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| Sponsor: | Peking Union Medical College Hospital |
|---|---|
| Information provided by: | Peking Union Medical College Hospital |
| ClinicalTrials.gov Identifier: | NCT00664846 |
Purpose
The purposes of the study are to analyse the cross-section data of secondary stroke prevention in China and to carry out a standard medical management including medicine and interactive education program,and to evaluate the efficacy and safety of the standard medical management in secondary stroke prevention.
| Condition | Intervention |
|---|---|
|
Stroke |
Drug: Aspirin / Clopidogrel, Atorvastatin / Simvastatin Drug: Asprin / Clopidogrel, Atorvastatin / Simvastatin |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Standard Medical Management in Secondary Prevention of Ischemic Stroke in China. |
| Estimated Enrollment: | 5000 |
| Study Start Date: | April 2008 |
| Estimated Study Completion Date: | August 2010 |
| Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: Aspirin / Clopidogrel, Atorvastatin / Simvastatin
Standard Medical Management,including antiplatelet agents(Aspirin 75~150mg/day or Clopidogrel 75mg/day),statins(Atorvastatin 20mg/day or Simvastatin 20mg/day),risk factor lowering agents (antihypertension agents:Amlodipine 5mg/day or Benazepril 10mg/day or Valsartan 80mg/day or Nifedipine 30mg/day or Indapamide 2.5mg/day,antidiabetic agents: Metformin 0.5 tid or Glipizide 5mg tid or Acarbose 50mg tid )if necessary,interactive education program (Online medical education program, health behavior guide) .
|
| 2: Active Comparator |
Drug: Asprin / Clopidogrel, Atorvastatin / Simvastatin
Antiplatelet agents(Aspirin 75~150mg/day or Clopidogrel 75mg/day),statins(Atorvastatin 20mg/day or Simvastatin 20mg/day),risk factor lowering agents (antihypertension agents:Amlodipine 5mg/day or Benazepril 10mg/day or Valsartan 80mg/day or Nifedipine 30mg/day or Indapamide 2.5mg/day,antidiabetic agents: Metformin 0.5 tid or Glipizide 5mg tid or Acarbose 50mg tid )if necessary
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Patients will be excluded from entry if any of the criteria listed below are met
Contacts and Locations| Contact: Liying Cui | 86-10-6529-6373 | pumchcly@yahoo.com.cn |
| Contact: Bin Peng | 86-10-6529-6371 | pengbin3@hotmail.com |
Hide Study Locations| China | |
| China Pla General Hospital | Recruiting |
| Beijing, China, 100853 | |
| Contact: Chenglin Tian tianchenglin719@yahoo.com.cn | |
| Beijing Tiantan Hospital | Recruiting |
| Beijing, China | |
| Contact: Yong Zhou yongzhou78214@163.com | |
| Xuanwu Hospital Capital Medical University | Recruiting |
| Beijing, China | |
| Contact: Jianping Jia jiajp@vip.sina.com | |
| Peking University Third Hospital | Recruiting |
| Beijing, China | |
| Contact: Jun Zhang Who626@163.com | |
| China Rehabilition Research Center | Recruiting |
| Beijing, China | |
| Contact: Jun Zhao zaojun@sohu.com | |
| No 263 Hospital of Pla | Recruiting |
| Beijing, China | |
| Contact: Jinli Zhang hi1044@163.com | |
| Beijing Ji Shui Tan Hospital,the 4TH Medical College of Peking University | Recruiting |
| Beijing, China | |
| Contact: Yuheng Sun yuhengs@126.com | |
| Beijing Daxing District Hospital | Recruiting |
| Beijing, China | |
