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

Completed

Phase 3 Results N/A

Trial Description

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.

Conditions

Interventions

  • Pravastatin (Pravachol┬«)Drug
    Intervention Desc: HMG-CoA reductase inhibitor; lowers cholesterol
  • Statin Drug
    Other Names: Pre-existing statin regimen
    ARM 1: Kind: Experimental
    Label: Pravastatin

Trial Design

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

Patient Involvement

Subject already enrolled in J-STARS and has had a lipid profile prior to being on a statin drug. Able to come into clinic for follow-up.

Outcomes

Type Measure Time Frame Safety Issue
Primary Serum level of high sensitive CRP.
Secondary Recurrent stroke.
Primary serum level of high sensitive CRP until the last day of the next February after 5-year follow-up survey
Secondary recurrent stroke until the last day of the next February after 5-year follow-up survey

Sponsors