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Trial record 45 of 461 for:    ASPIRIN AND clopidogrel AND ischemic

Standard Medical Management in Secondary Prevention of Ischemic Stroke in China (SMART)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00664846
Recruitment Status : Completed
First Posted : April 23, 2008
Last Update Posted : April 11, 2011
Sponsor:
Information provided by:
Peking Union Medical College Hospital

Tracking Information
First Submitted Date  ICMJE April 12, 2008
First Posted Date  ICMJE April 23, 2008
Last Update Posted Date April 11, 2011
Study Start Date  ICMJE April 2008
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 22, 2008)
Success Rate of standard medical management [ Time Frame: 1 year after enrolled ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00664846 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 22, 2008)
  • Ischemic stroke [ Time Frame: 1 year after enrolled ]
  • Non-fatal acute coronary syndrome [ Time Frame: 1 year after enrolled ]
  • Transient Ischemic Attack [ Time Frame: 1 year after enrolled ]
  • Hemorrhagic Stroke [ Time Frame: 1 year after enrolled ]
  • All-cause Death [ Time Frame: 1 year after enrolled ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Standard Medical Management in Secondary Prevention of Ischemic Stroke in China
Official Title  ICMJE Standard Medical Management in Secondary Prevention of Ischemic Stroke in China.
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Stroke
Intervention  ICMJE
  • 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) .
  • 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
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: Aspirin / Clopidogrel, Atorvastatin / Simvastatin
  • Active Comparator: 2
    Intervention: Drug: Asprin / Clopidogrel, Atorvastatin / Simvastatin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: July 23, 2010)
4000
Original Estimated Enrollment  ICMJE
 (submitted: April 22, 2008)
5000
Actual Study Completion Date  ICMJE April 2011
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00664846
Other Study ID Numbers  ICMJE 2006BAI01A10-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Liying Cui, Peking Union Medical College Hospital
Study Sponsor  ICMJE Peking Union Medical College Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Liying Cui Peking Union Medical College Hospital
PRS Account Peking Union Medical College Hospital
Verification Date February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP