A Trial to Evaluate Efficacy of Heart-protecting Musk Pill
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
1 other identifier
interventional
2,700
1 country
98
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 coronary-artery-disease
Started Jul 2011
Longer than P75 for phase_4 coronary-artery-disease
98 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 9, 2013
CompletedFirst Posted
Study publicly available on registry
July 12, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedDecember 19, 2014
December 1, 2014
3.9 years
July 9, 2013
December 17, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The combined incidence of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke
24 months
Secondary Outcomes (1)
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
Other Outcomes (1)
The incidence of adverse event
24 months
Study Arms (2)
Heart-protecting Musk Pill
EXPERIMENTALPatients 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
Placebo
PLACEBO COMPARATORPatients will get standard treatment for coronary artery disease plus 2 placebo pills each time, three times a day by mouth for 24 months
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (98)
AnHui Provincial Hospital
Hefei, Anhui, 230000, China
The First Affiliated Hospital of Medical University Of Anhui
Hefei, Anhui, 230000, China
MaAnShan Central Hospital
Maanshan, Anhui, 243000, China
Beijing An Zhen Hospital of the Capital University of Medical Sciences
Beijing, Beijing Municipality, 100000, China
Beijing Hospital
Beijing, Beijing Municipality, 100000, China
Beijing Shijitan Hospital
Beijing, Beijing Municipality, 100000, China
Beijing Tongren Hospital Capital Medical University
Beijing, Beijing Municipality, 100000, China
Dongfang Hospital Affiliated to Beijing University of Chinese Medicine
Beijing, Beijing Municipality, 100000, China
Navi General Hospital
Beijing, Beijing Municipality, 100000, China
Peking University First Hospital
Beijing, Beijing Municipality, 100000, China
Armed police Chongqing Corps Hospital
Chongqing, Chongqing Municipality, 400000, China
The Third People's Hospital of Chongqing
Chongqing, Chongqing Municipality, 400000, China
FuJian Provincial Hospital
Fuzhou, Fujian, 350000, China
People's Hospital of Fujian Province
Fuzhou, Fujian, 350000, China
The Affiliated Hospital of PuTian University
Putian, Fujian, 351100, China
XiaMen Heart Center
Xiamen, Fujian, 361000, China
Affiliated Hospital of Guangzhou Medcal College
Guangzhou, Guangdong, 510000, China
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, 510000, China
The First Affiliated Hospital Sun Yat-sen University
Guangzhou, Guangdong, 510000, China
The People's Hospital of Jiangmen
Jiangmen, Guangdong, 529000, China
ShenZhen People's Hospital
Shenzhen, Guangdong, 518000, China
The Affiliated Hospital of Guangdong Medical College
Zhanjiang, Guangdong, 524000, China
The First People's Hospital of Liuzhou City
Liuchow, Guangxi, 545000, China
The First Affiliated Hospital Of GuangXi University Of Chinese Medicine
Nanning, Guangxi, 530000, China
HeBei General Hosital
Shijiazhuang, Hebei, 050000, China
The Seond Hospital of HeBei Medical University
Shijiazhuang, Hebei, 050000, China
TangShan GongRen Hospital
Tangshan, Hebei, 063000, China
DaQing General Hospial Group LongNan Hosptial
Daqing, Heilongjiang, 163000, China
KaiFeng Central Hospital
Kaifeng, Henan, 475000, China
People's Hospital of Henan Province
Zhengzhou, Henan, 450000, China
The First Affiliated Hospital of Henan University of TCM
Zhengzhou, Henan, 450000, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000, China
The Second Affiliated Hospital of Henan University of TCM
Zhengzhou, Henan, 450000, China
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000, China
Taihe Hospital
Shiyan, Hubei, 442000, China
Hubei Provincial Corps Hospital of CPAPF
Wuhan, Hubei, 430000, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430000, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430000, China
Xiangyang Central Hospital
Xiangyang, Hubei, 441100, China
The First People's Hospital of Changde
Changde, Hunan, 415000, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410000, China
Xiangya Hospital Central-South University
Changsha, Hunan, 410000, China
The First Affiliated Hospital of University of South China
Hengyang, Hunan, 421000, China
JiangSu Province Hosptial of TCM
Nanjing, Jiangsu, 210000, China
JiangSu Province Hosptial
Nanjing, Jiangsu, 210000, China
