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Clinical Trial Details

Trial ID: L5888
Source ID: NCT00829660
Associated Drug: Acarbose
Title: Acarbose Cardiovascular Evaluation Trial
Acronym: ACE
Status: COMPLETED
Study Results: NO
Results:
Conditions: Coronary Heart Disease|Acute Coronary Syndrome|Impaired Glucose Tolerance|Type 2 Diabetes Mellitus (T2DM)
Interventions: DRUG: Acarbose|DRUG: Matching Placebo
Outcome Measures: Primary: A composite cardiovascular outcome defined as the time after randomisation to the first occurrence of any one of the following: -Cardiovascular death -Non-fatal MI -Non-fatal stroke -Hospitalisation for Unstable Angina -Hospitalisation for Heart Failure, Follow-up until 728 adjudicated Primary Outcome Measures have been recorded | Secondary: Transition to type 2 diabetes confirmed by two successive diagnostic plasma glucose values (FPG >7.0 mmol/l and/or 2HPG > 11.1 mmol/l), with no intervening non-diagnostic values.|All cause mortality|Each of the components of the primary composite cardiovascular outcome will also be analysed individually, both as first and as total events.|Major Cardiovascular Event (MACE) composite cardiovascular outcome, defined as the time after randomisation to the first occurrence of any one of the following: - Cardiovascular death - Non-fatal MI - Non-fatal stroke|Impaired renal function as evidenced by: A reduced estimate of glomerular filtration rate( eGFR <30 ml/minute/ 1.73 m2) estimated using the Chinese MDRD formula, a doubling of the baseline plasma creatinine level, a halving of the baseline eGFR|Resource use, costs and cost effectiveness
Sponsor/Collaborators: Sponsor: University of Oxford | Collaborators: Bayer
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 6526
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2009-02-17
Completion Date: 2017-04-18
Results First Posted:
Last Update Posted: 2017-07-25
Locations: The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, 230032, China|Beijing Chuiyangliu Hospital, Beijing, Beijing, 100022, China|China Meitan General Hospital, Beijing, Beijing, 100028, China|Beijing Anzhen Hospital of The Capital University of Medical Sciences, Beijing, Beijing, 100029, China|China-Japan Friendship Hospital, Beijing, Beijing, 100029, China|Peking University First Hospital, Beijing, Beijing, 100034, China|Beijing Ji Shui Tan Hospital, Beijing, Beijing, 100035, China|Beijing Shijitan Hospital, Beijing, Beijing, 100038, China|Fu Xing Hospital, Beijing, Beijing, 100038, China|Beijing Shijingshan Hospital, Beijing, Beijing, 100043, China|Peking University People's Hospital, Beijing, Beijing, 100044, China|Aerospace Central Hospital, Beijing, Beijing, 100049, China|Affiliated to The Capital University of Medical Sciences Beijing Friendship Hospital, Beijing, Beijing, 100050, China|Wangjing Hospital of CACMS, Beijing, Beijing, 100053, China|Xuanwu Hospital Capital Medical University, Beijing, Beijing, 100053, China|Beijing Healthy Palace Hospital, Beijing, Beijing, 100054, China|Aerospace 731 Hospital, Beijing, Beijing, 100074, China|General Hospital of Second Artillery PLA, Beijing, Beijing, 100088, China|Peking Union Medical College Hospital, Beijing, Beijing, 100730, China|PLA General Hospital, Beijing, Beijing, 100853, China|Anzhen Hospital of The Capital University of Medical Sciences 2nd., Beijing, Beijing, 101200, China|Beijing Pinggu Hospital, Beijing, Beijing, 101200, China|Beijing Yanhua Hospital, Beijing, Beijing, 102500, China|Chongqing Medical University Second Afflicated Hospital, Chongqing, Chongqing, 400010, China|Chongqing Zhongshan Hospital, Chongqing, Chongqing, 