Japan Statin Treatment Against Recurrent Stroke (J-STARS)

Study Overview
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Brief Summary
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Although hyperlipidemia is not always the risk factor of stroke, inhibition of 3-hydroxy-3-methylglutaryl-coenzyme A(HMG-CoA) reductase can decrease the incidence of stroke in the patient with ischemic heart disease. The neuroprotective mechanism beyond cholesterol lowering should be expected to attenuate inflammation and atherosclerosis. The present study hypothesizes if pravastatin prevents recurrent stroke in the ischemic stroke patients with safety.

Official Title
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Secondary Prevention With HMG-CoA Reductase Inhibitor Against Stroke

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Drug: Pravastatin


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

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: Pravastatin<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 |
| --- | --- | --- |
| Incidence Rate of Stroke and TIA | Incidence rate of patients with recurrent stroke of any type or transient ischemic attack (TIA) | up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence Rate of Atherothrombotic Infarction | Incidence rate of patients with atherothrombotic infarction | up to 5 years | 
| Incidence Rate of Lacunar Infarction | Incidence rate of patients with lacunar infarction | up to 5 years | 
| Incidence Rate of Cardioembolic Infarction | Incidence rate of patients with cardioembolic infarction | up to 5 years | 
| Incidence Rate of Intracranial Hemorrhage | Incidence rate of patients with intracranial hemorrhage | up to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, brain ischemia, cerebrovascular accident, statin, hydroxymethylglutaryl-CoA reductase inhibitors, cholesterol, hypercholesterolemia, hyperlipidemia, multicenter studies, prospective studies, endpoint determination, randomized controlled trials, recurrence, pravastatin