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A Trial to Evaluate Efficacy of Heart-protecting Musk Pill

2014年12月17日 更新者：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.

研究概览

地位

未知

条件

干预/治疗

研究类型

介入性

注册 (预期的)

2700

阶段

  • 第四阶段

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

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

18年 至 85年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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.

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：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：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
药品：Heart-protecting Musk Pill
安慰剂比较：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
药品：安慰剂

研究衡量的是什么？

主要结果指标

结果测量
大体时间
The combined incidence of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke
大体时间：24 months
24 months

次要结果测量

结果测量
大体时间
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)
大体时间：24 months
24 months

其他结果措施

结果测量
大体时间
The incidence of adverse event
大体时间：24 months
24 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

Shanghai Hutchison Pharmaceuticals Limited

调查人员

  • 首席研究员：Junbo Ge, Doctor、Fudan University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

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

2011年7月1日

初级完成 (预期的)

2015年6月1日

研究完成 (预期的)

2015年12月1日

研究注册日期

首次提交

2013年7月9日

首先提交符合 QC 标准的

2013年7月9日

首次发布 (估计)

2013年7月12日

研究记录更新

最后更新发布 (估计)

2014年12月19日

上次提交的符合 QC 标准的更新

2014年12月17日

最后验证

2014年12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

  • TG0930BXW

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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