A Trial to Evaluate Efficacy of Heart-protecting Musk Pill
17 de diciembre de 2014 actualizado por: Shanghai Hutchison Pharmaceuticals Limited
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.
Descripción general del estudio
Estado
Desconocido
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
2700
Fase
- Fase 4
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Anhui
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Hefei, Anhui, Porcelana, 230000
- Anhui Provincial Hospital
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Hefei, Anhui, Porcelana, 230000
- The First Affiliated Hospital of Medical University Of Anhui
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Maanshan, Anhui, Porcelana, 243000
- MaAnShan Central Hospital
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Beijing
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Beijing, Beijing, Porcelana, 100000
- Beijing An Zhen Hospital of the Capital University of Medical Sciences
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Beijing, Beijing, Porcelana, 100000
- Beijing Hospital
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Beijing, Beijing, Porcelana, 100000
- Beijing Shijitan Hospital
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Beijing, Beijing, Porcelana, 100000
- Beijing Tongren Hospital Capital Medical University
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Beijing, Beijing, Porcelana, 100000
- Dongfang Hospital Affiliated to Beijing University of Chinese Medicine
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Beijing, Beijing, Porcelana, 100000
- Navi General Hospital
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Beijing, Beijing, Porcelana, 100000
- Peking University first hospital
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Chongqing
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Chongqing, Chongqing, Porcelana, 400000
- Armed police Chongqing Corps Hospital
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Chongqing, Chongqing, Porcelana, 400000
- The Third People's Hospital of Chongqing
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Fujian
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Fuzhou, Fujian, Porcelana, 350000
- Fujian Provincial Hospital
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Fuzhou, Fujian, Porcelana, 350000
- People's Hospital of Fujian Province
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Putian, Fujian, Porcelana, 351100
- The Affiliated Hospital of Putian University
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Xiamen, Fujian, Porcelana, 361000
- Xiamen Heart Center
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Guangdong
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Guangzhou, Guangdong, Porcelana, 510000
- Affiliated Hospital of Guangzhou Medcal College
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Guangzhou, Guangdong, Porcelana, 510000
- The First Affiliated Hospital of Guangzhou University of Chinese Medicine
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Guangzhou, Guangdong, Porcelana, 510000
- The First Affiliated Hospital Sun Yat-Sen University
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Jiangmen, Guangdong, Porcelana, 529000
- The People's Hospital of Jiangmen
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Shenzhen, Guangdong, Porcelana, 518000
- ShenZhen People's Hospital
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Zhanjiang, Guangdong, Porcelana, 524000
- The Affiliated Hospital of Guangdong Medical College
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Guangxi
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Liuzhou, Guangxi, Porcelana, 545000
- The First People's Hospital of Liuzhou City
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Nanning, Guangxi, Porcelana, 530000
- The First Affiliated Hospital of Guangxi University of Chinese Medicine
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Hebei
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Shijiazhuang, Hebei, Porcelana, 050000
- HeBei General Hosital
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Shijiazhuang, Hebei, Porcelana, 050000
- The Seond Hospital of HeBei Medical University
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Tangshan, Hebei, Porcelana, 063000
- Tangshan Gongren Hospital
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Heilongjiang
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Daqing, Heilongjiang, Porcelana, 163000
- DaQing General Hospial Group LongNan Hosptial
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Henan
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Kaifeng, Henan, Porcelana, 475000
- Kaifeng Central Hospital
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Zhengzhou, Henan, Porcelana, 450000
- The First Affiliated Hospital of Zhengzhou University
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Zhengzhou, Henan, Porcelana, 450000
- People's Hospital of Henan Province
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Zhengzhou, Henan, Porcelana, 450000
- The first affiliated hospital of henan university of TCM
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Zhengzhou, Henan, Porcelana, 450000
- The Second Affiliated Hospital of Henan University of TCM
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Zhengzhou, Henan, Porcelana, 450000
- The Second Affiliated Hospital of Zhengzhou University
