A Trial to Evaluate Efficacy of Heart-protecting Musk Pill
- Conditions
- Coronary Artery Disease
- Interventions
- Drug: PlaceboDrug: Heart-protecting Musk Pill
- Registration Number
- NCT01897805
- Lead Sponsor
- Shanghai Hutchison Pharmaceuticals Limited
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 2700
- Age≥18 years at screening.
- Patients who have ischemia myocardial symptoms and whose clinical symptoms keep stable for at least one month.
- 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%.
- Provide informed consent form.
- History of acute myocardial infarction, vascular reconstruction, CABG or PCI within half of a year.
- Prepared to undertake CABG or PCI during this study.
- Serious cardiovascular diseases: sustained severe angina (CCS Ⅳ), refractory heart failure, cardiogenic shock, severe aortic stenosis or aortic insufficiency.
- Severe respiratory diseases;
- 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).
- Hypertensive patients with poor control of blood pressure, systolic pressure≥180mmHg or diastolic pressure≥110mmHg before entry.
- Severe liver and kidney diseases,such as active liver disease, cirrhosis and uremia.
- Any other severe diseases, such as malignant tumor, severe anemia and severe renal artery stenosis.
- Unable or unwilling to sign informed consent form.
- Join another trial or has received random allocation of this study within one month before entry.
- Pregnant or who were attempting to become pregnant.
- Patients who are regarded as not being suitable participants by the study investigators.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo 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 Heart-protecting Musk Pill 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
- Primary Outcome Measures
Name Time Method The combined incidence of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke 24 months
- Secondary Outcome Measures
Name Time Method 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) 24 months
Trial Locations
- Locations (98)
ShenZhen People's Hospital
🇨🇳Shenzhen, Guangdong, China
The First People's Hospital of Liuzhou City
🇨🇳Liuzhou, Guangxi, China
The First Affiliated Hospital Of GuangXi University Of Chinese Medicine
🇨🇳Nanning, Guangxi, China
HeBei General Hosital
🇨🇳Shijiazhuang, Hebei, China
DaQing General Hospial Group LongNan Hosptial
🇨🇳Daqing, Heilongjiang, China
KaiFeng Central Hospital
🇨🇳Kaifeng, Henan, China
People's Hospital of Henan Province
🇨🇳Zhengzhou, Henan, China
SuZhou Municipal Hospital
🇨🇳Suzhou, Jiangsu, China
AnHui Provincial Hospital
🇨🇳Hefei, Anhui, China
The First Affiliated Hospital of Medical University Of Anhui
🇨🇳Hefei, Anhui, China
Beijing Tongren Hospital Capital Medical University
🇨🇳Beijing, Beijing, China
Navi General Hospital
🇨🇳Beijing, Beijing, China
Dongfang Hospital Affiliated to Beijing University of Chinese Medicine
🇨🇳Beijing, Beijing, China
The Seond Hospital of HeBei Medical University
🇨🇳Shijiazhuang, Hebei, China
The Second Affiliated Hospital of Henan University of TCM
🇨🇳Zhengzhou, Henan, China
Hubei Provincial Corps Hospital of CPAPF
🇨🇳Wuhan, Hubei, China
The First Affiliated Hospital of University of South China
🇨🇳Hengyang, Hunan, China
JiangSu Province Hosptial of TCM
🇨🇳Nanjing, Jiangsu, China
JiangSu TaiZhou People's Hospital
🇨🇳Taizhou, Jiangsu, China
JiangSu Province Hosptial
🇨🇳Nanjing, Jiangsu, China
NanJing Hospital of TCM
🇨🇳Nanjing, Jiangsu, China
The First Hospital of NanChang
🇨🇳Nanchang, Jiangxi, China
Northern JiangSu People's Hospital
🇨🇳Yangzhou, Jiangsu, China
China-Japan Union Hospital of Jilin University
🇨🇳Changchun, Jilin, China
The First Hospital Of China Medical University
🇨🇳Anshan, Liaoning, China
The 210th Hospital of Chinese people's Liberation Army
🇨🇳Dalian, Liaoning, China
The second people's Hospital of Dalian
🇨🇳Dalian, Liaoning, China
The Fourth Affiliated Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
Affiliated Hospital of Shandong University of TCM
🇨🇳Jinan, Shandong, China
Shangdong Provincial Hospital
🇨🇳Jinan, Shandong, China
Linyi People's Hospital
🇨🇳Linyi, Shandong, China
Qingdao University Medical College Affiliated Yuhuangding Hospital
🇨🇳Qingdao, Shandong, China
Qilu Hospital of Shandong University
🇨🇳Qinan, Shandong, China
Huadong Hospital Affiliated To Fudan University
🇨🇳Shanghai, Shanghai, China
Shanghai First People's Hospital
🇨🇳Shanghai, Shanghai, China
Shanghai East Hospital
🇨🇳Shanghai, Shanghai, China
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, Shanghai, China
Shuguang Hospital
🇨🇳Shanghai, Shanghai, China
Tongji Hospital Affiliated to Tongji University
🇨🇳Shanghai, Shanghai, China
Shanxi Medical University First Hospital
🇨🇳Taiyuan, Shanxi, China
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, Shanghai, China
Zhongshan hospital Fudan University
🇨🇳Shanghai, Shanghai, China
Shanxi Medical University Second Hospital
🇨🇳Taiyuan, Shanxi, China
Sichuan Provincial People's Hospital
🇨🇳Chengdu, Sichuan, China
TianJin Chest Hospital
🇨🇳Tianjin, Tianjin, China
The Affiliated Hospital of Luzhou Medical College
🇨🇳Luzhou, Sichuan, China
Yunnan Provincial Hospital of Traditional Chinese Medicine
🇨🇳Kunming, Yunnan, China
Tianjin Third Central Hospital
🇨🇳Tianjin, Tianjin, China
First People's Hospital of Yunnan Province
🇨🇳Kunming, Yunnan, China
The Affiliated Hospital of Hangzhou Normal University
🇨🇳Hangzhou, Zhejiang, China
The First Affiliated Hospital ZheJiang University
🇨🇳Hangzhou, Zhejiang, China
Hangzhou Traditional Chinese Medical Hospital
🇨🇳Hangzhou, Zhejiang, China
ZheJiang Hospital
🇨🇳Hangzhou, Zhejiang, China
Tongde Hospital of ZheJiang Province
🇨🇳Hangzhou, Zhejiang, China
Ningbo Medical Treatment Center of LiHuiLi Hospital
🇨🇳Ningbo, Zhejiang, China
Zhejiang Provincial Hospital of TCM
🇨🇳Hangzhou, Zhejiang, China
The Second Hospital Affiliated to Wenzhou Medical College
🇨🇳Wenzhou, Zhejiang, China
Armed police Chongqing Corps Hospital
🇨🇳Chongqing, Chongqing, China
Beijing Hospital
🇨🇳Beijing, Beijing, China
The Third People's Hospital of Chongqing
🇨🇳Chongqing, Chongqing, China
XiaMen Heart Center
🇨🇳Xiamen, Fujian, China
Beijing An Zhen Hospital of the Capital University of Medical Sciences
🇨🇳Beijing, Beijing, China
Beijing Shijitan Hospital
🇨🇳Beijing, Beijing, China
MaAnShan Central Hospital
🇨🇳Maanshan, Anhui, China
FuJian Provincial Hospital
🇨🇳Fuzhou, Fujian, China
The People's Hospital of Jiangmen
🇨🇳Jiangmen, Guangdong, China
Affiliated Hospital of Guangzhou Medcal College
🇨🇳Guangzhou, Guangdong, China
The Affiliated Hospital of PuTian University
🇨🇳Putian, Fujian, China
The Affiliated Hospital of Guangdong Medical College
🇨🇳Zhanjiang, Guangdong, China
TangShan GongRen Hospital
🇨🇳Tangshan, Hebei, China
The Second Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
People's Hospital of Fujian Province
🇨🇳Fuzhou, Fujian, China
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
🇨🇳Guangzhou, Guangdong, China
The First Affiliated Hospital Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
The First Affiliated Hospital of Henan University of TCM
🇨🇳Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
Taihe Hospital
🇨🇳Shiyan, Hubei, China
Xiangyang Central Hospital
🇨🇳Xiangyang, Hubei, China
The First People's Hospital of Changde
🇨🇳Changde, Hunan, China
The Second Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
Xiangya Hospital Central-South University
🇨🇳Changsha, Hunan, China
Renmin Hospital of Wuhan University
🇨🇳Wuhan, Hubei, China
Zhongnan Hospital of Wuhan University
🇨🇳Wuhan, Hubei, China
NanJing Drum Tower Hospital The Affiliated Hospital of NanJing University Medical School
🇨🇳Nanjing, Jiangsu, China
WuXi People's Hospital
🇨🇳Wuxi, Jiangsu, China
The Affiliated Hospital of XuZhou Medical College
🇨🇳Xuzhou, Jiangsu, China
YangZhou No. 1 People's Hospital
🇨🇳Yangzhou, Jiangsu, China
The Affiliated Hospital of JiangXi University of Traditional Chinese Medicine
🇨🇳Nanchang, Jiangxi, China
The Second Affiliated Hospital of NanChang University
🇨🇳Nanchang, Jiangxi, China
The Affiliated Hospital of Medical College of Qingdao University
🇨🇳Yantai, Shandong, China
Huashan Hospital Fudan University
🇨🇳Shanghai, Shanghai, China
Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
🇨🇳Shenyang, Liaoning, China
Affiliated Hospital of Chuanbei Medical College
🇨🇳Nanchong, Sichuan, China
TianHe Hospital
🇨🇳Tianjin, Tianjin, China
The First Teaching Hospital of TianJin University of Traditional Chinese Medicine
🇨🇳Tianjin, Tianjin, China
Ningbo First Hospital
🇨🇳Ningbo, Zhejiang, China
NanJing First Hospital
🇨🇳Nanjing, Jiangsu, China
Peking University First Hospital
🇨🇳Beijing, Beijing, China