Japan Statin Treatment Against Recurrent Stroke (J-STARS)

Completed

Phase 3 Results

Trial Description

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.

Conditions

Interventions

  • Pravastatin (Pravachol┬«)Drug
    ARM 1: Kind: Experimental
    Label: Pravastatin

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Prevention
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

Patients will be randomized into the group receiving pravastatin 10mg/day or that having no statin.

Outcomes

Type Measure Time Frame Safety Issue
Primary Cerebrovascular events.
Secondary Subtype of ischemic stroke according to the TOAST classification or hemorrhagic stroke, cardiovascular events including myocardial infarction, all the cerebrovascular and cardiovascular events, death of stroke, death of cerebrovascular and cardiovascular.
Primary cerebrovascular events until the last day of the next February after 5-year follow-up survey
Secondary subtype of ischemic stroke according to the TOAST classification or hemorrhagic stroke, cardiovascular events including myocardial infarction, all the cerebrovascular and cardiovascular events, death of stroke, death of cerebrovascular and cardiovascular until the last day of the next February after 5-year follow-up survey
Primary Incidence Rate of Stroke and TIA up to 5 years
Secondary Incidence Rate of Atherothrombotic Infarction up to 5 years
Secondary Incidence Rate of Lacunar Infarction up to 5 years
Secondary Incidence Rate of Cardioembolic Infarction up to 5 years
Secondary Incidence Rate of Intracranial Hemorrhage up to 5 years

Sponsors