 Official Title
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Purpose
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.
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Primary Outcome Measures:
Intima-media complex thickness (IMT) of the common carotid artery (CCA)
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Secondary Outcome Measures:
Plaque score, number of plaque, recurrent cerebrovascular events
Estimated Enrollment: |
800 |
Study Start Date: |
March 2004 |
Estimated Study Completion Date: |
February 2014 |
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Eligibility
| Ages Eligible for Study: |
45 Years to 80 Years |
Genders Eligible for Study: |
Both |
Accepts Healthy Volunteers: |
No |
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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.
― 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
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Study Design:Allocation: Randomized
・Control: Active Control
・Endpoint Classification: Safety/Efficacy Study
・Intervention Model: Parallel Assignment
・Masking: Open Label
・Primary Purpose: Prevention
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Clinical Trials.gov
http://clinicaltrials.gov/ct2/show/study?term=J-STARS&rank=2
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