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hsCRP in Japan Statin Treatment Against Recurrent Stroke (J-STARS hsCRP)

This study is currently recruiting participants.
Information provided by Translational Research Informatics Center, Kobe, Hyogo, Japan

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Descriptive Information Fields
Brief Title  hsCRP in Japan Statin Treatment Against Recurrent Stroke (J-STARS hsCRP)
Official 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.
Brief Summary

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.

Detailed Description
Study Phase Phase III
Study Type  Interventional
Study Design  Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measure  serum level of high sensitive CRP
Secondary Outcome Measure  recurrent stroke
Condition  Ischemic Stroke
Intervention  Drug: Pravastatin
MEDLINE PMIDs
Links Available only in Japanese This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  1200
Start Date  March 2004
Completion Date February 2014
Eligibility Criteria 

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
Gender Both
Ages 45 Years to 80 Years
Accepts Healthy Volunteers No
Contacts ††
Contact: Masayasu Matsumoto, MD, PhD     +81-82-257-5201     mack@hiroashima-u.ac.jp    
Contact: Tatsuo Kohriyama, MD, PhD     +81-82-257-5201     jstars-office@umin.ac.jp    
Location Countries  Japan
Administrative Information Fields
NCT ID  NCT00361699
Organization ID J-STARS hsCRP
Secondary IDs ††
Study Sponsor  Translational Research Informatics Center, Kobe, Hyogo, Japan
Collaborators †† Japanese Ministry of Health, Labor and Welfare
Hiroshima University
Osaka University
Investigators 
Principal Investigator:     Masayasu Matsumoto, MD, PhD     Hiroshima University Hospital    
Information Provided By Translational Research Informatics Center, Kobe, Hyogo, Japan
Verification Date June 2007
First Received Date  August 7, 2006
Last Updated Date June 15, 2007

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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