400013, China|Chongqing Third People's Hospital, Chongqing, Chongqing, 400014, China|The First Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing, 400016, China|Da Ping Hospital, Chongqing, Chongqing, 400042, China|The Second People's Hospital of Chongqing, Chongqing, Chongqing, 402160, China|Fujian Provincial Hospital, Fuzhou, Fujian, 350001, China|Union Hospital Affiliated to Fujian Medical University, Fuzhou, Fujian, 350001, China|The People's Hospital of Fujian Province, Fuzhou, Fujian, 350004, China|The First Hospital of Xiamen, Xiamen, Fujian, 361003, China|Zhongshan Hospital Xiamen University, Xiamen, Fujian, 361004, China|Guangdong General Hospital, Guangzhou, Guangdong, 510080, China|The First Affiliated Hospital of Guangdong Pharmaceutical University, Guangzhou, Guangdong, 510080, China|The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, Guangdong, 510080, China|Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, Guangdong, 510120, China|The Third Affiliated Hospital of Guangzhou Medical College, Guangzhou, Guangdong, 510150, China|Wu Jing Zhong Dui Hospital of Guangdong Province, Guangzhou, Guangdong, 510507, China|The First Affiliated Hospital of Jinan University, Guangzhou, Guangdong, 510630, China|Peking University Shenzhen Hospital, Shenzhen, Guangdong, 518036, China|Zhong Shan City People's Hospital, Zhongshan, Guangdong, 528403, China|The Fifth Affiliated Hospital of Sun Yat-Sen University, Zhuhai, Guangdong, 519000, China|Liuzhou Worker's Hospital, Liuzhou, Guangxi, 545005, China|Liuzhou People's Hospital, Liuzhou, Guangxi, 545006, China|Minzu Hospital of Guangxi Zhuang Autonomous Region, Nanning, Guangxi, 530001, China|303 Hospital of People's Liberation Army, Nanning, Guangxi, 530021, China|The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, 530021, China|The Affiliated Hospital of Guiyang Medical College, Guiyang, Guizhou, 550004, China|Cangzhou Central Hospital, Cangzhou, Hebei, 062650, China|The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, 050000, China|The First Hospital of Hebei Medical University, Shijiazhuang, Hebei, 050031, China|Bethune International Peace Hospital, Shijiazhuang, Hebei, 050082, China|Tangshan Workers Hospital, Tangshan, Hebei, 063000, China|The Affiliated Hospital of North China Coal Medical University, Tangshan, Hebei, 063000, China|Yu Tian County Hospital, Tangshan, Hebei, 064100, China|The Third Affiliated Hospital of Hebei North University, Zhangjiakou, Hebei, 075000, China|Da Qing Oilfield General Hospital, Da Qing, Heilongjiang, 163001, China|The Fourth Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, 150001, China|The First Affiliated Hospital of Henan Science & Technology University, Luoyang, Henan, 471003, China|Luo Yang Central Hospital, Affiliated to Zhengzhou University, Luoyang, Henan, 471009, China|The First Affiliated Hospital of Henan College of TCM, Zhengzhou, Henan, 450000, China|The People's Hospital of Zhengzhou, Zhengzhou, Henan, 450003, China|The Second Affiliated Hospital of Zhengzhou University, ZhengZhou, Henan, 450014, China|Union Hospital of Tongji Medical College of Huazhong, Wuhan, Hubei, 430022, China|Wuhan Asia Heart Hospital, Wuhan, Hubei, 430022, China|Tongji Hospital of Tongji Medical College of Huazhong, Wuhan, Hubei, 430030, China|Pu'ai Hospital of Wuhan City, Wuhan, Hubei, 430033, China|Renmin Hospital of Wuhan University, Wuhan, Hubei, 430060, China|Zhongnan Hospital of Wuhan University, Wuhan, Hubei, 430071, China|Hunan Provincial People's Hospital, Changsha, Hunan, 410005, China|The Fourth Hospital of Changsha, Changsha, Hunan, 410006, China|Xiangya Hospital Central-South