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Polypills Approach for Multiple Cardiovascular Risk Factors (PACIF)

2026年9月12日 更新者：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.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

8252

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 中国
    • Henan
      • Zhengzhou、Henan、中国
        • 尚未招聘
        • The First Affiliated Hospital of Henan University of Chinese Medicine
        • 接触：
    • Inner Mongolia
      • Chifeng、Inner Mongolia、中国
        • 招聘中
        • Affiliated Hospital of Chifeng University
        • 接触：
      • Tongliao、Inner Mongolia、中国
        • 尚未招聘
        • Tongliao People's Hospital
        • 接触：
    • Jiangsu
      • Kunshan、Jiangsu、中国
        • 尚未招聘
        • Kunshan Hospital of Chinese Medicine
        • 接触：
      • Suzhou、Jiangsu、中国
        • 尚未招聘
        • The Second Affiliated Hospital of Soochow University
        • 接触：
      • Suzhou、Jiangsu、中国
        • 尚未招聘
        • Suzhou Wujiang District Hospital of Traditional Chinese Medicine
        • 接触：
      • Suzhou、Jiangsu、中国
        • 尚未招聘
        • The Fifth People's Hospital of Wujiang District
        • 接触：
      • Taizhou、Jiangsu、中国
        • 尚未招聘
        • Taixing Second People's Hospital
        • 接触：
    • Liaoning
      • Jinzhou、Liaoning、中国
        • 招聘中
        • Central Hospital of Jinzhou
        • 接触：
      • Panjin、Liaoning、中国
        • 尚未招聘
        • Panjin Central Hospital
        • 接触：
      • Shenyang、Liaoning、中国
        • 尚未招聘
        • Shengjing Hospital of China Medical University
        • 接触：
      • Shenyang、Liaoning、中国、110001
        • 招聘中
        • First Hospital of China Medical University
        • 接触：
      • Tieling、Liaoning、中国
        • 招聘中
        • Tieling Central Hospital
        • 接触：
      • Tieling、Liaoning、中国
        • 招聘中
        • Tiemei General Hospital of Liaoning Health Industry Group
        • 接触：
    • Shandong
      • Jinan、Shandong、中国
        • 尚未招聘
        • Shandong Provincial Hospital Affiliated to Shandong First Medical University
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
无干预：控制组
日常护理
实验性的：Experimental
Polypill intervention
药品：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.
其他名称：
  • Polypill Strategy

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
10-year CVD risk
大体时间：12 months
Changes in 10-year CVD risk estimated by the PREVENT equations
12 months
Composite cardiovascular disease outcome
大体时间：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

次要结果测量

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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

China Medical University, China

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年7月11日

初级完成 (估计的)

2029年12月31日

研究完成 (估计的)

2030年3月1日

研究注册日期

首次提交

2026年6月21日

首先提交符合 QC 标准的

2026年6月25日

首次发布 (实际的)

2026年7月1日

研究记录更新

最后更新发布 (实际的)

2026年9月16日

上次提交的符合 QC 标准的更新

2026年9月12日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • CMU-polypill

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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