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Standard Medical Management in Secondary Prevention of Ischemic Stroke in China (SMART)
This study is currently recruiting participants.
Study NCT00664846   Information provided by Peking Union Medical College Hospital
First Received: April 12, 2008   Last Updated: September 16, 2009   History of Changes

April 12, 2008
September 16, 2009
April 2008
July 2010   (final data collection date for primary outcome measure)
Success Rate of standard medical management [ Time Frame: 1 year after enrolled ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00664846 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
 
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.

 
 
Interventional
Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Stroke
  • Drug: Aspirin / Clopidogrel, Atorvastatin / Simvastatin
  • Drug: Asprin / Clopidogrel, Atorvastatin / Simvastatin
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
5000
August 2010
July 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.
Both
18 Years and older
No
Contact: Liying Cui 86-10-6529-6373 pumchcly@yahoo.com.cn
Contact: Bin Peng 86-10-6529-6371 pengbin3@hotmail.com
China
 
NCT00664846
Liying Cui, Peking Union Medical College Hospital
2006BAI01A10-1
Peking Union Medical College Hospital
 
Principal Investigator: Liying Cui Peking Union Medical College Hospital
Peking Union Medical College Hospital
September 2009

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