University, Changsha, Hunan, 410008, China|The Third Hospital of Changsha, Changsha, Hunan, 410015, China|The First Affiliated Hospital of Baotou Medical College, Baotou, Inner Mongolia, 014010, China|Baotou Central Hospital, Baotou, Inner Mongolia, 014040, China|Chifeng Municipal Hospital, Chifeng, Inner Mongolia, 024000, China|Inner Mongolia Hospital, Hohhot, Inner Mongolia, 010017, China|81st Hospital of Chinese PLA, NanJing, Jiangsu, 210002, China|Nanjing First Hospital, Nanjing, Jiangsu, 210006, China|Nanjing Drum Tower Hospital, Nanjing, Jiangsu, 210008, China|Nanjing Zhongda Hospital, Nanjing, Jiangsu, 210009, China|BENQ Hospital, Nanjing, Jiangsu, 210017, China|Jiangsu Province Official Hospital, NanJing, Jiangsu, 210024, China|Jiangsu Province Hospital, Nanjing, Jiangsu, 210029, China|Jiangsu Provincial Hospital of TCM, NanJing, Jiangsu, 210029, China|Nanjing Jiangning Hospital, Nanjing, Jiangsu, 211100, China|Suzhou Municipal Hospital, Suzhou, Jiangsu, 215000, China|Wuxi No.2 People's Hospital, Wuxi, Jiangsu, 214002, China|Wuxi People's Hospital, Wuxi, Jiangsu, 214023, China|Wuxi No.3 People's Hospital, Wuxi, Jiangsu, 214041, China|Hospital Affiliated Xuzhou Medical University, Xuzhou, Jiangsu, 221000, China|The Second Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, 221006, China|Zhenjiang First People's Hospital, Zhenjiang, Jiangsu, 212002, China|Jiujiang University Hospital, Jiujiang, Jiangxi, 332000, China|Jiangxi Provincial People's Hospital, Nanchang, Jiangxi, 330006, China|The Second Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, 330006, China|The Third Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, 330008, China|China-Japan Union Hospital of Jilin University, Changchun, Jilin, 130033, China|The Second Hospital of Jilin University, Changchun, Jilin, 130041, China|The Central Hospital of Anshan, Anshan, Liaoning, 114001, China|Affiliated Zhongshan Hospital of Dalian University, Dalian, Liaoning, 116001, China|The First Hospital of Dalian Medical University, Dalian, Liaoning, 116011, China|Dalian Central Hospital, Dalian, Liaoning, 116033, China|Xianyang Central Hospital, Shengyang, Liaoning, 712000, China|Shengjing Hospital of China Medical University, Shenyang, Liaoning, 110004, China|The People's Hospital of Liaoning Province, Shenyang, Liaoning, 110016, China|Shengjing Hospital of China Medical University, Shenyang, Liaoning, 110021, China|The Fourth Hospital of China Medical University, Shenyang, Liaoning, 110032, China|The First Hospital of Yinchuan, Yinchuan, Ningxia, 750001, China|Affiliated Hospital of Ningxia Medical University, Yinchuan, Ningxia, 750004, China|The People's Hospital of Ningxia Hui Autonomous Region, Yinchuan, Ningxia, 750021, China|Xi'an Central Hospital, Xi'an, Shaanxi, 710003, China|The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, 710061, China|Affiliated Hospital of Xi'an Medical college, Xi'an, Shaanxi, 710077, China|Affiliated Hospital of Yan'an University, Yan'an, Shaanxi, 716000, China|Yan'an People's Hospital, Yanan, Shaanxi, 716000, China|The First Hospital of Yulin, Yulin, Shaanxi, 719000, China|The Central Hospital of Jinan, Jinan, Shandong, 250013, China|The First People's Hospital of Jinan, Jinan, Shandong, 250013, China|The General Hospital of Jinan Military Region, Jinan, Shandong, 250031, China|Linyi People's Hospital, Linyi, Shandong, 276003, China|Hospital Affiliated of Medical School, Qingdao University, Qingdao, Shandong, 266003, China|The Qingdao Municiple Hospital, Qingdao, Shandong, 266011, China|Qingdao Fuwai Hospital, Shibei, Shandong, 266034, China|Taian City Central Hospital, Taian, Shandong, 