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Polypills Approach for Multiple Cardiovascular Risk Factors (PACIF)

12 septembre 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

8252

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Chine
    • Henan
      • Zhengzhou, Henan, Chine
        • Pas encore de recrutement
        • The First Affiliated Hospital of Henan University of Chinese Medicine
        • Contact:
    • Inner Mongolia
      • Chifeng, Inner Mongolia, Chine
        • Recrutement
        • Affiliated Hospital of Chifeng University
        • Contact:
      • Tongliao, Inner Mongolia, Chine
        • Pas encore de recrutement
        • Tongliao People's Hospital
        • Contact:
    • Jiangsu
      • Kunshan, Jiangsu, Chine
        • Pas encore de recrutement
        • Kunshan Hospital of Chinese Medicine
        • Contact:
          • Hengshan Shen
          • Numéro de téléphone: +86 13962637574
          • E-mail: 847658065@qq.com
      • Suzhou, Jiangsu, Chine
        • Pas encore de recrutement
        • The Second Affiliated Hospital of Soochow University
        • Contact:
      • Suzhou, Jiangsu, Chine
        • Pas encore de recrutement
        • Suzhou Wujiang District Hospital of Traditional Chinese Medicine
        • Contact:
          • Wangfeng Qian
          • Numéro de téléphone: +86 13771692578
          • E-mail: wfss873@sina.com
      • Suzhou, Jiangsu, Chine
        • Pas encore de recrutement
        • The Fifth People's Hospital of Wujiang District
        • Contact:
      • Taizhou, Jiangsu, Chine
        • Pas encore de recrutement
        • Taixing Second People's Hospital
        • Contact:
    • Liaoning
      • Jinzhou, Liaoning, Chine
        • Recrutement
        • Central Hospital of Jinzhou
        • Contact:
      • Panjin, Liaoning, Chine
        • Pas encore de recrutement
        • Panjin Central Hospital
        • Contact:
      • Shenyang, Liaoning, Chine
        • Pas encore de recrutement
        • Shengjing Hospital of China Medical University
        • Contact:
      • Shenyang, Liaoning, Chine, 110001
        • Recrutement
        • First Hospital of China Medical University
        • Contact:
      • Tieling, Liaoning, Chine
        • Recrutement
        • Tieling Central Hospital
        • Contact:
      • Tieling, Liaoning, Chine
        • Recrutement
        • Tiemei General Hospital of Liaoning Health Industry Group
        • Contact:
    • Shandong
      • Jinan, Shandong, Chine
        • Pas encore de recrutement
        • Shandong Provincial Hospital Affiliated to Shandong First Medical University
        • Contact:
          • Xiaoming Zhou
          • Numéro de téléphone: +86 15168887283
          • E-mail: sdslyy@yeah.net

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Aucune intervention: Groupe de contrôle
Soins habituels
Expérimental: Experimental
Polypill intervention
Médicament: 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.
Autres noms:
  • Polypill Strategy

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
10-year CVD risk
Délai: 12 months
Changes in 10-year CVD risk estimated by the PREVENT equations
12 months
Composite cardiovascular disease outcome
Délai: 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

Mesures de résultats secondaires

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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

China Medical University, China

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

11 juillet 2026

Achèvement primaire (Estimé)

31 décembre 2029

Achèvement de l'étude (Estimé)

1 mars 2030

Dates d'inscription aux études

Première soumission

21 juin 2026

Première soumission répondant aux critères de contrôle qualité

25 juin 2026

Première publication (Réel)

1 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

16 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

12 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • CMU-polypill

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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