NanJing Drum Tower Hospital The Affiliated Hospital of NanJing University Medical School
Nanjing, Jiangsu, 210000, China
NanJing First Hospital
Nanjing, Jiangsu, 210000, China
NanJing Hospital of TCM
Nanjing, Jiangsu, 210000, China
SuZhou Municipal Hospital
Suzhou, Jiangsu, 215000, China
JiangSu TaiZhou People's Hospital
Taizhou, Jiangsu, 225300, China
WuXi People's Hospital
Wuxi, Jiangsu, 214000, China
The Affiliated Hospital of XuZhou Medical College
Xuzhou, Jiangsu, 221000, China
Northern JiangSu People's Hospital
Yangzhou, Jiangsu, 225000, China
YangZhou No. 1 People's Hospital
Yangzhou, Jiangsu, 225000, China
The Affiliated Hospital of JiangXi University of Traditional Chinese Medicine
Nanchang, Jiangxi, 330000, China
The First Hospital of NanChang
Nanchang, Jiangxi, 330000, China
The Second Affiliated Hospital of NanChang University
Nanchang, Jiangxi, 330000, China
China-Japan Union Hospital of Jilin University
Changchun, Jilin, 160000, China
The First Hospital Of China Medical University
Anshan, Liaoning, 114000, China
The 210th Hospital of Chinese people's Liberation Army
Dalian, Liaoning, 116000, China
The second people's Hospital of Dalian
Dalian, Liaoning, 116000, China
Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
Shenyang, Liaoning, 110000, China
The Fourth Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110000, China
Affiliated Hospital of Shandong University of TCM
Jinan, Shandong, 250000, China
Shangdong Provincial Hospital
Jinan, Shandong, 250000, China
Linyi People's Hospital
Linyi, Shandong, 276000, China
Qilu Hospital of Shandong University
Qinan, Shandong, 250000, China
Qingdao University Medical College Affiliated Yuhuangding Hospital
Qingdao, Shandong, 264000, China
The Affiliated Hospital of Medical College of Qingdao University
Yantai, Shandong, 266000, China
Huadong Hospital Affiliated To Fudan University
Shanghai, Shanghai Municipality, 200000, China
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, 200000, China
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200000, China
Shanghai East Hospital
Shanghai, Shanghai Municipality, 200000, China
Shanghai First People's Hospital
Shanghai, Shanghai Municipality, 200000, China
Shuguang Hospital
Shanghai, Shanghai Municipality, 200000, China
Tongji Hospital Affiliated to Tongji University
Shanghai, Shanghai Municipality, 200000, China
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200000, China
Zhongshan hospital Fudan University
Shanghai, Shanghai Municipality, 200000, China
Shanxi Medical University First Hospital
Taiyuan, Shanxi, 030000, China
Shanxi Medical University Second Hospital
Taiyuan, Shanxi, 030000, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610000, China
The Affiliated Hospital of Luzhou Medical College
Luzhou, Sichuan, 646000, China
Affiliated Hospital of Chuanbei Medical College
Nanchong, Sichuan, 637000, China
The First Teaching Hospital of TianJin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality, 300000, China
TianHe Hospital
Tianjin, Tianjin Municipality, 300000, China
TianJin Chest Hospital
Tianjin, Tianjin Municipality, 300000, China
Tianjin Third Central Hospital
Tianjin, Tianjin Municipality, 300000, China
First People's Hospital of Yunnan Province
Kunming, Yunnan, 650000, China
Yunnan Provincial Hospital of Traditional Chinese Medicine
Kunming, Yunnan, 650000, China
Hangzhou Traditional Chinese Medical Hospital
Hangzhou, Zhejiang, 310000, China
The Affiliated Hospital of Hangzhou Normal University
Hangzhou, Zhejiang, 310000, China
The First Affiliated Hospital ZheJiang University
Hangzhou, Zhejiang, 310000, China
Tongde Hospital of ZheJiang Province
Hangzhou, Zhejiang, 310000, China
ZheJiang Hospital
Hangzhou, Zhejiang, 310000, China
Zhejiang Provincial Hospital of TCM
Hangzhou, Zhejiang, 310000, China
Ningbo First Hospital
Ningbo, Zhejiang, 315000, China
Ningbo Medical Treatment Center of LiHuiLi Hospital
Ningbo, Zhejiang, 315000, China
The Second Hospital Affiliated to Wenzhou Medical College
Wenzhou, Zhejiang, 325000, China
Related Publications (1)
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.
PMID: 36386372DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Junbo Ge, Doctor
Fudan University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 9, 2013
First Posted
July 12, 2013
Study Start
July 1, 2011
Primary Completion
June 1, 2015
Study Completion
December 1, 2015
Last Updated
December 19, 2014
Record last verified: 2014-12