Clinical trial NCT01897805: A Trial to Evaluate Efficacy of Heart-protecting Musk Pill
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: Coronary artery disease
Lead sponsor: Shanghai Hutchison Pharmaceuticals Limited
Sponsor class: INDUSTRY
First posted: 2013-07-12
Enrollment: 2700
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The combined incidence of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke
timeFrame: 24 months
Secondary outcomes:
measure: 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)
timeFrame: 24 months
Other outcomes:
measure: The incidence of adverse event
timeFrame: 24 months
Locations:
city: Hefei
country: China
facility: AnHui Provincial Hospital
state: Anhui
city: Hefei
country: China
facility: The First Affiliated Hospital of Medical University Of Anhui
state: Anhui
city: Maanshan
country: China
facility: MaAnShan Central Hospital
state: Anhui
city: Beijing
country: China
facility: Beijing An Zhen Hospital of the Capital University of Medical Sciences
state: Beijing
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Shijitan Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Tongren Hospital Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Dongfang Hospital Affiliated to Beijing University of Chinese Medicine
state: Beijing
city: Beijing
country: China
facility: Navi General Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Chongqing
country: China
facility: Armed police Chongqing Corps Hospital
state: Chongqing
city: Chongqing
country: China
facility: The Third People's Hospital of Chongqing
state: Chongqing
city: Fuzhou
country: China
facility: FuJian Provincial Hospital
state: Fujian
city: Fuzhou
country: China
facility: People's Hospital of Fujian Province
state: Fujian
city: Putian
country: China
facility: The Affiliated Hospital of PuTian University
state: Fujian
city: Xiamen
country: China
facility: XiaMen Heart Center
state: Fujian
city: Guangzhou
country: China
facility: Affiliated Hospital of Guangzhou Medcal College
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou University of Chinese Medicine
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital Sun Yat-sen University
state: Guangdong
city: Jiangmen
country: China
facility: The People's Hospital of Jiangmen
state: Guangdong
city: Shenzhen
country: China
facility: ShenZhen People's Hospital
state: Guangdong
city: Zhanjiang
country: China
facility: The Affiliated Hospital of Guangdong Medical College
state: Guangdong
city: Liuzhou
country: China
facility: The First People's Hospital of Liuzhou City
state: Guangxi
city: Nanning
country: China
facility: The First Affiliated Hospital Of GuangXi University Of Chinese Medicine
state: Guangxi
city: Shijiazhuang
country: China
facility: HeBei General Hosital
state: Hebei
city: Shijiazhuang
country: China
facility: The Seond Hospital of HeBei Medical University
state: Hebei
city: Tangshan
country: China
facility: TangShan GongRen Hospital
state: Hebei
city: Daqing
country: China
facility: DaQing General Hospial Group LongNan Hosptial
state: Heilongjiang
city: Kaifeng
country: China
facility: KaiFeng Central Hospital
state: Henan
city: Zhengzhou
country: China
facility: People's Hospital of Henan Province
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Henan University of TCM
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Zhengzhou
country: China
facility: The Second Affiliated Hospital of Henan University of TCM
state: Henan
city: Zhengzhou
country: China
facility: The Second Affiliated Hospital of Zhengzhou University
state: Henan
city: Shiyan
country: China
facility: Taihe Hospital
state: Hubei
city: Wuhan
country: China
facility: Hubei Provincial Corps Hospital of CPAPF
state: Hubei
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
state: Hubei
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hubei
city: Xiangyang
country: China
facility: Xiangyang Central Hospital
state: Hubei
city: Changde
country: China
facility: The First People's Hospital of Changde
state: Hunan
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Changsha
country: China
facility: Xiangya Hospital Central-South University
state: Hunan
city: Hengyang
country: China
facility: The First Affiliated Hospital of University of South China
state: Hunan
city: Nanjing
country: China
facility: JiangSu Province Hosptial of TCM
state: Jiangsu
city: Nanjing
country: China
facility: JiangSu Province Hosptial
state: Jiangsu
city: Nanjing
country: China
facility: NanJing Drum Tower Hospital The Affiliated Hospital of NanJing University Medical School
state: Jiangsu
city: Nanjing
country: China
facility: NanJing First Hospital
state: Jiangsu
city: Nanjing
country: China
facility: NanJing Hospital of TCM
state: Jiangsu
city: Suzhou
country: China
facility: SuZhou Municipal Hospital
state: Jiangsu
city: Taizhou
country: China