271000, China|Shanghai Ninth People's Hospital, Shanghai, Shanghai, 200011, China|Ruijin Hospital Affiliated to the Shanghai Jiaotong University Medical School, Shanghai, Shanghai, 200025, China|Shanghai Central Hospital of Xuhui District, Shanghai, Shanghai, 200031, China|Shanghai Zhongshan Hospital, Shanghai, Shanghai, 200032, China|Shanghai Huadong Hospital, Shanghai, Shanghai, 200040, China|Shanghai Putuo District People's Hospital, Shanghai, Shanghai, 200060, China|Putuo District Center Hospital, Shanghai, Shanghai, 200062, China|Tongji Hospital of Tongji University, Shanghai, Shanghai, 200065, China|Shanghai Tenth People's Hospital, Shanghai, Shanghai, 200072, China|Number 411 Hospital of PLA, Shanghai, Shanghai, 200081, China|Shanghai Central Hospital of Yangpu District, Shanghai, Shanghai, 200090, China|Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, Shanghai, 200092, China|Shanghai East Hospital, Shanghai, Shanghai, 200120, China|Renji Hospital Affilicated to Jiaotong University School of Medicine, Shanghai, Shanghai, 200127, China|Shanghai Pudong New Area Gongli Hospital, Shanghai, Shanghai, 200135, China|Changhai Hospital, Shanghai, Shanghai, 200433, China|Shanghai Zhabei District Shibei Hospital, Shanghai, Shanghai, 200435, China|Shanghai Jinshan Hospital, Shanghai, Shanghai, 200540, China|Shanghai Pudong New District People's Hospital, Shanghai, Shanghai, 201200, China|General Hospital of Tisco, Taiyuan, Shanxi, 030003, China|The Third Engineering Bureau Hospital of Ministry of Railway, Taiyuan, Shanxi, 030006, China|Taiyuan City Central Hospital, Taiyuan, Shanxi, 030009, China|Shanxi Cardiovascular Hospital, Taiyuan, Shanxi, 030024, China|PLA No.323 Hospital, Xi'an, Shanxi, 710054, China|Chengdu First People's Hospital, Chengdu, Sichuan, 610016, China|Chengdu Second People's Hospital, Chengdu, Sichuan, 610017, China|Sichuan Provincial People's Hospital, Chengdu, Sichuan, 610041, China|The West China Hospital, Chengdu, Sichuan, 610041, China|Sichuan Mianyang 404 Hospital, Sichuan, Sichuan, 621000, China|Tianjin Union Hospital, Tianjin, Tianjin, 300050, China|Tianjin Chest Hospital, Tianjin, Tianjin, 300051, China|Tianjin Union Medicine Centre, Tianjin, Tianjin, 300121, China|Army Police's Medical College Affiliated Hospital, Tianjin, Tianjin, 300162, China|Tianjin Third Central Hospital, Tianjin, Tianjin, 300170, China|Tianjin First Center Hospital, Tianjin, Tianjin, 300192, China|The Second Hospital of Tianjin Medical University, Tianjin, Tianjin, 300211, China|Dagang Oil-Field General Hospital, Tianjin, Tianjin, 300280, China|The Fifth Central Hospital of Tianjin, Tianjin, Tianjin, 300450, China|First Affiliated Hospital of the Medical College, Shihezi, Xinjiang, 832008, China|Xin Jiang Traditional Chinese Medicine Hospital, Urumqi, Xinjiang, 830000, China|General Hospital of Xinjiang Production and Construction Corps, Urumqi, Xinjiang, 830002, China|The 474th Hospital of PLA, Urumqi, Xinjiang, 830013, China|The First Teaching Hospital of Xinjiang Medical University, Urumqi, Xinjiang, 830054, China|The First Affiliated Hospital of Kunming Medical College, Kunming, Yunnan, 650032, China|The First People's Hospital of Yunnan Province, Kunming, Yunnan, 650032, China|The Second Affiliated Hospital of Kunming Medical College, Kunming, Yunnan, 650101, China|People's Hospital of Yuxi City, Yuxi, Yunnan, 653100, China|Zhe Jiang Hospital, Hangzhou, Zhejiang, 310013, China|Sir Run Run Shaw Hospital Affiliated With School of Medicine, Zhe Jiang University, Hangzhou, Zhejiang, 310016, China|Prince of Wales Hospital, Hong Kong, Hong Kong
URL: https://clinicaltrials.gov/show/NCT00829660