A Trial to Evaluate Efficacy of Heart-protecting Musk Pill

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01897805
• Other study ID #: TG0930BXW
• Status: Active, not recruiting
• Phase: Phase 4
• First received: July 9, 2013
• Last updated: December 17, 2014
• Start date: July 2011
• Est. completion date: December 2015

Study information

• Verified date: December 2014
• Source: Shanghai Hutchison Pharmaceuticals Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2700
• Est. completion date: December 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 ?), 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Heart-protecting Musk Pill

• Placebo

Locations

Country	Name	City	State
China	The First Hospital Of China Medical University	Anshan	Liaoning
China	Beijing An Zhen Hospital of the Capital University of Medical Sciences	Beijing	Beijing
China	Beijing Hospital	Beijing	Beijing
China	Beijing Shijitan Hospital	Beijing	Beijing
China	Beijing Tongren Hospital Capital Medical University	Beijing	Beijing
China	Dongfang Hospital Affiliated to Beijing University of Chinese Medicine	Beijing	Beijing
China	Navi General Hospital	Beijing	Beijing
China	Peking University First Hospital	Beijing	Beijing
China	China-Japan Union Hospital of Jilin University	Changchun	Jilin
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	Sichuan Provincial People's Hospital	Chengdu	Sichuan
China	Armed police Chongqing Corps Hospital	Chongqing	Chongqing
China	The Third People's Hospital of Chongqing	Chongqing	Chongqing
China	The 210th Hospital of Chinese people's Liberation Army	Dalian	Liaoning
China	The second people's Hospital of Dalian	Dalian	Liaoning
China	DaQing General Hospial Group LongNan Hosptial	Daqing	Heilongjiang
China	FuJian Provincial Hospital	Fuzhou	Fujian
China	People's Hospital of Fujian Province	Fuzhou	Fujian
China	Affiliated Hospital of Guangzhou Medcal College	Guangzhou	Guangdong
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	Hangzhou Traditional Chinese Medical Hospital	Hangzhou	Zhejiang
China	The Affiliated Hospital of Hangzhou Normal University	Hangzhou	Zhejiang
China	The First Affiliated Hospital ZheJiang University	Hangzhou	Zhejiang
China	Tongde Hospital of ZheJiang Province	Hangzhou	Zhejiang
China	ZheJiang Hospital	Hangzhou	Zhejiang
China	Zhejiang Provincial Hospital of TCM	Hangzhou	Zhejiang
China	AnHui Provincial Hospital	Hefei	Anhui
China	The First Affiliated Hospital of Medical University Of Anhui	Hefei	Anhui
China	The First Affiliated Hospital of University of South China	Hengyang	Hunan
China	The People's Hospital of Jiangmen	Jiangmen	Guangdong
China	Affiliated Hospital of Shandong University of TCM	Jinan	Shandong
China	Shangdong Provincial Hospital	Jinan	Shandong
China	KaiFeng Central Hospital	Kaifeng	Henan
China	First People's Hospital of Yunnan Province	Kunming	Yunnan
China	Yunnan Provincial Hospital of Traditional Chinese Medicine	Kunming	Yunnan
China	Linyi People's Hospital	Linyi	Shandong
China	The First People's Hospital of Liuzhou City	Liuzhou	Guangxi
China	The Affiliated Hospital of Luzhou Medical College	Luzhou	Sichuan
China	MaAnShan Central Hospital	Maanshan	Anhui
China	The Affiliated Hospital of JiangXi University of Traditional Chinese Medicine	Nanchang	Jiangxi
China	The First Hospital of NanChang	Nanchang	Jiangxi
China	The Second Affiliated Hospital of NanChang University	Nanchang	Jiangxi
China	Affiliated Hospital of Chuanbei Medical College	Nanchong	Sichuan
China	JiangSu Province Hosptial	Nanjing	Jiangsu
