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Standard Medical Management in Secondary Prevention of Ischemic Stroke in China (SMART)
This study is currently recruiting participants.
Verified by Peking Union Medical College Hospital, September 2009
First Received: April 12, 2008   Last Updated: September 16, 2009   History of Changes
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.

Resource links provided by NLM:


Further study details as provided by Peking Union Medical College Hospital:

Primary Outcome Measures:
  • Success Rate of standard medical management [ Time Frame: 1 year after enrolled ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Ischemic stroke [ Time Frame: 1 year after enrolled ] [ Designated as safety issue: Yes ]
  • Non-fatal acute coronary syndrome [ Time Frame: 1 year after enrolled ] [ Designated as safety issue: Yes ]
  • Transient Ischemic Attack [ Time Frame: 1 year after enrolled ] [ Designated as safety issue: Yes ]
  • Hemorrhagic Stroke [ Time Frame: 1 year after enrolled ] [ Designated as safety issue: Yes ]
  • All-cause Death [ Time Frame: 1 year after enrolled ] [ Designated as safety issue: Yes ]

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
Criteria

Inclusion Criteria:

  1. Ischemic cerebral infarction or TIA within 30 days.
  2. Aged above 18 years old.
  3. Hospitalized.
  4. Cranial CT or MRI scan exclude intracranial hemorrhagic diseases
  5. Stable clinical and neurological conditions.
  6. A Modified Rankin score less than 4 at enrollment
  7. Informed consent is obtained.

Exclusion Criteria:

Patients will be excluded from entry if any of the criteria listed below are met

  1. Documented stroke caused by conditions other than atherosclerosis, ie, surgical or vascular intervention procedure.
  2. Severe co-morbid or unstable medical condition, ie, heart failure, respiratory failure and renal failure, severe liver dysfunction, malignancy with likelihood of death within the next 2 years
  3. Significant memory or behavioural disorder, ie, Alzheimer disease, etc, daily care needed.
  4. A Modified Rankin score is more than 4
  5. Concurrent participation in another clinical trial
  6. Pregnant
  7. Unable to give informed consent.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00664846

Contacts
Contact: Liying Cui 86-10-6529-6373 pumchcly@yahoo.com.cn
Contact: Bin Peng 86-10-6529-6371 pengbin3@hotmail.com

  Hide Study Locations
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    
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
Principal Investigator: Liying Cui Peking Union Medical College Hospital
  More Information

No publications provided

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

Keywords provided by Peking Union Medical College Hospital:
Stroke
Prevention Therapy

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on November 27, 2009