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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00664846
First Posted: April 23, 2008
Last Update Posted: April 11, 2011
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.
Information provided by:
Peking Union Medical College Hospital
April 12, 2008
April 23, 2008
April 11, 2011
April 2008
December 2010   (Final data collection date for primary outcome measure)
Success Rate of standard medical management [ Time Frame: 1 year after enrolled ]
Same as current
Complete list of historical versions of study NCT00664846 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Standard Medical Management in Secondary Prevention of Ischemic Stroke in China
Standard Medical Management in Secondary Prevention of Ischemic Stroke in China.
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Stroke
  • 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
  • Experimental: 1
    Intervention: Drug: Aspirin / Clopidogrel, Atorvastatin / Simvastatin
  • Active Comparator: 2
    Intervention: Drug: Asprin / Clopidogrel, Atorvastatin / Simvastatin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4000
April 2011
December 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT00664846
2006BAI01A10-1
No
Not Provided
Not Provided
Liying Cui, Peking Union Medical College Hospital
Peking Union Medical College Hospital
Not Provided
Principal Investigator: Liying Cui Peking Union Medical College Hospital
Peking Union Medical College Hospital
February 2011

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