China	JiangSu Province Hosptial of TCM	Nanjing	Jiangsu
China	NanJing Drum Tower Hospital The Affiliated Hospital of NanJing University Medical School	Nanjing	Jiangsu
China	NanJing First Hospital	Nanjing	Jiangsu
China	NanJing Hospital of TCM	Nanjing	Jiangsu
China	The First Affiliated Hospital Of GuangXi University Of Chinese Medicine	Nanning	Guangxi
China	Ningbo First Hospital	Ningbo	Zhejiang
China	Ningbo Medical Treatment Center of LiHuiLi Hospital	Ningbo	Zhejiang
China	The Affiliated Hospital of PuTian University	Putian	Fujian
China	Qilu Hospital of Shandong University	Qinan	Shandong
China	Qingdao University Medical College Affiliated Yuhuangding Hospital	Qingdao	Shandong
China	Huadong Hospital Affiliated To Fudan University	Shanghai	Shanghai
China	Huashan Hospital Fudan University	Shanghai	Shanghai
China	Rui Jin Hospital Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai
China	Shanghai East Hospital	Shanghai	Shanghai
China	Shanghai First People's Hospital	Shanghai	Shanghai
China	Shuguang Hospital	Shanghai	Shanghai
China	Tongji Hospital Affiliated to Tongji University	Shanghai	Shanghai
China	Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai
China	Zhongshan hospital Fudan University	Shanghai	Shanghai
China	Affiliated Hospital of Liaoning University of Traditional Chinese Medicine	Shenyang	Liaoning
China	The Fourth Affiliated Hospital of China Medical University	Shenyang	Liaoning
China	ShenZhen People's Hospital	Shenzhen	Guangdong
China	HeBei General Hosital	Shijiazhuang	Hebei
China	The Seond Hospital of HeBei Medical University	Shijiazhuang	Hebei
China	Taihe Hospital	Shiyan	Hubei
China	SuZhou Municipal Hospital	Suzhou	Jiangsu
China	Shanxi Medical University First Hospital	Taiyuan	Shanxi
China	Shanxi Medical University Second Hospital	Taiyuan	Shanxi
China	JiangSu TaiZhou People's Hospital	Taizhou	Jiangsu
China	TangShan GongRen Hospital	Tangshan	Hebei
China	The First Teaching Hospital of TianJin University of Traditional Chinese Medicine	Tianjin	Tianjin
China	TianHe Hospital	Tianjin	Tianjin
China	TianJin Chest Hospital	Tianjin	Tianjin
China	Tianjin Third Central Hospital	Tianjin	Tianjin
China	The Second Hospital Affiliated to Wenzhou Medical College	Wenzhou	Zhejiang
China	Hubei Provincial Corps Hospital of CPAPF	Wuhan	Hubei
China	Renmin Hospital of Wuhan University	Wuhan	Hubei
China	Zhongnan Hospital of Wuhan University	Wuhan	Hubei
China	WuXi People's Hospital	Wuxi	Jiangsu
China	XiaMen Heart Center	Xiamen	Fujian
China	Xiangyang Central Hospital	Xiangyang	Hubei
China	The Affiliated Hospital of XuZhou Medical College	Xuzhou	Jiangsu
China	Northern JiangSu People's Hospital	Yangzhou	Jiangsu
China	YangZhou No. 1 People's Hospital	Yangzhou	Jiangsu
China	The Affiliated Hospital of Medical College of Qingdao University	Yantai	Shandong
China	The Affiliated Hospital of Guangdong Medical College	Zhanjiang	Guangdong
China	People's Hospital of Henan Province	Zhengzhou	Henan
China	The First Affiliated Hospital of Henan University of TCM	Zhengzhou	Henan
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan
China	The Second Affiliated Hospital of Henan University of TCM	Zhengzhou	Henan
China	The Second Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Hutchison Pharmaceuticals Limited

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The incidence of adverse event		24 months	Yes
Primary	The combined incidence of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke		24 months	No
Secondary	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	No