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Polypills Approach for Multiple Cardiovascular Risk Factors (PACIF)

25. Juni 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

8252

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • 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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Kein Eingriff: Kontrollgruppe
Übliche Pflege
Experimental: Experimental
Polypill intervention
Arzneimittel: 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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
10-year CVD risk
Zeitfenster: 12 months
Changes in 10-year CVD risk estimated by the PREVENT equations
12 months
Composite cardiovascular disease outcome
Zeitfenster: 36 months
Record the occurrence of newly diagnosed composite cardiovascular disease
36 months

Sekundäre Ergebnismessungen

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

China Medical University, China

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juli 2026

Primärer Abschluss (Geschätzt)

31. Dezember 2029

Studienabschluss (Geschätzt)

1. März 2030

Studienanmeldedaten

Zuerst eingereicht

21. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

25. Juni 2026

Zuerst gepostet (Tatsächlich)

1. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

1. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

25. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • CMU-polypill

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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