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

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan1,095 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

1,095

Conditions

Ischemic Stroke

Interventions

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 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

Outcomes

Primary Outcomes

serum level of high sensitive CRP

Time frame: until the last day of the next February after 5-year follow-up survey

Secondary Outcomes

recurrent stroke