| Contact: Liuzhuang Zhao Zlz66@yahoo.com.cn | |
| Luhe Hospital of Tongzhou Distict Beijing | Recruiting |
| Beijing, China | |
| Contact: Huishan Du smashxk@msn.com | |
| General Hospital of Navy | Recruiting |
| Beijing, China | |
| Contact: Xiaokun Qi bjqxk@sina.com | |
| Beijing Shijitan Hospital | Recruiting |
| Beijing, China | |
| Contact: Huiwen Xu xhwdoctor@163.com | |
| No 309 Hospital of Pla | Recruiting |
| Beijing, China | |
| Contact: Yuping Chen leafcyp@163.com | |
| Pinggu County Hospital Beijing | Recruiting |
| Beijing, China | |
| Contact: Guiyun Zhang pgzhangguiyun@2008.sina.com | |
| Peking Union Medical College Hosptial | Recruiting |
| Beijing, China, 100730 | |
| Contact: Liying Cui 86-10-65296373 pumchcly@yahoo.com.cn | |
| Contact: Bin Peng 86-10-65296371 pengbin3@hotmail.com | |
| Daping Hospital | Recruiting |
| Chongqing, China | |
| Contact: Huadong Zhou Zhouhuadong@163.com | |
| Southwest Hospital | Recruiting |
| Chongqing, China | |
| Contact: Shugui Shi southwestneuro@163.com | |
| Shanghai Changzheng Hospital | Recruiting |
| Shanghai, China | |
| Contact: Xiaoyan Chen abilitywin@163.com | |
| Huashan Hospital Fudan University | Recruiting |
| Shanghai, China | |
| Contact: Liang Wang autum88_cn@yahoo.com | |
| the General Hospital Under Tianjin Medical Sciences University | Recruiting |
| Tianjin, China | |
| Contact: Yan Cheng cylfl@sohu.com | |
| Tianjin Third Central Hospital | Recruiting |
| Tianjin, China | |
| Contact: Zhecheng Zhang zzc0912@yahoo.com.cn | |
| China, Guangdong | |
| Guangzhou First Municipal People's Hospital | Recruiting |
| Guangzhou, Guangdong, China | |
| Contact: Mengyan Li | |
| the First Affiliated Hospital,Sun Yat-sen Unversity | Recruiting |
| Guangzhou, Guangdong, China | |
| Contact: Hua Hong hhsums@163.com | |
| China, Hebei | |
| Hebei North University | Recruiting |
| Zhangjiakou, Hebei, China | |
| Contact: Shumin Yue yuesm6903@sina.com | |
| the Second Hospital of Hebei Medical University | Recruiting |
| Shijiazhuang, Hebei, China | |
| Contact: Zhenzhong Li johndoctor@126.com | |
| Yutian County Hospital | Recruiting |
| Yutian, Hebei, China | |
| Contact: Jinchao Wang 86-0315-6158126 | |
| the First Hospital of Hebei Medical University | Recruiting |
| Shijiazhuang, Hebei, China | |
| Contact: Mingwei Wang wmw@hebmu.edu.cn | |
| the Third Hospital of Hebei Medical University | Recruiting |
| Shijiazhuang, Hebei, China | |
| Contact: Junyan Liu junyanliu2003@yahoo.com.cn | |
| China, Helongjiang | |
| the First Hospital of Harbin Medical University | Recruiting |
| Harbin, Helongjiang, China | |
| Contact: Weizhi Wang wwz_h2008@yahoo.com.cn | |
| the Second Hospital of Harbin Medical University | Recruiting |
| Harbin, Helongjiang, China | |
| Contact: Liming Zhang zfx001@yahoo.com | |
| China, Henan | |
| Henan Provincial People's Hospital | Recruiting |
| Zhengzhou, Henan, China | |
| Contact: Jiewen Zhang zhangjiewen9900@126.com | |
| China, Hubei | |
| the Zhongnan Hospital of Wuhan University | Recruiting |
| Wuhan, Hubei, China | |
| Contact: Junjian Zhang wdsjkx@yahoo.com.cn | |
| China, Hunan | |
| Xiangya Hospital of Centre-south University | Recruiting |
| Changsha, Hunan, China | |
| Contact: Jian Xia xiajian1216@sina.com | |
| China, Inner Mongolia | |