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Hubei
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Shiyan, Hubei, Porcelana, 442000
- Taihe Hospital
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Wuhan, Hubei, Porcelana, 430000
- Renmin Hospital of Wuhan University
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Wuhan, Hubei, Porcelana, 430000
- Zhongnan Hospital of Wuhan University
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Wuhan, Hubei, Porcelana, 430000
- Hubei Provincial Corps Hospital of CPAPF
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Xiangyang, Hubei, Porcelana, 441100
- Xiangyang Central Hospital
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Hunan
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Changde, Hunan, Porcelana, 415000
- The First People's Hospital of Changde
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Changsha, Hunan, Porcelana, 410000
- The second Xiangya Hospital of Central South University
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Changsha, Hunan, Porcelana, 410000
- Xiangya Hospital Central-South University
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Hengyang, Hunan, Porcelana, 421000
- The First Affiliated Hospital of University of South China
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Jiangsu
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Nanjing, Jiangsu, Porcelana, 210000
- Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
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Nanjing, Jiangsu, Porcelana, 210000
- JiangSu Province Hosptial of TCM
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Nanjing, Jiangsu, Porcelana, 210000
- JiangSu Province Hosptial
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Nanjing, Jiangsu, Porcelana, 210000
- Nanjing First Hospital
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Nanjing, Jiangsu, Porcelana, 210000
- NanJing Hospital of TCM
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Suzhou, Jiangsu, Porcelana, 215000
- Suzhou Municipal Hospital
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Taizhou, Jiangsu, Porcelana, 225300
- Jiangsu Taizhou People's Hospital
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Wuxi, Jiangsu, Porcelana, 214000
- Wuxi People's Hospital
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Xuzhou, Jiangsu, Porcelana, 221000
- The Affiliated Hospital of Xuzhou Medical College
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Yangzhou, Jiangsu, Porcelana, 225000
- Northern Jiangsu People's Hospital
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Yangzhou, Jiangsu, Porcelana, 225000
- YangZhou No. 1 People's Hospital
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Jiangxi
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Nanchang, Jiangxi, Porcelana, 330000
- The Second Affiliated Hospital of Nanchang University
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Nanchang, Jiangxi, Porcelana, 330000
- The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
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Nanchang, Jiangxi, Porcelana, 330000
- The First Hospital of Nanchang
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Jilin
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Changchun, Jilin, Porcelana, 160000
- China-Japan Union Hospital of Jilin University
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Liaoning
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Anshan, Liaoning, Porcelana, 114000
- The First Hospital of China Medical University
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Dalian, Liaoning, Porcelana, 116000
- The 210th Hospital of Chinese people's Liberation Army
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Dalian, Liaoning, Porcelana, 116000
- The second people's Hospital of Dalian
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Shenyang, Liaoning, Porcelana, 110000
- Affiliated Hospital of LiaoNing University of Traditional Chinese Medicine
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Shenyang, Liaoning, Porcelana, 110000
- the Fourth Affiliated Hospital of China Medical University
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Shandong
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Jinan, Shandong, Porcelana, 250000
- Affiliated Hospital of Shandong University of TCM
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Jinan, Shandong, Porcelana, 250000
- Shangdong Provincial Hospital
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Linyi, Shandong, Porcelana, 276000
- Linyi People's Hospital
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Qinan, Shandong, Porcelana, 250000
- Qilu Hospital of Shandong University
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Qingdao, Shandong, Porcelana, 264000
- Qingdao University Medical College Affiliated Yuhuangding Hospital
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Yantai, Shandong, Porcelana, 266000
- The Affiliated Hospital of Medical College of Qingdao University
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Shanghai
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Shanghai, Shanghai, Porcelana, 200000
- Huadong Hospital Affiliated to Fudan University
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Shanghai, Shanghai, Porcelana, 200000
- Huashan Hospital Fudan University
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Shanghai, Shanghai, Porcelana, 200000
- Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
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Shanghai, Shanghai, Porcelana, 200000
- Shanghai East Hospital
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Shanghai, Shanghai, Porcelana, 200000
- Shanghai First People's Hospital
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Shanghai, Shanghai, Porcelana, 200000
- ShuGuang Hospital
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Shanghai, Shanghai, Porcelana, 200000
- Tongji hospital affiliated to tongji university
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Shanghai, Shanghai, Porcelana, 200000
- Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
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Shanghai, Shanghai, Porcelana, 200000
- Zhongshan Hospital Fudan University
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Shanxi
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Taiyuan, Shanxi, Porcelana, 030000
- Shanxi Medical University First Hospital
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Taiyuan, Shanxi, Porcelana, 030000
- Shanxi Medical University Second Hospital
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Sichuan
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Chengdu, Sichuan, Porcelana, 610000
- Sichuan Provincial People's Hospital
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Luzhou, Sichuan, Porcelana, 646000
- The Affiliated Hospital of Luzhou Medical College
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Nanchong, Sichuan, Porcelana, 637000
- Affiliated Hospital of Chuanbei Medical College
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Tianjin
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Tianjin, Tianjin, Porcelana, 300000
- The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
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Tianjin, Tianjin, Porcelana, 300000
- TianHe Hospital
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Tianjin, Tianjin, Porcelana, 300000
- Tianjin Chest Hospital
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Tianjin, Tianjin, Porcelana, 300000
- Tianjin Third Central Hospital
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Yunnan
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Kunming, Yunnan, Porcelana, 650000
- First People's Hospital of Yunnan Province
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Kunming, Yunnan, Porcelana, 650000
- Yunnan Provincial Hospital of Traditional Chinese Medicine
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Zhejiang
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Hangzhou, Zhejiang, Porcelana, 310000
- The Affiliated Hospital of Hangzhou Normal University
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Hangzhou, Zhejiang, Porcelana, 310000
- Hangzhou Traditional Chinese Medical Hospital
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Hangzhou, Zhejiang, Porcelana, 310000
- The First Affiliated Hospital Zhejiang University
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Hangzhou, Zhejiang, Porcelana, 310000
- Tongde Hospital of Zhejiang Province
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Hangzhou, Zhejiang, Porcelana, 310000
- Zhejiang Hospital
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Hangzhou, Zhejiang, Porcelana, 310000
- Zhejiang Provincial Hospital of TCM
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Ningbo, Zhejiang, Porcelana, 315000
- Ningbo First Hospital
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Ningbo, Zhejiang, Porcelana, 315000
- Ningbo Medical Treatment Center of LiHuiLi Hospital
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Wenzhou, Zhejiang, Porcelana, 325000
- The Second Hospital Affiliated to Wenzhou Medical College
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 85 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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
|
|
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Comparador de placebos: 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
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
The combined incidence of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke
Periodo de tiempo: 24 months
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24 months
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
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)
Periodo de tiempo: 24 months
|
24 months
|
Otras medidas de resultado
Medida de resultado |
Periodo de tiempo |
|---|---|
|
The incidence of adverse event
Periodo de tiempo: 24 months
|
24 months
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Junbo Ge, Doctor, Fudan University
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de julio de 2011
Finalización primaria (Anticipado)
1 de junio de 2015
Finalización del estudio (Anticipado)
1 de diciembre de 2015
Fechas de registro del estudio
Enviado por primera vez
9 de julio de 2013
Primero enviado que cumplió con los criterios de control de calidad
9 de julio de 2013
Publicado por primera vez (Estimar)
12 de julio de 2013
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
19 de diciembre de 2014
Última actualización enviada que cumplió con los criterios de control de calidad
17 de diciembre de 2014
Última verificación
1 de diciembre de 2014
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- TG0930BXW
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .