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Polypills Approach for Multiple Cardiovascular Risk Factors (PACIF)

12. september 2026 oppdatert av: Guozhe Sun, China Medical University, China

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

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

The overall objective of the PACIF Trial is to test a fixed-dose combination strategy for the integrated management of hypertension, dyslipidemia, and diabetes. This multicenter randomized controlled trial will evaluate whether a polypill-based approach, compared with usual care, improves cardiovascular risk factor control and reduces cardiovascular disease events among adults with multiple cardiovascular risk factors but without prior cardiovascular disease. The trial will recruit an estimated 8,252 participants aged 50 to <75 years who have hypertension, dyslipidemia, and type 2 diabetes. Participants will be randomly assigned to receive either a fixed-dose combination strategy or usual care.

In the intervention group, the study medication regimen will consist of eight prespecified fixed-dose formulations combining blood pressure-lowering, lipid-lowering, and glucose-lowering therapies. These formulations include olmesartan medoxomil/amlodipine, rosuvastatin, ezetimibe, and dapagliflozin, with indapamide included in selected formulations. Treatment will be adjusted among the prespecified fixed-dose formulations according to participants' blood pressure levels, treatment targets, tolerability, and safety. Additional open-label medications may be used according to guideline recommendations and clinical judgment if the prespecified treatment targets are not achieved with the fixed-dose combination strategy. Treatment targets are defined as blood pressure <130/80 mmHg, LDL cholesterol <1.8 mmol/L, and HbA1c <7.0%.

The primary outcome at Phase 1 is the ACC/AHA 10-year cardiovascular disease risk estimated by the PREVENT equations. In addition, changes in PREVENT-estimated 10-year ASCVD and heart failure risk, the proportions of participants achieving the prespecified blood pressure, lipid, and glycemic targets, and changes in individual cardiovascular risk factors will also be evaluated.

The primary outcome at Phase 2 is a composite cardiovascular disease outcome including cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, heart failure requiring hospitalization or treatment, and coronary revascularization. Cognitive outcomes will also be assessed, with incident all-cause dementia prespecified as a major secondary outcome.

Studietype

Intervensjonell

Registrering (Antatt)

8252

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Kina
    • Henan
      • Zhengzhou, Henan, Kina
        • Har ikke rekruttert ennå
        • The First Affiliated Hospital of Henan University of Chinese Medicine
        • Ta kontakt med:
    • Inner Mongolia
      • Chifeng, Inner Mongolia, Kina
        • Rekruttering
        • Affiliated Hospital of Chifeng University
        • Ta kontakt med:
      • Tongliao, Inner Mongolia, Kina
        • Har ikke rekruttert ennå
        • Tongliao People's Hospital
        • Ta kontakt med:
    • Jiangsu
      • Kunshan, Jiangsu, Kina
        • Har ikke rekruttert ennå
        • Kunshan Hospital of Chinese Medicine
        • Ta kontakt med:
      • Suzhou, Jiangsu, Kina
        • Har ikke rekruttert ennå
        • The Second Affiliated Hospital of Soochow University
        • Ta kontakt med:
      • Suzhou, Jiangsu, Kina
        • Har ikke rekruttert ennå
        • Suzhou Wujiang District Hospital of Traditional Chinese Medicine
        • Ta kontakt med:
      • Suzhou, Jiangsu, Kina
        • Har ikke rekruttert ennå
        • The Fifth People's Hospital of Wujiang District
        • Ta kontakt med:
      • Taizhou, Jiangsu, Kina
        • Har ikke rekruttert ennå
        • Taixing Second People's Hospital
        • Ta kontakt med:
    • Liaoning
      • Jinzhou, Liaoning, Kina
        • Rekruttering
        • Central Hospital of Jinzhou
        • Ta kontakt med:
      • Panjin, Liaoning, Kina
        • Har ikke rekruttert ennå
        • Panjin Central Hospital
        • Ta kontakt med:
      • Shenyang, Liaoning, Kina
        • Har ikke rekruttert ennå
        • Shengjing Hospital of China Medical University
        • Ta kontakt med:
      • Shenyang, Liaoning, Kina, 110001
        • Rekruttering
        • First Hospital of China Medical University
        • Ta kontakt med:
      • Tieling, Liaoning, Kina
        • Rekruttering
        • Tieling Central Hospital
        • Ta kontakt med:
      • Tieling, Liaoning, Kina
        • Rekruttering
        • Tiemei General Hospital of Liaoning Health Industry Group
        • Ta kontakt med:
    • Shandong
      • Jinan, Shandong, Kina
        • Har ikke rekruttert ennå
        • Shandong Provincial Hospital Affiliated to Shandong First Medical University
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Ingen inngripen: Kontrollgruppe
Vanlig omsorg
Eksperimentell: Experimental
Polypill intervention
Legemiddel: Fixed-Dose Combination Strategy
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.
Andre navn:
  • Polypill Strategy

