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Polypills Approach for Multiple Cardiovascular Risk Factors (PACIF)

25. června 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 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Lék: Fixed-Dose Combination Strategy

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. The trial will recruit an estimated 8,252 participants aged 50 to 75 years who have hypertension, dyslipidemia, and 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 six fixed-dose formulations, including three antihypertensive formulations, two lipid-lowering formulations, and one glucose-lowering formulation. The antihypertensive component will be titrated using prespecified dose combinations, including olmesartan medoxomil/amlodipine and indapamide, until the blood pressure target is achieved. Lipid-lowering therapy will be initiated with rosuvastatin plus ezetimibe, with dose reduction of the rosuvastatin component in participants who are intolerant to the initial statin dose. Glucose-lowering therapy will include dapagliflozin as the prespecified study medication. Treatment targets are defined as systolic blood pressure <130 mmHg and diastolic blood pressure <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, the proportions of participants achieving the prespecified blood pressure, lipid, and glycemic targets will also be evaluated. The primary outcome at phase 2 is composite cardiovascular disease events, including myocardial infarction, stroke, heart failure requiring hospitalization or treatment, or cardiovascular death. Cognitive function will also be assessed, with incident dementia prespecified as a major secondary endpoint.

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
- Inner Mongolia
  - Chifeng, Inner Mongolia, Čína
    - Affiliated Hospital of Chifeng University
- Jiangsu
  - Kunshan, Jiangsu, Čína
    - Kunshan Hospital of Chinese Medicine
  - Suzhou, Jiangsu, Čína
    - The Second Affiliated Hospital of Soochow University
  - Suzhou, Jiangsu, Čína
    - Suzhou Wujiang District Hospital of Traditional Chinese Medicine
  - Suzhou, Jiangsu, Čína
    - The Fifth People's Hospital of Wujiang District
  - Taizhou, Jiangsu, Čína
    - Taixing Second People's Hospital
- Liaoning
  - Jinzhou, Liaoning, Čína
    - Central Hospital of Jinzhou
  - Panjin, Liaoning, Čína
    - Panjin Central Hospital
  - Shenyang, Liaoning, Čína
    - Shengjing Hospital Of China Medical University
  - Shenyang, Liaoning, Čína
    - First Hospital of China Medical University
  - Tieling, Liaoning, Čína
    - Tiemei General Hospital of Liaoning Health Industry Group
- Shandong
  - Jinan, Shandong, Čína
    - Shandong Provincial Hospital Affiliated to Shandong First Medical University

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

Popis

Inclusion Criteria:

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

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 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
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

Počet zbraní

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 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. Ostatní jména: Polypill Strategy

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 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.

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 newly diagnosed composite cardiovascular disease	36 months

Sekundární výstupní opatření

Měření výsledku	Popis opatření	Časové okno
Major secondary endpoint: All-cause dementia Časové okno: 36 months	Record all-cause dementia	36 months
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
The proportion of patients achieved blood pressure target Časové okno: 12 months	The proportion of patients achieved blood pressure target (systolic blood pressure <130 mmHg and diastolic blood pressure <80 mmHg)	12 months
The proportion of patients achieved LDL-C target Časové okno: 12 months	The proportion of patients achieved LDL-C target (LDL-C <1.8 mmol/L)	12 months
The proportion of patients achieved HbA1c target Časové okno: 12 months	The proportion of patients achieved HbA1c target (HbA1c <7.0%)	12 months
The proportion of patients achieved all three targets (blood pressure, LDL-C, and HbA1c) Časové okno: 12 months	The proportion of patients achieved all three targets (systolic blood pressure <130 mmHg and diastolic blood pressure <80 mmHg, LDL-C <1.8 mmol/L, and HbA1c <7.0%)	12 months
Blood pressure Časové okno: 12 months	Changes in systolic and diastolic blood pressure	12 months
LDL-C Časové okno: 12 months	Changes in LDL-C	12 months
HbA1c Časové okno: 12 months	Changes in HbA1c	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
The proportion of patients achieved blood pressure target Časové okno: 36 months	The proportion of patients achieved blood pressure target (systolic blood pressure <130 mmHg and diastolic blood pressure <80 mmHg)	36 months
The proportion of patients achieved LDL-C target Časové okno: 36 months	The proportion of patients achieved LDL-C target (LDL-C <1.8 mmol/L)	36 months
The proportion of patients achieved HbA1c target Časové okno: 36 months	The proportion of patients achieved HbA1c target (HbA1c <7.0%)	36 months
The proportion of patients achieved all three targets (blood pressure, LDL-C, and HbA1c) Časové okno: 36 months	The proportion of patients achieved all three targets (systolic blood pressure <130 mmHg and diastolic blood pressure <80 mmHg, LDL-C <1.8 mmol/L, and HbA1c <7.0%)	36 months
Blood pressure Časové okno: 36 months	Changes in systolic and diastolic blood pressure	36 months
LDL-C Časové okno: 36 months	Changes in LDL-C	36 months
HbA1c Časové okno: 36 months	Changes in HbA1c	36 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
Myocardial infarction Časové okno: 36 months	Number of newly diagnosed myocardial infarction	36 months
Stroke Časové okno: 36 months	Number of newly diagnosed stroke	36 months
Ischemic stroke Časové okno: 36 months	Number of newly diagnosed ischemic stroke	36 months
Hemorrhagic stoke Časové okno: 36 months	Number of newly diagnosed hemorrhagic stroke	36 months
Heart failure requiring hospitalization or treatment Časové okno: 36 months	Number of patients with newly diagnosed heart failure requiring hospitalization or treatment	36 months
Cardiovascular disease death Časové okno: 36 months	Number of cardiovascular disease death	36 months
All-cause death Časové okno: 36 months	Number of all-cause death	36 months
Aortic dissection Časové okno: 36 months	Number of newly diagnosed aortic dissection	36 months
Cancer Časové okno: 36 months	Number of newly diagnosed cancer	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
Mild cognitive impairment Časové okno: 36 months	Record mild cognitive impairment	36 months
Composite outcome of dementia and mild cognitive impairment Časové okno: 36 months	Record the composite outcome of dementia and mild cognitive impairment	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

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 (Odhadovaný)

1. 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)

1. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

25. června 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

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Polypills Approach for Multiple Cardiovascular Risk Factors (PACIF)