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Japan Statin Treatment Against Recurrent Stroke

arrowOfficial Title
   Secondary Prevention With HMG-CoA Reductase Inhibitor Against Stroke

  Although hyperlipidemia is not always listed as a risk factor of strokes, inhibition of 3hydroxy-3-methylglutaryl-coenzyme A(HMG-CoA) reductase can decrease the incidence of stroke in the patient with ischemic heart disease.
  The neuroprotective mechanism beyond cholesterol lowering should be expected to attenuate
inflammation and atherosclerosis. The present study hypothesizes if pravastatin prevents recurrent stroke
in the ischemic stroke patients with safety.

arrowPrimary Outcome Measures: cerebrovascular events

arrowSecondary Outcome Measures:
   subtype of ischemic stroke according to the TOAST classification or hemorrhagic stroke, cardiovascular events including myocardial infarction, all the cerebrovascular and cardiovascular events, death of stroke, death of cerebrovascular and cardiovascular

   Estimated Enrollment:


   Study Start Date:

March 2004

   Estimated Study Completion Date:

February 2014

   ・Ages Eligible for Study: 45 Years to 80 Years
   ・Genders Eligible for Study: Both
   ・Accepts Healthy Volunteers: No
  ― Inclusion Criteria:
   ・Ischemic stroke except for cardiogenic embolism, from 1 month to 3 years after onset   
   ・Hyperlipidemia and total cholesterol level of 180-240mg/dl without the prescription of
    statin within previous 30 days
   ・ Able to visit outpatient department
   ・Informed consent on the form.  
 ― Exclusion Criteria:

   ・Ischemic stroke of other determined cause according to the TOAST classification
   ・Ischemic heart disease and necessary to use statin
   ・Hemorrhagic disorders
   ・Platelet count <=100,000/ul within 3 months prior to study start
   ・Alanine aminotransferase (ALT) or aspartate aminotransferase (AST)>= 100IU/L
    within 3 months prior to study start
   ・Serum creatinine >=2.0mg/dl within 3 months prior to study start
   ・A scheduled operation
   ・The presence of malignant disorder
arrowStudy Design:
   ・Allocation: Randomized
   ・Control: Active Control
   ・ Endpoint Classification: Safety/Efficacy Study
   ・Intervention Model: Parallel Assignment
   ・Masking: Open Label
   ・Primary Purpose: Prevention

 arrow The Status: As of August 2012

 arrowAdditional Information:

    Stroke Trial Registry


J-STARS Office
Address:1-2-3 Kasumi Minami-ku
Hiroshima, Japan 734-8551 
Phone: +81-82-257-5201  FAX: +81-82-505-0490

apan Statin Treatment Against Recurrent Stoke
Department of Clinical Neuroscience & Therapeutics 
               Hiroshima University Graduate School of Biomedical Science
Masayasu Matsumoto MD, PhD