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

Study Overview
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Brief Summary
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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.

Official Title
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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.

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 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

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 |
| --- | --- | --- |
| serum level of high sensitive CRP |  | until the last day of the next February after 5-year follow-up survey | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrent stroke |  | 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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statin, stroke, brain ischemia, cerebrovascular accident, hydroxymethylglutaryl-CoA reductase inhibitors, cholesterol, hypercholesterolemia, hyperlipidemia, multicenter studies, prospective studies, endpoint determination, randomized controlled trials, recurrence, pravastatin, c-reactive Protein