研究单位：[1]Fudan University[2]Shanghai Hutchison Pharmaceuticals Limited[3]AnHui Provincial Hospital,Hefei,Anhui,China,230000[4]The First Affiliated Hospital of Medical University Of Anhui,Hefei,Anhui,China,230000[5]MaAnShan Central Hospital,Maanshan,Anhui,China,243000[6]Beijing An Zhen Hospital of the Capital University of Medical Sciences,Beijing,China,100000[7]Beijing Hospital,Beijing,China,100000[8]Beijing Shijitan Hospital,Beijing,China,100000[9]Beijing Tongren Hospital Capital Medical University,Beijing,China,100000[10]Dongfang Hospital Affiliated to Beijing University of Chinese Medicine,Beijing,China,100000[11]Navi General Hospital,Beijing,China,100000[12]Peking University First Hospital,Beijing,China,100000[13]Armed police Chongqing Corps Hospital,Chongqing,Chongqing,China,400000[14]The Third People's Hospital of Chongqing,Chongqing,Chongqing,China,400000[15]FuJian Provincial Hospital,Fuzhou,Fujian,China,350000[16]People's Hospital of Fujian Province,Fuzhou,Fujian,China,350000[17]The Affiliated Hospital of PuTian University,Putian,Fujian,China,351100[18]XiaMen Heart Center,Xiamen,Fujian,China,361000[19]Affiliated Hospital of Guangzhou Medcal College,Guangzhou,Guangdong,China,510000[20]The First Affiliated Hospital of Guangzhou University of Chinese Medicine,Guangzhou,Guangdong,China,510000[21]The First Affiliated Hospital Sun Yat-sen University,Guangzhou,Guangdong,China,510000[22]The People's Hospital of Jiangmen,Jiangmen,Guangdong,China,529000[23]ShenZhen People's Hospital,Shenzhen,Guangdong,China,518000[24]The Affiliated Hospital of Guangdong Medical College,Zhanjiang,Guangdong,China,524000[25]The First People's Hospital of Liuzhou City,Liuzhou,Guangxi,China,545000[26]The First Affiliated Hospital Of GuangXi University Of Chinese Medicine,Nanning,Guangxi,China,530000[27]HeBei General Hosital,Shijiazhuang,Hebei,China,050000[28]The Seond Hospital of HeBei Medical University,Shijiazhuang,Hebei,China,050000[29]TangShan GongRen Hospital,Tangshan,Hebei,China,063000[30]DaQing General Hospial Group LongNan Hosptial,Daqing,Heilongjiang,China,163000[31]KaiFeng Central Hospital,Kaifeng,Henan,China,475000[32]People's Hospital of Henan Province,Zhengzhou,Henan,China,450000[33]The First Affiliated Hospital of Henan University of TCM,Zhengzhou,Henan,China,450000[34]The First Affiliated Hospital of Zhengzhou University,Zhengzhou,Henan,China,450000[35]The Second Affiliated Hospital of Henan University of TCM,Zhengzhou,Henan,China,450000[36]The Second Affiliated Hospital of Zhengzhou University,Zhengzhou,Henan,China,450000[37]Taihe Hospital,Shiyan,Hubei,China,442000[38]Hubei Provincial Corps Hospital of CPAPF,Wuhan,Hubei,China,430000[39]Renmin Hospital of Wuhan University,Wuhan,Hubei,China,430000[40]Zhongnan Hospital of Wuhan University,Wuhan,Hubei,China,430000[41]Xiangyang Central Hospital,Xiangyang,Hubei,China,441100[42]The First People's Hospital of Changde,Changde,Hunan,China,415000[43]The Second Xiangya Hospital of Central South University,Changsha,Hunan,China,410000[44]Xiangya Hospital Central-South University,Changsha,Hunan,China,410000[45]The First Affiliated Hospital of University of South China,Hengyang,Hunan,China,421000[46]JiangSu Province Hosptial of TCM,Nanjing,Jiangsu,China,210000[47]JiangSu Province Hosptial,Nanjing,Jiangsu,China,210000[48]NanJing Drum Tower Hospital The Affiliated Hospital of NanJing University Medical School,Nanjing,Jiangsu,China,210000[49]NanJing First Hospital,Nanjing,Jiangsu,China,210000[50]NanJing Hospital of TCM,Nanjing,Jiangsu,China,210000[51]SuZhou Municipal Hospital,Suzhou,Jiangsu,China,215000[52]JiangSu TaiZhou People's Hospital,Taizhou,Jiangsu,China,225300[53]WuXi People's