Carotid Intima-media Thickness in Japan Statin Treatment Against Recurrent Stroke(J-STARS Echo)

Completed

Phase 3 Results N/A

Trial Description

Carotid ultrasound can reveal the intima-media complex thickness(IMT), that has been reported to be a marker of atherosclerosis as well as a risk of cardiovascular events, and to be attenuated by 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors (statins) . This substudy of J-STARS will observe the temporal profile of carotid IMT prospectively in the patients with prescription of pravastatin and the control.

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Intima-media complex thickness (IMT) of the common carotid artery (CCA).
Secondary Plaque score, number of plaque, recurrent cerebrovascular events.
Primary Intima-media complex thickness (IMT) of the common carotid artery (CCA) until the last day of the next February after 5-year follow-up survey
Secondary Plaque score, number of plaque, recurrent cerebrovascular events until the last day of the next February after 5-year follow-up survey

Sponsors