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Polypills Approach for Multiple Cardiovascular Risk Factors (PACIF)

25 juni 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Geneesmiddel: Fixed-Dose Combination Strategy

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

8252

Fase

Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

Volwassen
Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Primair doel: Behandeling
Toewijzing: Gerandomiseerd
Interventioneel model: Parallelle opdracht
Masker: Enkel

Aantal wapens

Wapens en interventies

Deelnemersgroep / Arm	Interventie / Behandeling
Geen tussenkomst: Controlegroep Gebruikelijke zorg
Experimenteel: Experimental Polypill intervention	Geneesmiddel: 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. Andere namen: Polypill Strategy

Deelnemersgroep / Arm

Interventie / Behandeling

Geen tussenkomst: Controlegroep

Gebruikelijke zorg

Experimenteel: Experimental

Polypill intervention

Geneesmiddel: 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.

Andere namen:

Polypill Strategy

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
10-year CVD risk Tijdsspanne: 12 months	Changes in 10-year CVD risk estimated by the PREVENT equations	12 months
Composite cardiovascular disease outcome Tijdsspanne: 36 months	Record the occurrence of newly diagnosed composite cardiovascular disease	36 months

Secundaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Major secondary endpoint: All-cause dementia Tijdsspanne: 36 months	Record all-cause dementia	36 months
10-year ASCVD risk Tijdsspanne: 12 months	Changes in 10-year ASCVD risk estimated by the PREVENT equations	12 months
10-year HF risk Tijdsspanne: 12 months	Changes in 10-year HF risk estimated by the PREVENT equations	12 months
The proportion of patients achieved blood pressure target Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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) Tijdsspanne: 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 Tijdsspanne: 12 months	Changes in systolic and diastolic blood pressure	12 months
LDL-C Tijdsspanne: 12 months	Changes in LDL-C	12 months
HbA1c Tijdsspanne: 12 months	Changes in HbA1c	12 months
Medication adherence Tijdsspanne: 12 months	Medication adherence assessed by participant self-report, pill count, or other prespecified adherence measures	12 months
Cost-effectiveness Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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) Tijdsspanne: 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 Tijdsspanne: 36 months	Changes in systolic and diastolic blood pressure	36 months
LDL-C Tijdsspanne: 36 months	Changes in LDL-C	36 months
HbA1c Tijdsspanne: 36 months	Changes in HbA1c	36 months
Composite outcome of composite cardiovascular disease outcome or deaths Tijdsspanne: 36 months	Record the occurrence of composite outcome of composite cardiovascular disease outcome or deaths	36 months
Macrovascular outcome Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 36 months	Number of newly diagnosed myocardial infarction	36 months
Stroke Tijdsspanne: 36 months	Number of newly diagnosed stroke	36 months
Ischemic stroke Tijdsspanne: 36 months	Number of newly diagnosed ischemic stroke	36 months
Hemorrhagic stoke Tijdsspanne: 36 months	Number of newly diagnosed hemorrhagic stroke	36 months
Heart failure requiring hospitalization or treatment Tijdsspanne: 36 months	Number of patients with newly diagnosed heart failure requiring hospitalization or treatment	36 months
Cardiovascular disease death Tijdsspanne: 36 months	Number of cardiovascular disease death	36 months
All-cause death Tijdsspanne: 36 months	Number of all-cause death	36 months
Aortic dissection Tijdsspanne: 36 months	Number of newly diagnosed aortic dissection	36 months
Cancer Tijdsspanne: 36 months	Number of newly diagnosed cancer	36 months
New-onset chronic kidney disease or progression of chronic kidney disease Tijdsspanne: 36 months	Record the occurrence of new-onset chronic kidney disease or progression of chronic kidney disease	36 months
Medication adherence Tijdsspanne: 36 months	Medication adherence assessed by participant self-report, pill count, or other prespecified adherence measures	36 months
Mild cognitive impairment Tijdsspanne: 36 months	Record mild cognitive impairment	36 months
Composite outcome of dementia and mild cognitive impairment Tijdsspanne: 36 months	Record the composite outcome of dementia and mild cognitive impairment	36 months
Health related quality of life Tijdsspanne: 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 Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

China Medical University, China

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juli 2026

Primaire voltooiing (Geschat)

31 december 2029

Studie voltooiing (Geschat)

1 maart 2030

Studieregistratiedata

Eerst ingediend

21 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

25 juni 2026

Eerst geplaatst (Werkelijk)

1 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

1 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

25 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

CMU-polypill

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Polypills Approach for Multiple Cardiovascular Risk Factors (PACIF)