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 hsCRP in Japan Treatment Against Recurrent Stroke

 arrowOfficial Title
Effect of 3-Hydroxy-3-Methylglutaryl-Coenzyme A(HMG-CoA) Reductase Inhibitor Upon the Serum High Sensitive CRP in the Post-Ischemic Patients With Hyperlipidemia During the Prospective Study of J-STARS.

Inhibition of 3-hydroxy-3-methylglutaryl-coenzyme A(HMG-CoA) reductase can play
a role in preventing recurrent vascular events from ischemic heart disease patients, whose mechanism consists in not only the reduction of serum lipid level but also anti-inflammatory effects. Serum high sensitive CRP is known to be a predictor of cardiovascular events independent of other conventional risk factors. The present substudy examine whether such pleiotrophic effect of HMG-CoA reductase inhibitor (statin) which decreases high sensitive CRP would be observed in the post-ischemic stroke patients who have already been registered in the J-STARS, and the relationship the values of high sensitive CRP and recurrence of stroke.

 arrowPrimary Outcome Measures:
   serum level of high sensitive CRP

 arrowSecondary Outcome Measures:
   recurrent stroke

   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 filled in by the patient.

  ― 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

 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