| Inner Mongolia Baotou City Central Hospital | Recruiting |
| Baotou, Inner Mongolia, China | |
| Contact: Jingfen Zhang zhangjingfen@263.sina.com | |
| the Appurtenant Hospital of Chifeng University | Recruiting |
| Chifeng, Inner Mongolia, China | |
| Contact: Qifu Cui Cxb1986@sina.com | |
| China, Jiangsu | |
| Jiangsu Province Hospital | Recruiting |
| Nanjing, Jiangsu, China | |
| Contact: Xinsheng Ding xsding@publicl.ptt.js.cn | |
| the Affiliated Drumtower Hospital of Nanjing University Medical School | Recruiting |
| Nanjing, Jiangsu, China | |
| Contact: Yun Xu xuyun20042001@yahoo.com.cn | |
| Nanjing General Hospital of Nanjing Military Command | Recruiting |
| Nanjing, Jiangsu, China | |
| Contact: Gelin Xu gelinxu@gmail.com | |
| China, Jilin | |
| Jilin University | Recruiting |
| Changchun, Jilin, China | |
| Contact: Jiang Wu sjnkwujing@sina.com | |
| China, Liaoning | |
| the First Affiliated Hospital of China Medical Sciences University | Recruiting |
| Shenyang, Liaoning, China | |
| Contact: Chaodong Zhang xczhang@163.com | |
| the Third People's Hospital of Dalian | Recruiting |
| Dalian, Liaoning, China | |
| Contact: Jingbo Zhang dlzhangjingbo@163.com | |
| China, Qinghai | |
| Qinghai Provincial People's Hospital | Recruiting |
| Xining, Qinghai, China | |
| Contact: Jinpeng Wang qhwjp@yahoo.com.cn | |
| China, Shandong | |
| Qilu Hospital of Shangdong University | Recruiting |
| Jinan, Shandong, China | |
| Contact: Shuzhen Wang xxwsz63@yahoo.com.cn | |
| the Second Hospitalof Shangdong University | Recruiting |
| Jinan, Shandong, China | |
| Contact: Wei Shang wshang85@yahoo.com.cn | |
| China, Sichuan | |
| West China Center of Medical Sciences | Recruiting |
| Chengdu, Sichuan, China | |
| Contact: Dong Zhou zhoudong66@yahoo.de | |
| China, Xinjiang uygur autonomous region | |
| First Affiliated Hospital of Xinjiang Medical University | Recruiting |
| Uramuqi, Xinjiang uygur autonomous region, China | |
| Contact: Xiaoning Zhang zxn-1960@163.com | |
| China, Zhejiang | |
| the First Affiliated Hospital of College of Medicine, Zhejiang University | Recruiting |
| Hangzhou, Zhejiang, China | |
| Contact: Jianwen Wang warrington@126.com | |
| Principal Investigator: | Liying Cui | Peking Union Medical College Hospital |
More Information
| Responsible Party: | Peking Union Medical College Hospital ( Liying Cui ) |
| Study ID Numbers: | 2006BAI01A10-1 |
| Study First Received: | April 12, 2008 |
| Last Updated: | September 16, 2009 |
| ClinicalTrials.gov Identifier: | NCT00664846 History of Changes |
| Health Authority: | China: Ministry of Health |
|
Stroke Prevention Therapy |
|
Antimetabolites Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Cerebral Infarction Hematologic Agents Physiological Effects of Drugs Fibrinolytic Agents Brain Diseases Cerebrovascular Disorders Fibrin Modulating Agents Aspirin Sensory System Agents Therapeutic Uses Brain Ischemia Cardiovascular Diseases |
Anti-Inflammatory Agents, Non-Steroidal Analgesics Simvastatin Antilipemic Agents Cyclooxygenase Inhibitors Nervous System Diseases Stroke Vascular Diseases Central Nervous System Diseases Enzyme Inhibitors Anticholesteremic Agents Cardiovascular Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions Analgesics, Non-Narcotic |