Hospital,Wuxi,Jiangsu,China,214000[54]The Affiliated Hospital of XuZhou Medical College,Xuzhou,Jiangsu,China,221000[55]Northern JiangSu People's Hospital,Yangzhou,Jiangsu,China,225000[56]YangZhou No. 1 People's Hospital,Yangzhou,Jiangsu,China,225000[57]The Affiliated Hospital of JiangXi University of Traditional Chinese Medicine,Nanchang,Jiangxi,China,330000[58]The First Hospital of NanChang,Nanchang,Jiangxi,China,330000[59]The Second Affiliated Hospital of NanChang University,Nanchang,Jiangxi,China,330000[60]China-Japan Union Hospital of Jilin University,Changchun,Jilin,China,160000[61]The First Hospital Of China Medical University,Anshan,Liaoning,China,114000[62]The 210th Hospital of Chinese people's Liberation Army,Dalian,Liaoning,China,116000[63]The second people's Hospital of Dalian,Dalian,Liaoning,China,116000[64]Affiliated Hospital of Liaoning University of Traditional Chinese Medicine,Shenyang,Liaoning,China,110000[65]The Fourth Affiliated Hospital of China Medical University,Shenyang,Liaoning,China,110000[66]Affiliated Hospital of Shandong University of TCM,Jinan,Shandong,China,250000[67]Shangdong Provincial Hospital,Jinan,Shandong,China,250000[68]Linyi People's Hospital,Linyi,Shandong,China,276000[69]Qilu Hospital of Shandong University,Qinan,Shandong,China,250000[70]Qingdao University Medical College Affiliated Yuhuangding Hospital,Qingdao,Shandong,China,264000[71]The Affiliated Hospital of Medical College of Qingdao University,Yantai,Shandong,China,266000[72]Huadong Hospital Affiliated To Fudan University,Shanghai,Shanghai,China,200000[73]Huashan Hospital Fudan University,Shanghai,Shanghai,China,200000[74]Rui Jin Hospital Shanghai Jiao Tong University School of Medicine,Shanghai,Shanghai,China,200000[75]Shanghai East Hospital,Shanghai,Shanghai,China,200000[76]Shanghai First People's Hospital,Shanghai,Shanghai,China,200000[77]Shuguang Hospital,Shanghai,Shanghai,China,200000[78]Tongji Hospital Affiliated to Tongji University,Shanghai,Shanghai,China,200000[79]Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine,Shanghai,Shanghai,China,200000[80]Zhongshan hospital Fudan University,Shanghai,Shanghai,China,200000[81]Shanxi Medical University First Hospital,Taiyuan,Shanxi,China,030000[82]Shanxi Medical University Second Hospital,Taiyuan,Shanxi,China,030000[83]Sichuan Provincial People's Hospital,Chengdu,Sichuan,China,610000[84]The Affiliated Hospital of Luzhou Medical College,Luzhou,Sichuan,China,646000[85]Affiliated Hospital of Chuanbei Medical College,Nanchong,Sichuan,China,637000[86]The First Teaching Hospital of TianJin University of Traditional Chinese Medicine,Tianjin,China,300000[87]TianHe Hospital,Tianjin,China,300000[88]TianJin Chest Hospital,Tianjin,China,300000[89]Tianjin Third Central Hospital,Tianjin,China,300000[90]First People's Hospital of Yunnan Province,Kunming,Yunnan,China,650000[91]Yunnan Provincial Hospital of Traditional Chinese Medicine,Kunming,Yunnan,China,650000[92]Hangzhou Traditional Chinese Medical Hospital,Hangzhou,Zhejiang,China,310000[93]The Affiliated Hospital of Hangzhou Normal University,Hangzhou,Zhejiang,China,310000[94]The First Affiliated Hospital ZheJiang University,Hangzhou,Zhejiang,China,310000[95]Tongde Hospital of ZheJiang Province,Hangzhou,Zhejiang,China,310000[96]ZheJiang Hospital,Hangzhou,Zhejiang,China,310000[97]Zhejiang Provincial Hospital of TCM,Hangzhou,Zhejiang,China,310000[98]Ningbo First Hospital,Ningbo,Zhejiang,China,315000[99]Ningbo Medical Treatment Center of LiHuiLi Hospital,Ningbo,Zhejiang,China,315000[100]The Second Hospital Affiliated to Wenzhou Medical College,Wenzhou,Zhejiang,China,325000
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.
