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A Trial to Evaluate Efficacy of Heart-protecting Musk Pill

2014년 12월 17일 업데이트: Shanghai Hutchison Pharmaceuticals Limited

A Randomized, Double-blind, Multi-centered, Placebo-controlled Trial to Examine Effects of Heart-protecting Musk Pill on Clinical Outcome in Patients With Chronic Stable Coronary Artery Disease

Title:

A randomized, double-blind, multi-centered, placebo-controlled trial to examine effects of of Heart-protecting Musk Pill on clinical outcomes in patients with chronic stable coronary artery disease

Objective:

To examine effects of of Heart-protecting Musk Pill, a traditional Chinese medicine, on clinical outcomes in patients with chronic stable coronary artery disease

The study hypothesis:

The null hypothesis: the combined incidence of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke in the treatment group is the same as that in control group.

The alternative hypothesis: the combined incidence of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke in the treatment group is different from that in control group.

Sample size:

2700 patients will be randomized, 1350 in treatment group and 1350 in placebo group.

Number of sites: 99 sites in China

Study drugs:

Heart-protecting Musk Pill and the matching placebo pills.

Design:

A randomized, double-blind, multi-centered, placebo-controlled trial. Patients will be randomized to treatment group and placebo group after screening and get corresponding treatment as follow.

Treatment group: Standard treatment for coronary artery disease plus 2 Heart-protecting Musk Pills each time, three times a day by mouth for 24 months.

Control group: Standard treatment for coronary artery disease plus 2 placebo pills each time, three times a day by mouth for 24 months.

Patients will be followed up at baseline, 1, 3, 6, 9, 12, 18, 24 months after randomization. During follow-up period, patients could undertake PCI or CABG if angina get out of control or evidence of ischemia aggravated is found.

연구 개요

상태

알려지지 않은

정황

개입 / 치료

연구 유형

중재적

등록 (예상)

2700

단계

  • 4단계

연락처 및 위치

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

연구 장소

  • 중국
    • Anhui
      • Hefei, Anhui, 중국, 230000
        • Anhui Provincial Hospital
      • Hefei, Anhui, 중국, 230000
        • The First Affiliated Hospital of Medical University Of Anhui
      • Maanshan, Anhui, 중국, 243000
        • MaAnShan Central Hospital
    • Beijing
      • Beijing, Beijing, 중국, 100000
        • Beijing An Zhen Hospital of the Capital University of Medical Sciences
      • Beijing, Beijing, 중국, 100000
        • Beijing Hospital
      • Beijing, Beijing, 중국, 100000
        • Beijing Shijitan Hospital
      • Beijing, Beijing, 중국, 100000
        • Beijing Tongren Hospital Capital Medical University
      • Beijing, Beijing, 중국, 100000
        • Dongfang Hospital Affiliated to Beijing University of Chinese Medicine
      • Beijing, Beijing, 중국, 100000
        • Navi General Hospital
      • Beijing, Beijing, 중국, 100000
        • Peking University First Hospital
    • Chongqing
      • Chongqing, Chongqing, 중국, 400000
        • Armed police Chongqing Corps Hospital
      • Chongqing, Chongqing, 중국, 400000
        • The Third People's Hospital of Chongqing
    • Fujian
      • Fuzhou, Fujian, 중국, 350000
        • Fujian Provincial Hospital
      • Fuzhou, Fujian, 중국, 350000
        • People's Hospital of Fujian Province
      • Putian, Fujian, 중국, 351100
        • The Affiliated Hospital of Putian University
      • Xiamen, Fujian, 중국, 361000
        • Xiamen Heart Center
    • Guangdong
      • Guangzhou, Guangdong, 중국, 510000
        • Affiliated Hospital of Guangzhou Medcal College
      • Guangzhou, Guangdong, 중국, 510000
        • The First Affiliated Hospital of Guangzhou University of Chinese Medicine
      • Guangzhou, Guangdong, 중국, 510000
        • The First Affiliated Hospital Sun Yat-Sen University
      • Jiangmen, Guangdong, 중국, 529000
        • The People's Hospital of Jiangmen
      • Shenzhen, Guangdong, 중국, 518000
        • Shenzhen People's Hospital
      • Zhanjiang, Guangdong, 중국, 524000
        • The Affiliated Hospital of Guangdong Medical College
    • Guangxi
      • Liuzhou, Guangxi, 중국, 545000
        • The First People's Hospital of Liuzhou City
      • Nanning, Guangxi, 중국, 530000
        • The First Affiliated Hospital of Guangxi University of Chinese Medicine
    • Hebei
      • Shijiazhuang, Hebei, 중국, 050000
        • HeBei General Hosital
      • Shijiazhuang, Hebei, 중국, 050000
        • The Seond Hospital of HeBei Medical University
      • Tangshan, Hebei, 중국, 063000
        • Tangshan Gongren Hospital
    • Heilongjiang
      • Daqing, Heilongjiang, 중국, 163000
        • DaQing General Hospial Group LongNan Hosptial
    • Henan
      • Kaifeng, Henan, 중국, 475000
        • Kaifeng Central Hospital
      • Zhengzhou, Henan, 중국, 450000
        • The First Affiliated Hospital of Zhengzhou University
      • Zhengzhou, Henan, 중국, 450000
        • People's Hospital of Henan Province
      • Zhengzhou, Henan, 중국, 450000
        • The first affiliated hospital of henan university of TCM
      • Zhengzhou, Henan, 중국, 450000
        • The Second Affiliated Hospital of Henan University of TCM
      • Zhengzhou, Henan, 중국, 450000
        • The Second Affiliated Hospital of Zhengzhou University
    • Hubei
      • Shiyan, Hubei, 중국, 442000
        • Taihe Hospital
      • Wuhan, Hubei, 중국, 430000
        • Renmin Hospital of Wuhan University
      • Wuhan, Hubei, 중국, 430000
        • Zhongnan Hospital of Wuhan University
      • Wuhan, Hubei, 중국, 430000
        • Hubei Provincial Corps Hospital of CPAPF
      • Xiangyang, Hubei, 중국, 441100
        • Xiangyang Central Hospital
    • Hunan
      • Changde, Hunan, 중국, 415000
        • The First People's Hospital of Changde
      • Changsha, Hunan, 중국, 410000
        • The Second Xiangya Hospital of Central South University
      • Changsha, Hunan, 중국, 410000
        • Xiangya Hospital Central-South University
      • Hengyang, Hunan, 중국, 421000
        • The First Affiliated Hospital of University of South China
    • Jiangsu
      • Nanjing, Jiangsu, 중국, 210000
        • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
      • Nanjing, Jiangsu, 중국, 210000
        • JiangSu Province Hosptial of TCM
      • Nanjing, Jiangsu, 중국, 210000
        • JiangSu Province Hosptial
      • Nanjing, Jiangsu, 중국, 210000
        • Nanjing First Hospital
      • Nanjing, Jiangsu, 중국, 210000
        • NanJing Hospital of TCM
      • Suzhou, Jiangsu, 중국, 215000
        • Suzhou Municipal Hospital
      • Taizhou, Jiangsu, 중국, 225300
        • Jiangsu Taizhou People's Hospital
      • Wuxi, Jiangsu, 중국, 214000
        • Wuxi People's Hospital
      • Xuzhou, Jiangsu, 중국, 221000
        • The Affiliated Hospital of Xuzhou Medical College
      • Yangzhou, Jiangsu, 중국, 225000
        • Northern Jiangsu People's Hospital
      • Yangzhou, Jiangsu, 중국, 225000
        • YangZhou No. 1 People's Hospital
    • Jiangxi
      • Nanchang, Jiangxi, 중국, 330000
        • The Second Affiliated Hospital of Nanchang University
      • Nanchang, Jiangxi, 중국, 330000
        • The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
      • Nanchang, Jiangxi, 중국, 330000
        • The First Hospital of Nanchang
    • Jilin
      • Changchun, Jilin, 중국, 160000
        • China-Japan Union Hospital of Jilin University
    • Liaoning
      • Anshan, Liaoning, 중국, 114000
        • The First Hospital of China Medical University
      • Dalian, Liaoning, 중국, 116000
        • The 210th Hospital of Chinese people's Liberation Army
      • Dalian, Liaoning, 중국, 116000
        • The second people's Hospital of Dalian
      • Shenyang, Liaoning, 중국, 110000
        • Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
      • Shenyang, Liaoning, 중국, 110000
        • The fourth Affiliated Hospital of China Medical University
    • Shandong
      • Jinan, Shandong, 중국, 250000
        • Affiliated Hospital of Shandong University of TCM
      • Jinan, Shandong, 중국, 250000
        • Shangdong Provincial Hospital
      • Linyi, Shandong, 중국, 276000
        • Linyi People's Hospital
      • Qinan, Shandong, 중국, 250000
        • QiLU Hospital of ShanDong University
      • Qingdao, Shandong, 중국, 264000
        • Qingdao University Medical College Affiliated Yuhuangding Hospital
      • Yantai, Shandong, 중국, 266000
        • The Affiliated Hospital of Medical College of Qingdao University
    • Shanghai
      • Shanghai, Shanghai, 중국, 200000
        • Huadong Hospital Affiliated to Fudan University
      • Shanghai, Shanghai, 중국, 200000
        • Huashan Hospital Fudan University
      • Shanghai, Shanghai, 중국, 200000
        • Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
      • Shanghai, Shanghai, 중국, 200000
        • Shanghai East Hospital
      • Shanghai, Shanghai, 중국, 200000
        • Shanghai First People's Hospital
      • Shanghai, Shanghai, 중국, 200000
        • ShuGuang Hospital
      • Shanghai, Shanghai, 중국, 200000
        • Tongji Hospital Affiliated to Tongji University
      • Shanghai, Shanghai, 중국, 200000
        • Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
      • Shanghai, Shanghai, 중국, 200000
        • Zhongshan Hospital Fudan University
    • Shanxi
      • Taiyuan, Shanxi, 중국, 030000
        • Shanxi Medical University First Hospital
      • Taiyuan, Shanxi, 중국, 030000
        • Shanxi Medical University Second Hospital
    • Sichuan
      • Chengdu, Sichuan, 중국, 610000
        • Sichuan Provincial People's Hospital
      • Luzhou, Sichuan, 중국, 646000
        • The Affiliated Hospital of Luzhou Medical College
      • Nanchong, Sichuan, 중국, 637000
        • Affiliated Hospital of Chuanbei Medical College
    • Tianjin
      • Tianjin, Tianjin, 중국, 300000
        • The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
      • Tianjin, Tianjin, 중국, 300000
        • TianHe Hospital
      • Tianjin, Tianjin, 중국, 300000
        • Tianjin Chest Hospital
      • Tianjin, Tianjin, 중국, 300000
        • Tianjin Third Central Hospital
    • Yunnan
      • Kunming, Yunnan, 중국, 650000
        • First People's Hospital of Yunnan Province
      • Kunming, Yunnan, 중국, 650000
        • Yunnan Provincial Hospital of Traditional Chinese Medicine
    • Zhejiang
      • Hangzhou, Zhejiang, 중국, 310000
        • The Affiliated Hospital of Hangzhou Normal University
      • Hangzhou, Zhejiang, 중국, 310000
        • Hangzhou Traditional Chinese Medical Hospital
      • Hangzhou, Zhejiang, 중국, 310000
        • The First Affiliated Hospital Zhejiang University
      • Hangzhou, Zhejiang, 중국, 310000
        • Tongde Hospital of Zhejiang Province
      • Hangzhou, Zhejiang, 중국, 310000
        • Zhejiang Hospital
      • Hangzhou, Zhejiang, 중국, 310000
        • Zhejiang Provincial Hospital of TCM
      • Ningbo, Zhejiang, 중국, 315000
        • Ningbo First Hospital
      • Ningbo, Zhejiang, 중국, 315000
        • Ningbo Medical Treatment Center of LiHuiLi Hospital
      • Wenzhou, Zhejiang, 중국, 325000
        • The Second Hospital Affiliated to Wenzhou Medical College

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

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  1. Age≥18 years at screening.
  2. Patients who have ischemia myocardial symptoms and whose clinical symptoms keep stable for at least one month.
  3. Have at least one of the following events (providing hospital records or inspection report): 1)history of acute myocardial infarction for at least half of a year; 2) history of PCI or CABG for at least half of a year; 3) coronary CT angiography or coronary angiography shows that at least one of the main branches of coronary artery stenosis is no less than 50%.
  4. Provide informed consent form.

Exclusion Criteria:

  1. History of acute myocardial infarction, vascular reconstruction, CABG or PCI within half of a year.
  2. Prepared to undertake CABG or PCI during this study.
  3. Serious cardiovascular diseases: sustained severe angina (CCS Ⅳ), refractory heart failure, cardiogenic shock, severe aortic stenosis or aortic insufficiency.
  4. Severe respiratory diseases;
  5. Diabetic patients with poor glycemic control (fasting blood glucose > 200 mg/dl or 11.1mmol/L for more than twice within one month before the study entry).
  6. Hypertensive patients with poor control of blood pressure, systolic pressure≥180mmHg or diastolic pressure≥110mmHg before entry.
  7. Severe liver and kidney diseases,such as active liver disease, cirrhosis and uremia.
  8. Any other severe diseases, such as malignant tumor, severe anemia and severe renal artery stenosis.
  9. Unable or unwilling to sign informed consent form.
  10. Join another trial or has received random allocation of this study within one month before entry.
  11. Pregnant or who were attempting to become pregnant.
  12. Patients who are regarded as not being suitable participants by the study investigators.

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: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Heart-protecting Musk Pill
Patients will get standard treatment for coronary artery disease plus 2 Heart-protecting Musk Pills each time, three times a day by mouth for 24 months
의약품: Heart-protecting Musk Pill
위약 비교기: Placebo
Patients will get standard treatment for coronary artery disease plus 2 placebo pills each time, three times a day by mouth for 24 months
의약품: 위약

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
기간
The combined incidence of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke
기간: 24 months
24 months

2차 결과 측정

결과 측정
기간
The combined incidence of all-cause mortality, nonfatal myocardial infarction, nonfatal stroke, hospitalization for unstable angina or heart failure, and peripheral revascularization (PCI or CABG)
기간: 24 months
24 months

기타 결과 측정

결과 측정
기간
The incidence of adverse event
기간: 24 months
24 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Shanghai Hutchison Pharmaceuticals Limited

수사관

  • 수석 연구원: Junbo Ge, Doctor, Fudan University

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

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

2011년 7월 1일

기본 완료 (예상)

2015년 6월 1일

연구 완료 (예상)

2015년 12월 1일

연구 등록 날짜

최초 제출

2013년 7월 9일

QC 기준을 충족하는 최초 제출

2013년 7월 9일

처음 게시됨 (추정)

2013년 7월 12일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2014년 12월 19일

QC 기준을 충족하는 마지막 업데이트 제출

2014년 12월 17일

마지막으로 확인됨

2014년 12월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • TG0930BXW

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. .

관상동맥 질환에 대한 임상 시험

위약에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Luxembourg

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다