Carotid Intima-media Thickness in Japan Statin Treatment Against Recurrent Stroke(J-STARS Echo)

Study Overview
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Brief Summary
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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.

Official Title
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Effect of 3-hydroxy-3-methylglutaryl-coenzyme A(HMG-CoA) Reductase Inhibitor Upon Carotid Intima-media Complex Thickness in the Post-ischemic Patients With Hyperlipidemia During the Prospective Study of J-STARS.

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Drug: Statin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pravastatin<br>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. | Drug: Statin<br> <br> |
| No Intervention: No intervention<br>Patient has no intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intima-media complex thickness (IMT) of the common carotid artery (CCA) |  | until the last day of the next February after 5-year follow-up survey | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plaque score, number of plaque, recurrent cerebrovascular events |  | until the last day of the next February after 5-year follow-up survey | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hyperlipidemia, stroke, brain ischemia, cerebrovascular accident, statin, cholesterol, hypercholesterolemia, multicenter studies, prospective studies, endpoint determination, randomized controlled trials, recurrence, pravastatin, plaque, tunica intima, tunica media, ultrasonography, carotid arteries, hydroxymethylglutaryl-CoA Reductase Inhibitors