Title
Japan Statin Treatment Against Recurrent Stroke (J-STARS)
Secondary Prevention With HMG-CoA Reductase Inhibitor Against Stroke
Phase
Phase 3Study Type
InterventionalStatus
Completed Results PostedIndication/Condition
Ischemic StrokeIntervention/Treatment
pravastatin ...Study Participants
1578Although 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.
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.
Patient has no intervention.
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
| Event Type | Organ System | Event Term | Pravastatin Group | Control Group |
|---|
Incidence rate of patients with recurrent stroke of any type or transient ischemic attack (TIA)
Incidence rate of patients with atherothrombotic infarction
Incidence rate of patients with lacunar infarction
Incidence rate of patients with cardioembolic infarction
Incidence rate of patients with intracranial hemorrhage
