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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Ministry of Health, Labour and Welfare, Japan
Hiroshima University
Osaka University
Information provided by (Responsible Party):
Translational Research Informatics Center, Kobe, Hyogo, Japan
ClinicalTrials.gov Identifier:
NCT00361699
First received: August 7, 2006
Last updated: May 13, 2014
Last verified: May 2014

August 7, 2006
May 13, 2014
March 2004
July 2014   (final data collection date for primary outcome measure)
serum level of high sensitive CRP [ Time Frame: until the last day of the next February after 5-year follow-up survey ] [ Designated as safety issue: No ]
serum level of high sensitive CRP
Complete list of historical versions of study NCT00361699 on ClinicalTrials.gov Archive Site
recurrent stroke [ Time Frame: until the last day of the next February after 5-year follow-up survey ] [ Designated as safety issue: No ]
recurrent stroke
Not Provided
Not Provided
 
hsCRP in Japan Statin Treatment Against Recurrent Stroke (J-STARS hsCRP)
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Ischemic Stroke
Drug: Statin
  • Active Comparator: Pravastatin
    Patient has 10mg oral administration of Pravastatin per day. It starts within one month from their entry and continues every day until the end of the study or its endpoints.
    Intervention: Drug: Statin
  • No Intervention: No intervention
    Patient has no intervention.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1095
July 2014
July 2014   (final data collection date for primary outcome measure)

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
Both
45 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00361699
J-STARS hsCRP, C000000211
Not Provided
Translational Research Informatics Center, Kobe, Hyogo, Japan
Translational Research Informatics Center, Kobe, Hyogo, Japan
  • Ministry of Health, Labour and Welfare, Japan
  • Hiroshima University
  • Osaka University
Principal Investigator: Masayasu Matsumoto, MD, PhD Hiroshima University Hospital
Translational Research Informatics Center, Kobe, Hyogo, Japan
May 2014

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