 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.
Purpose
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.
Primary Outcome Measures:
serum level of high sensitive CRP
Secondary Outcome Measures:
recurrent stroke
| Estimated Enrollment: |
1200 |
Study Start Date: |
March 2004 |
Estimated Study Completion Date: |
February 2014 |
Eligibility
| Ages Eligible for Study: |
45 Years to 80 Years |
Genders Eligible for Study: |
Both |
Accepts Healthy Volunteers: |
No |
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
Study Design:
Allocation: Randomized
Control: Active Control
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Clinical Trials.gov
http://clinicaltrials.gov/ct2/show/study?term=J-STARS&rank=1
Stroke Trial Registry
http://www.strokecenter.org/trials/TrialDetail.aspx?tid=779
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