Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Polypills Approach for Multiple Cardiovascular Risk Factors (PACIF)

12 de septiembre de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

8252

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Porcelana
    • Henan
      • Zhengzhou, Henan, Porcelana
        • Aún no reclutando
        • The First Affiliated Hospital of Henan University of Chinese Medicine
        • Contacto:
    • Inner Mongolia
      • Chifeng, Inner Mongolia, Porcelana
        • Reclutamiento
        • Affiliated Hospital of Chifeng University
        • Contacto:
      • Tongliao, Inner Mongolia, Porcelana
        • Aún no reclutando
        • Tongliao People's Hospital
        • Contacto:
    • Jiangsu
      • Kunshan, Jiangsu, Porcelana
        • Aún no reclutando
        • Kunshan Hospital of Chinese Medicine
        • Contacto:
          • Hengshan Shen
          • Número de teléfono: +86 13962637574
          • Correo electrónico: 847658065@qq.com
      • Suzhou, Jiangsu, Porcelana
        • Aún no reclutando
        • The Second Affiliated Hospital of Soochow University
        • Contacto:
      • Suzhou, Jiangsu, Porcelana
        • Aún no reclutando
        • Suzhou Wujiang District Hospital of Traditional Chinese Medicine
        • Contacto:
          • Wangfeng Qian
          • Número de teléfono: +86 13771692578
          • Correo electrónico: wfss873@sina.com
      • Suzhou, Jiangsu, Porcelana
        • Aún no reclutando
        • The Fifth People's Hospital of Wujiang District
        • Contacto:
      • Taizhou, Jiangsu, Porcelana
        • Aún no reclutando
        • Taixing Second People's Hospital
        • Contacto:
          • Ligong Ji
          • Número de teléfono: +86 13815979287
          • Correo electrónico: 420643682@qq.com
    • Liaoning
      • Jinzhou, Liaoning, Porcelana
        • Reclutamiento
        • Central Hospital of Jinzhou
        • Contacto:
      • Panjin, Liaoning, Porcelana
        • Aún no reclutando
        • Panjin Central Hospital
        • Contacto:
          • Qiong Zhang
          • Número de teléfono: +86 15504272626
          • Correo electrónico: yoner6789@163.com
      • Shenyang, Liaoning, Porcelana
        • Aún no reclutando
        • Shengjing Hospital of China Medical University
        • Contacto:
          • Anhua Wu
          • Número de teléfono: +86 18900925766
          • Correo electrónico: ahwu@cmu.edu.cn
      • Shenyang, Liaoning, Porcelana, 110001
        • Reclutamiento
        • First Hospital of China Medical University
        • Contacto:
          • Guozhe Sun
          • Número de teléfono: +86 15040292137
          • Correo electrónico: gzhsun66@163.com
      • Tieling, Liaoning, Porcelana
        • Reclutamiento
        • Tieling Central Hospital
        • Contacto:
          • Caixia Yang
          • Número de teléfono: +86 13704109696
          • Correo electrónico: 2624603253@qq.com
      • Tieling, Liaoning, Porcelana
        • Reclutamiento
        • Tiemei General Hospital of Liaoning Health Industry Group
        • Contacto:
    • Shandong
      • Jinan, Shandong, Porcelana
        • Aún no reclutando
        • Shandong Provincial Hospital Affiliated to Shandong First Medical University
        • Contacto:
          • Xiaoming Zhou
          • Número de teléfono: +86 15168887283
          • Correo electrónico: sdslyy@yeah.net

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Sin intervención: Grupo de control
Cuidado usual
Experimental: Experimental
Polypill intervention
Droga: 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.
Otros nombres:
  • Polypill Strategy

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
10-year CVD risk
Periodo de tiempo: 12 months
Changes in 10-year CVD risk estimated by the PREVENT equations
12 months
Composite cardiovascular disease outcome
Periodo de tiempo: 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

Medidas de resultado secundarias

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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

China Medical University, China

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

11 de julio de 2026

Finalización primaria (Estimado)

31 de diciembre de 2029

Finalización del estudio (Estimado)

1 de marzo de 2030

Fechas de registro del estudio

Enviado por primera vez

21 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

25 de junio de 2026

Publicado por primera vez (Actual)

1 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

16 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

12 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • CMU-polypill

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Suscribir