine
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SuzhouChinaNot yet recruiting
The Second Affiliated Hospital of Soochow University
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SuzhouChinaNot yet recruiting
The Fifth People's Hospital of Wujiang District
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SuzhouChinaNot yet recruiting
Taixing Second People's Hospital
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TaizhouChinaNot yet recruiting
Tieling Central Hospital
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TielingChinaRecruiting
Tiemei General Hospital of Liaoning Health Industry Group
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TielingChinaRecruiting
Tongliao People's Hospital
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TongliaoChinaNot yet recruiting
The First Affiliated Hospital of Henan University of Chinese Medicine
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ZhengzhouChinaNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.