A Trial to Evaluate Efficacy of Heart-protecting Musk Pill

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Shanghai Hutchison Pharmaceuticals Limited
ClinicalTrials.gov Identifier:
NCT01897805
First received: July 9, 2013
Last updated: July 12, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Drug: Heart-protecting Musk Pill
Drug: Placebo
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Shanghai Hutchison Pharmaceuticals Limited:

Primary Outcome Measures:
  • The combined incidence of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • The incidence of adverse event [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 2700
Study Start Date: July 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01897805

  Hide Study Locations
Locations
China, Anhui
AnHui Provincial Hospital
Hefei, Anhui, China, 230000
The First Affiliated Hospital of Medical University Of Anhui
Hefei, Anhui, China, 230000
MaAnShan Central Hospital
Maanshan, Anhui, China, 243000
China, Beijing
Beijing Hospital
Beijing, Beijing, China, 100000
Dongfang Hospital Affiliated to Beijing University of Chinese Medicine
Beijing, Beijing, China, 100000
Peking University First Hospital
Beijing, Beijing, China, 100000
Beijing An Zhen Hospital of the Capital University of Medical Sciences
Beijing, Beijing, China, 100000
Beijing Tongren Hospital Capital Medical University
Beijing, Beijing, China, 100000
Navi General Hospital
Beijing, Beijing, China, 100000
Beijing Shijitan Hospital
Beijing, Beijing, China, 100000
China, Chongqing
Armed police Chongqing Corps Hospital
Chongqing, Chongqing, China, 400000
The Third People's Hospital of Chongqing
Chongqing, Chongqing, China, 400000
China, Fujian
FuJian Provincial Hospital
Fuzhou, Fujian, China, 350000
People's Hospital of Fujian Province
Fuzhou, Fujian, China, 350000
The Affiliated Hospital of PuTian University
Putian, Fujian, China, 351100
XiaMen Heart Center
Xiamen, Fujian, China, 361000
China, Guangdong
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, China, 510000
The First Affiliated Hospital Sun Yat-sen University
Guangzhou, Guangdong, China, 510000
Affiliated Hospital of Guangzhou Medcal College
Guangzhou, Guangdong, China, 510000
The People's Hospital of Jiangmen
Jiangmen, Guangdong, China, 529000
ShenZhen People's Hospital
Shenzhen, Guangdong, China, 518000
The Affiliated Hospital of Guangdong Medical College
Zhanjiang, Guangdong, China, 524000
China, Guangxi
The First People's Hospital of Liuzhou City
Liuzhou, Guangxi, China, 545000
The First Affiliated Hospital Of GuangXi University Of Chinese Medicine
Nanning, Guangxi, China, 530000
China, Hebei
The Seond Hospital of HeBei Medical University
Shijiazhuang, Hebei, China, 050000
HeBei General Hosital
Shijiazhuang, Hebei, China, 050000
TangShan GongRen Hospital
Tangshan, Hebei, China, 063000
China, Heilongjiang
DaQing General Hospial Group LongNan Hosptial
Daqing, Heilongjiang, China, 163000
China, Henan
KaiFeng Central Hospital
Kaifeng, Henan, China, 475000
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 First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450000
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450000
China, Hubei
Taihe Hospital
Shiyan, Hubei, China, 442000
Hubei Provincial Corps Hospital of CPAPF
Wuhan, Hubei, China, 430000
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China, 430000
Renmin Hospital of Wuhan University
Wuhan, Hubei, China, 430000
Xiangyang Central Hospital
Xiangyang, Hubei, China, 441100
China, Hunan
The First People's Hospital of Changde
Changde, Hunan, China, 415000
Xiangya Hospital Central-South University
Changsha, Hunan, China, 410000
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China, 410000
The First Affiliated Hospital of University of South China
Hengyang, Hunan, China, 421000
China, Jiangsu
JiangSu Province Hosptial
Nanjing, Jiangsu, China, 210000
JiangSu Province Hosptial of TCM
Nanjing, Jiangsu, China, 210000
NanJing Drum Tower Hospital The Affiliated Hospital of NanJing University Medical School
Nanjing, Jiangsu, China, 210000
NanJing Hospital of TCM
Nanjing, Jiangsu, China, 210000
NanJing First Hospital
Nanjing, Jiangsu, China, 210000