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
10-year CVD risk
Tidsramme: 12 months
Changes in 10-year CVD risk estimated by the PREVENT equations
12 months
Composite cardiovascular disease outcome
Tidsramme: 36 months
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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
10-year ASCVD risk
Tidsramme: 12 months
Changes in 10-year ASCVD risk estimated by the PREVENT equations
12 months
10-year HF risk
Tidsramme: 12 months
Changes in 10-year HF risk estimated by the PREVENT equations
12 months
Medication adherence
Tidsramme: 12 months
Medication adherence assessed by participant self-report, pill count, or other prespecified adherence measures
12 months
Cost-effectiveness
Tidsramme: 12 months
Data on the costs of CVD risk assessment and management will be collected for both study groups. The cost-effectiveness analysis will estimate the incremental cost per unit reduction in estimated 10-year CVD risk in the intervention group compared with the control group.
12 months
Composite outcome of composite cardiovascular disease outcome or deaths
Tidsramme: 36 months
Record the occurrence of composite outcome of composite cardiovascular disease outcome or deaths
36 months
Macrovascular outcome
Tidsramme: 36 months
Record the occurrence of any of the following: stroke, myocardial infarction, heart failure requiring hospitalization or treatment, aortic dissection, any cardiovascular revascularization procedures, or cardiovascular death
36 months
Major coronary artery diseases
Tidsramme: 36 months
Record the occurrence of any of the following: myocardial infarction, revascularization of coronary arteries, or deaths due to coronary artery diseases
36 months
New-onset chronic kidney disease or progression of chronic kidney disease
Tidsramme: 36 months
Record the occurrence of new-onset chronic kidney disease or progression of chronic kidney disease
36 months
Medication adherence
Tidsramme: 36 months
Medication adherence assessed by participant self-report, pill count, or other prespecified adherence measures
36 months
Health related quality of life
Tidsramme: 36 months
Health-related quality of life will be assessed by the Five-Level Version of the EQ-5D (EQ-5D-5L). In this questionnaire, 5 dimensions are measured in 5 items: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. A 5-point Likert scale ranging from "no problems" to "extreme problems" is used for every dimension, with higher scores reflecting more problems in a dimension. A VAS ranging from 0 to 100 (0 = "The best health you can imagine" to 100 = "The worst health you can imagine") is applied as well, with higher scores indicating a better health state as perceived by the patient.
36 months
Cost-effectiveness
Tidsramme: 36 months
Cost-effectiveness assessed by the incremental cost-effectiveness ratio, expressed as the incremental cost per quality-adjusted life-year gained. Quality-adjusted life-years will be estimated from health utilities derived using the EQ-5D-5L questionnaire.
36 months
Major secondary endpoint: All-cause dementia
Tidsramme: 36 months
Record the occurrence of 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
Tidsramme: 12 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
The proportions of participants achieving the prespecified blood pressure, LDL-C, and HbA1c targets, individually and jointly
Tidsramme: 12 months
The proportions of participants achieving the prespecified targets for blood pressure (systolic blood pressure <130 mmHg and diastolic blood pressure <80 mmHg), LDL-C (<1.8 mmol/L), and HbA1c (<7.0%), individually and jointly
12 months
Blood pressure, LDL-C, and HbA1c
Tidsramme: 12 months
Changes in systolic and diastolic blood pressure, LDL-C, and HbA1c
12 months
Hierarchical composite of all-cause mortality, nonfatal cardiovascular events, and improvement in 10-year cardiovascular disease risk estimated by the PREVENT equations
Tidsramme: 36 months
Hierarchical composite of all-cause mortality, nonfatal cardiovascular events, and improvement in 10-year cardiovascular disease risk estimated by the PREVENT equations
36 months
The proportions of participants achieving the prespecified blood pressure, LDL-C, and HbA1c targets, individually and jointly
Tidsramme: 36 months
The proportions of participants achieving the prespecified targets for blood pressure (systolic blood pressure <130 mmHg and diastolic blood pressure <80 mmHg), LDL-C (<1.8 mmol/L), and HbA1c (<7.0%), individually and jointly
36 months
Blood pressure, LDL-C, and HbA1c
Tidsramme: 36 months
Changes in systolic and diastolic blood pressure, LDL-C, and HbA1c
36 months
Myocardial infarction
Tidsramme: 36 months
Record the occurrence of myocardial infarction
36 months
Stroke
Tidsramme: 36 months
Record the occurrence of stroke
36 months
Ischemic stroke
Tidsramme: 36 months
Record the occurrence of ischemic stroke
36 months
Hemorrhagic stoke
Tidsramme: 36 months
Record the occurrence of hemorrhagic stroke
36 months
Heart failure requiring hospitalization or treatment
Tidsramme: 36 months
Record the occurrence of heart failure requiring hospitalization or treatment
36 months
Coronary revascularization
Tidsramme: 36 months
Record the occurrence of coronary revascularization
36 months
Cardiovascular disease death
Tidsramme: 36 months
Record the occurrence of cardiovascular disease death
36 months
All-cause death
Tidsramme: 36 months
Record the occurrence of all-cause death
36 months
Microvascular outcomes
Tidsramme: 36 months
Record the occurrence of microvascular complications (e.g., diabetic kidney disease and diabetic peripheral neuropathy)
36 months
Mild cognitive impairment
Tidsramme: 36 months
Record the occurrence of mild cognitive impairment
36 months
Composite outcome of dementia and mild cognitive impairment
Tidsramme: 36 months
Record the occurrence of the composite outcome of dementia and mild cognitive impairment
36 months
Composite outcome of dementia and all-cause death
Tidsramme: 36 months
Record the occurrence of the composite outcome of dementia and all-cause death
36 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

China Medical University, China

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

11. juli 2026

Primær fullføring (Antatt)

31. desember 2029

Studiet fullført (Antatt)

1. mars 2030

Datoer for studieregistrering

Først innsendt

21. juni 2026

Først innsendt som oppfylte QC-kriteriene

25. juni 2026

Først lagt ut (Faktiske)

1. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

16. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

12. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CMU-polypill

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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