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Polypills Approach for Multiple Cardiovascular Risk Factors (PACIF)

12. září 2026 aktualizováno: 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.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

8252

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Čína
    • Henan
      • Zhengzhou, Henan, Čína
        • Zatím nenabíráme
        • The First Affiliated Hospital of Henan University of Chinese Medicine
        • Kontakt:
    • Inner Mongolia
      • Chifeng, Inner Mongolia, Čína
        • Nábor
        • Affiliated Hospital of Chifeng University
        • Kontakt:
      • Tongliao, Inner Mongolia, Čína
        • Zatím nenabíráme
        • Tongliao People's Hospital
        • Kontakt:
    • Jiangsu
      • Kunshan, Jiangsu, Čína
        • Zatím nenabíráme
        • Kunshan Hospital of Chinese Medicine
        • Kontakt:
      • Suzhou, Jiangsu, Čína
        • Zatím nenabíráme
        • The Second Affiliated Hospital of Soochow University
        • Kontakt:
      • Suzhou, Jiangsu, Čína
        • Zatím nenabíráme
        • Suzhou Wujiang District Hospital of Traditional Chinese Medicine
        • Kontakt:
      • Suzhou, Jiangsu, Čína
        • Zatím nenabíráme
        • The Fifth People's Hospital of Wujiang District
        • Kontakt:
      • Taizhou, Jiangsu, Čína
        • Zatím nenabíráme
        • Taixing Second People's Hospital
        • Kontakt:
    • Liaoning
      • Jinzhou, Liaoning, Čína
        • Nábor
        • Central Hospital of Jinzhou
        • Kontakt:
      • Panjin, Liaoning, Čína
        • Zatím nenabíráme
        • Panjin Central Hospital
        • Kontakt:
      • Shenyang, Liaoning, Čína
        • Zatím nenabíráme
        • Shengjing Hospital of China Medical University
        • Kontakt:
      • Shenyang, Liaoning, Čína, 110001
        • Nábor
        • First Hospital of China Medical University
        • Kontakt:
      • Tieling, Liaoning, Čína
        • Nábor
        • Tieling Central Hospital
        • Kontakt:
      • Tieling, Liaoning, Čína
        • Nábor
        • Tiemei General Hospital of Liaoning Health Industry Group
        • Kontakt:
    • Shandong
      • Jinan, Shandong, Čína
        • Zatím nenabíráme
        • Shandong Provincial Hospital Affiliated to Shandong First Medical University
        • Kontakt:
          • Xiaoming Zhou
          • Telefonní číslo: +86 15168887283
          • E-mail: sdslyy@yeah.net

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Žádný zásah: Kontrolní skupina
Obvyklá péče
Experimentální: Experimental
Polypill intervention
Lék: 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.
Ostatní jména:
  • Polypill Strategy

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
10-year CVD risk
Časové okno: 12 months
Changes in 10-year CVD risk estimated by the PREVENT equations
12 months
Composite cardiovascular disease outcome
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
10-year ASCVD risk
Časové okno: 12 months
Changes in 10-year ASCVD risk estimated by the PREVENT equations
12 months
10-year HF risk
Časové okno: 12 months
Changes in 10-year HF risk estimated by the PREVENT equations
12 months
Medication adherence
Časové okno: 12 months
Medication adherence assessed by participant self-report, pill count, or other prespecified adherence measures
12 months
Cost-effectiveness
Časové okno: 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
Časové okno: 36 months
Record the occurrence of composite outcome of composite cardiovascular disease outcome or deaths
36 months
Macrovascular outcome
Časové okno: 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
Časové okno: 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
Časové okno: 36 months
Record the occurrence of new-onset chronic kidney disease or progression of chronic kidney disease
36 months
Medication adherence
Časové okno: 36 months
Medication adherence assessed by participant self-report, pill count, or other prespecified adherence measures
36 months
Health related quality of life
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 36 months
Changes in systolic and diastolic blood pressure, LDL-C, and HbA1c
36 months
Myocardial infarction
Časové okno: 36 months
Record the occurrence of myocardial infarction
36 months
Stroke
Časové okno: 36 months
Record the occurrence of stroke
36 months
Ischemic stroke
Časové okno: 36 months
Record the occurrence of ischemic stroke
36 months
Hemorrhagic stoke
Časové okno: 36 months
Record the occurrence of hemorrhagic stroke
36 months
Heart failure requiring hospitalization or treatment
Časové okno: 36 months
Record the occurrence of heart failure requiring hospitalization or treatment
36 months
Coronary revascularization
Časové okno: 36 months
Record the occurrence of coronary revascularization
36 months
Cardiovascular disease death
Časové okno: 36 months
Record the occurrence of cardiovascular disease death
36 months
All-cause death
Časové okno: 36 months
Record the occurrence of all-cause death
36 months
Microvascular outcomes
Časové okno: 36 months
Record the occurrence of microvascular complications (e.g., diabetic kidney disease and diabetic peripheral neuropathy)
36 months
Mild cognitive impairment
Časové okno: 36 months
Record the occurrence of mild cognitive impairment
36 months
Composite outcome of dementia and mild cognitive impairment
Časové okno: 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
Časové okno: 36 months
Record the occurrence of the composite outcome of dementia and all-cause death
36 months

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

China Medical University, China

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

11. července 2026

Primární dokončení (Odhadovaný)

31. prosince 2029

Dokončení studie (Odhadovaný)

1. března 2030

Termíny zápisu do studia

První předloženo

21. června 2026

První předloženo, které splnilo kritéria kontroly kvality

25. června 2026

První zveřejněno (Aktuální)

1. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

16. září 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

12. září 2026

Naposledy ověřeno

1. září 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

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Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

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Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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