Evidence for a Novel
Treatment Method

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  J-STARS (Echo)  
Carotid Intima-Media Thickness in Japan Stain Treatment Against Recurrent Stroke

arrowOfficial Title
   Effect of 3-Hydroxy-3-Methylglutaryl-Coenzyme A(HMG-CoA) Reductase Inhibitor
  Upon Carotid Intima-Media Complex Thickness in the Post-Ischemic Patients With Hyperlipidemia
  During the Prospective Study of J-STARS.
    Carotid ultrasound can reveal the intima-media complex thickness(IMT), that has been reported
  to be a marker of atherosclerosis as well as a risk of cardiovascular events, and to be attenuated by
  3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors (statins) . This substudy
  of J-STARS will observe the temporal profile of carotid IMT prospectively in the patients with   
  prescription of pravastatin and the control.
arrowPrimary Outcome Measures:
   Intima-media complex thickness (IMT) of the common carotid artery (CCA)

arrowSecondary Outcome Measures:
   Plaque score, number of plaque, recurrent cerebrovascular events

  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:  


  Accepts Healthy Volunteers:  


  ― 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
   ・Patients whom carotid ultrasound cannot examine because of neck tumor or torticollis
   ・Patients after carotid endarterectomy or radiation therapy to neck
   ・Patients whose carotid ultrasound cannot be examined because of neck tumor or torticollis
   ・Patients after carotid endarterectomy or radiation therapy to neck  

arrowStudy Design:Allocation: Randomized
   ・Control: Active Control
   ・Endpoint Classification: Safety/Efficacy Study
   ・Intervention Model: Parallel Assignment
   ・Masking: Open Label
   ・Primary Purpose: Prevention


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