Intensive Statin Treatment in Acute Ischemic Stroke Patients With INtracranial Atherosclerosis "STAMINA-MRI"

Recruiting

Phase 4 Results N/A

Trial Description

Purpose: Intracranial atherosclerosis is a common condition in Korean population consisting over 25% of ischemic stroke etiology. American Stroke Association and Korean Stroke Society recommend antiplatelet and statin for the treatment of intracranial atherosclerosis. Besides lowering blood cholesterol levels statin also stabilize atherosclerotic plaque and eventually lower the risk of ischemic stroke. However, little evidence resides on the effect of statin treatment on intracranial atherosclerosis. Recent advance in high-tesla magnetic resonance imaging enables direct imaging of intracranial atherosclerotic plaque and further assessment of treatment efficacy of statin in stabilization of intracranial atherosclerotic plaque became possible.

Conditions

Interventions

  • High-dose statin: Atorvastatin 40mg or Rosuvastatin 20mg Drug
    Other Names: Atorvastatin 40mg or Rosuvastatin 20mg
    Intervention Desc: Atorvastatin 40mg or Rosuvastatin 20mg
    ARM 1: Kind: Experimental
    Label: High-dose statin treatment
    Description: Atorvastatin (40mg) or Rosuvastatin (20mg)

Trial Design

  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Changes in vascular remodeling before and after the statin treatment During initial admission and 6 months from stroke onset No
Secondary Elevated liver function test or muscle enzyme levels During initial admission, an expected average of 1 week, and 1 and 3 month after discharge Yes
Secondary Recurrent stroke/Transient ischemic attack Admission to study completion date, an expected average of 1 year Yes
Secondary All causes of death Admission to study completion date, an expected average of 1 year Yes
Secondary Exploration of biomarkers During initial admission, an expected average of 1 week No

Sponsors