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

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Drug: Placebo; Drug: Heart-protecting Musk Pill

• Study Type: Interventional
• Enrollment (Anticipated): 2700
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: Heart-protecting Musk Pill
Placebo Comparator: 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	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The combined incidence of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke	24 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
The incidence of adverse event	24 months

Collaborators and Investigators

• Sponsor: Shanghai Hutchison Pharmaceuticals Limited
• Investigators: Principal Investigator: Junbo Ge, Doctor, Fudan University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Anticipated): June 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: July 9, 2013
• First Submitted That Met QC Criteria: July 9, 2013
• First Posted (Estimate): July 12, 2013

Study Record Updates

• Last Update Posted (Estimate): December 19, 2014
• Last Update Submitted That Met QC Criteria: December 17, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Coronary artery disease
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: TG0930BXW