Japan Statin Treatment Against Recurrent Stroke (J-STARS)

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan1,578 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

1,578

Conditions

Ischemic Stroke

Interventions

PravastatinDRUG

Eligibility

Sex: ALLMin age: 45 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Hiroshima University

Hiroshima, Japan

Outcomes

Primary Outcomes

Incidence Rate of Stroke and TIA

Incidence rate of patients with recurrent stroke of any type or transient ischemic attack (TIA)

Time frame: up to 5 years

Secondary Outcomes

Incidence Rate of Atherothrombotic Infarction

Incidence rate of patients with atherothrombotic infarction

Time frame: up to 5 years

Incidence Rate of Lacunar Infarction

Incidence rate of patients with lacunar infarction

Time frame: up to 5 years

Incidence Rate of Cardioembolic Infarction

Incidence rate of patients with cardioembolic infarction

Time frame: up to 5 years

Incidence Rate of Intracranial Hemorrhage

Incidence rate of patients with intracranial hemorrhage

Time frame: up to 5 years

Data from ClinicalTrials.gov

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