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Polypills Approach for Multiple Cardiovascular Risk Factors (PACIF)

2026년 9월 12일 업데이트: 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.

연구 개요

상태

모병

정황

개입 / 치료

의약품: Fixed-Dose Combination Strategy

상세 설명

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.

연구 유형

중재적

등록 (추정된)

8252

단계

해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

중국
- Henan
  - Zhengzhou, Henan, 중국
    - 아직 모집하지 않음
    - The First Affiliated Hospital of Henan University of Chinese Medicine
    - 연락하다:
      
      Xincan Liu
      
      전화번호: +86 13203825657
      
      이메일: Liuxincan103@163.com
- Inner Mongolia
  - Chifeng, Inner Mongolia, 중국
    - 모병
    - Affiliated Hospital of Chifeng University
    - 연락하다:
      
      Xuchen Han
      
      전화번호: +86 15504766986
      
      이메일: hanxuchen2004@163.com
  - Tongliao, Inner Mongolia, 중국
    - 아직 모집하지 않음
    - Tongliao People's Hospital
    - 연락하다:
      
      Kai Zheng
      
      전화번호: +86 15004963990
      
      이메일: udbmnm2012@163.com
- Jiangsu
  - Kunshan, Jiangsu, 중국
    - 아직 모집하지 않음
    - Kunshan Hospital of Chinese Medicine
    - 연락하다:
      
      Hengshan Shen
      
      전화번호: +86 13962637574
      
      이메일: 847658065@qq.com
  - Suzhou, Jiangsu, 중국
    - 아직 모집하지 않음
    - The Second Affiliated Hospital of Soochow University
    - 연락하다:
      
      Jijun Shi
      
      전화번호: +86 18934593776
      
      이메일: shijijun2008@126.com
  - Suzhou, Jiangsu, 중국
    - 아직 모집하지 않음
    - Suzhou Wujiang District Hospital of Traditional Chinese Medicine
    - 연락하다:
      
      Wangfeng Qian
      
      전화번호: +86 13771692578
      
      이메일: wfss873@sina.com
  - Suzhou, Jiangsu, 중국
    - 아직 모집하지 않음
    - The Fifth People's Hospital of Wujiang District
    - 연락하다:
      
      Jun Li
      
      전화번호: +86 13913731272
      
      이메일: lijun19801005@163.com
  - Taizhou, Jiangsu, 중국
    - 아직 모집하지 않음
    - Taixing Second People's Hospital
    - 연락하다:
      
      Ligong Ji
      
      전화번호: +86 13815979287
      
      이메일: 420643682@qq.com
- Liaoning
  - Jinzhou, Liaoning, 중국
    - 모병
    - Central Hospital of Jinzhou
    - 연락하다:
      
      Shuai Jiang
      
      전화번호: +86 13897854774
      
      이메일: 13897854774@163.com
  - Panjin, Liaoning, 중국
    - 아직 모집하지 않음
    - Panjin Central Hospital
    - 연락하다:
      
      Qiong Zhang
      
      전화번호: +86 15504272626
      
      이메일: yoner6789@163.com
  - Shenyang, Liaoning, 중국
    - 아직 모집하지 않음
    - Shengjing Hospital of China Medical University
    - 연락하다:
      
      Anhua Wu
      
      전화번호: +86 18900925766
      
      이메일: ahwu@cmu.edu.cn
  - Shenyang, Liaoning, 중국, 110001
    - 모병
    - First Hospital of China Medical University
    - 연락하다:
      
      Guozhe Sun
      
      전화번호: +86 15040292137
      
      이메일: gzhsun66@163.com
  - Tieling, Liaoning, 중국
    - 모병
    - Tieling Central Hospital
    - 연락하다:
      
      Caixia Yang
      
      전화번호: +86 13704109696
      
      이메일: 2624603253@qq.com
  - Tieling, Liaoning, 중국
    - 모병
    - Tiemei General Hospital of Liaoning Health Industry Group
    - 연락하다:
      
      Geng Wang
      
      전화번호: +86 15542052188
      
      이메일: 15542052188@163.com
- Shandong
  - Jinan, Shandong, 중국
    - 아직 모집하지 않음
    - Shandong Provincial Hospital Affiliated to Shandong First Medical University
    - 연락하다:
      
      Xiaoming Zhou
      
      전화번호: +86 15168887283
      
      이메일: sdslyy@yeah.net

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

성인
고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

주 목적: 치료
할당: 무작위
중재 모델: 병렬 할당
마스킹: 하나의

무기와 개입

참가자 그룹 / 팔 참가자 그룹 / 팔 시험 프로토콜에 따라 특정 중재/치료를 받거나 중재를 받지 않는 임상 시험 참가자 그룹 또는 하위 그룹입니다.	개입 / 치료 개입 / 치료 임상 연구의 초점이 되는 프로세스 또는 작업입니다. 개입에는 약물, 의료 기기, 절차, 백신 및 조사 중이거나 이미 사용 가능한 기타 제품이 포함됩니다. 개입에는 교육이나 식이요법 및 운동 수정과 같은 비침습적 접근법도 포함될 수 있습니다.
간섭 없음: 대조군 평소 케어
실험적: Experimental Polypill intervention	의약품: 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. 다른 이름들: Polypill Strategy

참가자 그룹 / 팔

개입 / 치료

간섭 없음: 대조군

평소 케어

실험적: Experimental

Polypill intervention

의약품: 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.

다른 이름들:

Polypill Strategy

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	측정값 설명	기간
10-year CVD risk 기간: 12 months	Changes in 10-year CVD risk estimated by the PREVENT equations	12 months
Composite cardiovascular disease outcome 기간: 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

2차 결과 측정

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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

China Medical University, China

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 7월 11일

기본 완료 (추정된)

2029년 12월 31일

연구 완료 (추정된)

2030년 3월 1일

연구 등록 날짜

최초 제출

2026년 6월 21일

QC 기준을 충족하는 최초 제출

2026년 6월 25일

처음 게시됨 (실제)

2026년 7월 1일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 16일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 12일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

CMU-polypill

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

Polypills Approach for Multiple Cardiovascular Risk Factors (PACIF)