facility: JiangSu TaiZhou People's Hospital
state: Jiangsu
city: Wuxi
country: China
facility: WuXi People's Hospital
state: Jiangsu
city: Xuzhou
country: China
facility: The Affiliated Hospital of XuZhou Medical College
state: Jiangsu
city: Yangzhou
country: China
facility: Northern JiangSu People's Hospital
state: Jiangsu
city: Yangzhou
country: China
facility: YangZhou No. 1 People's Hospital
state: Jiangsu
city: Nanchang
country: China
facility: The Affiliated Hospital of JiangXi University of Traditional Chinese Medicine
state: Jiangxi
city: Nanchang
country: China
facility: The First Hospital of NanChang
state: Jiangxi
city: Nanchang
country: China
facility: The Second Affiliated Hospital of NanChang University
state: Jiangxi
city: Changchun
country: China
facility: China-Japan Union Hospital of Jilin University
state: Jilin
city: Anshan
country: China
facility: The First Hospital Of China Medical University
state: Liaoning
city: Dalian
country: China
facility: The 210th Hospital of Chinese people's Liberation Army
state: Liaoning
city: Dalian
country: China
facility: The second people's Hospital of Dalian
state: Liaoning
city: Shenyang
country: China
facility: Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
state: Liaoning
city: Shenyang
country: China
facility: The Fourth Affiliated Hospital of China Medical University
state: Liaoning
city: Jinan
country: China
facility: Affiliated Hospital of Shandong University of TCM
state: Shandong
city: Jinan
country: China
facility: Shangdong Provincial Hospital
state: Shandong
city: Linyi
country: China
facility: Linyi People's Hospital
state: Shandong
city: Qinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Qingdao
country: China
facility: Qingdao University Medical College Affiliated Yuhuangding Hospital
state: Shandong
city: Yantai
country: China
facility: The Affiliated Hospital of Medical College of Qingdao University
state: Shandong
city: Shanghai
country: China
facility: Huadong Hospital Affiliated To Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Huashan Hospital Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Shanghai East Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai First People's Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shuguang Hospital
state: Shanghai
city: Shanghai
country: China
facility: Tongji Hospital Affiliated to Tongji University
state: Shanghai
city: Shanghai
country: China
facility: Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Zhongshan hospital Fudan University
state: Shanghai
city: Taiyuan
country: China
facility: Shanxi Medical University First Hospital
state: Shanxi
city: Taiyuan
country: China
facility: Shanxi Medical University Second Hospital
state: Shanxi
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
state: Sichuan
city: Luzhou
country: China
facility: The Affiliated Hospital of Luzhou Medical College
state: Sichuan
city: Nanchong
country: China
facility: Affiliated Hospital of Chuanbei Medical College
state: Sichuan
city: Tianjin
country: China
facility: The First Teaching Hospital of TianJin University of Traditional Chinese Medicine
state: Tianjin
city: Tianjin
country: China
facility: TianHe Hospital
state: Tianjin
city: Tianjin
country: China
facility: TianJin Chest Hospital
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Third Central Hospital
state: Tianjin
city: Kunming
country: China
facility: First People's Hospital of Yunnan Province
state: Yunnan
city: Kunming
country: China
facility: Yunnan Provincial Hospital of Traditional Chinese Medicine
state: Yunnan
city: Hangzhou
country: China
facility: Hangzhou Traditional Chinese Medical Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: The Affiliated Hospital of Hangzhou Normal University
state: Zhejiang
city: Hangzhou
country: China
facility: The First Affiliated Hospital ZheJiang University
state: Zhejiang
city: Hangzhou
country: China
facility: Tongde Hospital of ZheJiang Province
state: Zhejiang
city: Hangzhou
country: China
facility: ZheJiang Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Provincial Hospital of TCM
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo First Hospital
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo Medical Treatment Center of LiHuiLi Hospital
state: Zhejiang
city: Wenzhou
country: China
facility: The Second Hospital Affiliated to Wenzhou Medical College
state: Zhejiang
Study officials:
affiliation: Fudan University
name: Junbo Ge, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shi H, Zhou J, Ma C, Ji F, Wu Y, Zhao Y, Qian J, Wang X. Shexiang Baoxin Pill (MUSKARDIA) reduces major adverse cardiovascular events in women with stable coronary artery disease: A subgroup analysis of a phase IV randomized clinical trial. Front Cardiovasc Med. 2022 Oct 21;9:1002400. doi: 10.3389/fcvm.2022.1002400. eCollection 2022.