SuZhou Municipal Hospital
Suzhou, Jiangsu, China, 215000
JiangSu TaiZhou People's Hospital
Taizhou, Jiangsu, China, 225300
WuXi People's Hospital
Wuxi, Jiangsu, China, 214000
The Affiliated Hospital of XuZhou Medical College
Xuzhou, Jiangsu, China, 221000
YangZhou No. 1 People's Hospital
Yangzhou, Jiangsu, China, 225000
Northern JiangSu People's Hospital
Yangzhou, Jiangsu, China, 225000
China, Jiangxi
The Affiliated Hospital of JiangXi University of Traditional Chinese Medicine
Nanchang, Jiangxi, China, 330000
The First Hospital of NanChang
Nanchang, Jiangxi, China, 330000
The Second Affiliated Hospital of NanChang University
Nanchang, Jiangxi, China, 330000
China, Jilin
China-Japan Union Hospital of Jilin University
Changchun, Jilin, China, 160000
China, Liaoning
The First Hospital Of China Medical University
Anshan, Liaoning, China, 114000
The second people's Hospital of Dalian
Dalian, Liaoning, China, 116000
The 210th Hospital of Chinese people's Liberation Army
Dalian, Liaoning, China, 116000
The Fourth Affiliated Hospital of China Medical University
Shenyang, Liaoning, China, 110000
Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
Shenyang, Liaoning, China, 110000
China, Shandong
Shangdong Provincial Hospital
Jinan, Shandong, China, 250000
Affiliated Hospital of Shandong University of TCM
Jinan, Shandong, China, 250000
Linyi People's Hospital
Linyi, Shandong, China, 276000
Qilu Hospital of Shandong University
Qinan, Shandong, China, 250000
Qingdao University Medical College Affiliated Yuhuangding Hospital
Qingdao, Shandong, China, 264000
The Affiliated Hospital of Medical College of Qingdao University
Yantai, Shandong, China, 266000
China, Shanghai
Zhongshan hospital Fudan University
Shanghai, Shanghai, China, 200000
Huashan Hospital Fudan University
Shanghai, Shanghai, China, 200000
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai, China, 200000
Shuguang Hospital
Shanghai, Shanghai, China, 200000
Shanghai First People's Hospital
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
Tongji Hospital Affiliated to Tongji University
Shanghai, Shanghai, China, 200000
Huadong Hospital Affiliated To Fudan University
Shanghai, Shanghai, China, 200000
China, Shanxi
Shanxi Medical University First Hospital
Taiyuan, Shanxi, China, 030000
Shanxi Medical University Second Hospital
Taiyuan, Shanxi, China, 030000
China, Sichuan
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China, 610000
The Affiliated Hospital of Luzhou Medical College
Luzhou, Sichuan, China, 646000
Affiliated Hospital of Chuanbei Medical College
Nanchong, Sichuan, China, 637000
China, Tianjin
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
Tianjin, Tianjin, China, 300000
China, Yunnan
Yunnan Provincial Hospital of Traditional Chinese Medicine
Kunming, Yunnan, China, 650000
First People's Hospital of Yunnan Province
Kunming, Yunnan, China, 650000
China, Zhejiang
Tongde Hospital of ZheJiang Province
Hangzhou, Zhejiang, China, 310000
ZheJiang Hospital
Hangzhou, Zhejiang, China, 310000
The First Affiliated Hospital ZheJiang University
Hangzhou, Zhejiang, China, 310000
Zhejiang Provincial Hospital of TCM
Hangzhou, Zhejiang, China, 310000
Hangzhou Traditional Chinese Medical Hospital
Hangzhou, Zhejiang, China, 310000
The Affiliated Hospital of Hangzhou Normal University
Hangzhou, Zhejiang, China, 310000
Ningbo First Hospital
Ningbo, Zhejiang, China, 315000
Ningbo Medical Treatment Center of LiHuiLi Hospital
Ningbo, Zhejiang, China, 315000
The Second Hospital Affiliated to Wenzhou Medical College
Wenzhou, Zhejiang, China, 325000
Sponsors and Collaborators
Shanghai Hutchison Pharmaceuticals Limited
Investigators
Principal Investigator: Junbo Ge, Doctor Fudan University
  More Information

No publications provided

Responsible Party: Shanghai Hutchison Pharmaceuticals Limited
ClinicalTrials.gov Identifier: NCT01897805     History of Changes
Other Study ID Numbers: TG0930BXW
Study First Received: July 9, 2013
Last Updated: July 12, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Shanghai Hutchison Pharmaceuticals Limited:
Coronary artery disease

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014