Clinical Trial: Intensive Statin Treatment in Acute Ischemic Stroke Patients With INtracranial Atherosclerosis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Intensive Statin Treatment in Acute Ischemic Stroke Patients With INtracranial Atherosclerosis - High-Resolution Magnetic Resonance Imaging Study (STAMINA-MRI Study)

Brief Summary: 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.

Detailed Summary:
Sponsor: Samsung Medical Center

Current Primary Outcome: Changes in vascular remodeling before and after the statin treatment [ Time Frame: During initial admission and 6 months from stroke onset ]

Changes in vascular remodeling before and after the statin treatment: Difference of lumen area, vessel area, wall area, remodeling index, wall area index, plaque volume, plaque composition and enhancement pattern on high-resolution MRI


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Elevated liver function test or muscle enzyme levels [ Time Frame: During initial admission, an expected average of 1 week, and 1 and 3 month after discharge ]
    Abnormal laboratory findings of elevated liver function test or muscle enzyme levels
  • Recurrent stroke/Transient ischemic attack [ Time Frame: Admission to study completion date, an expected average of 1 year ]
  • All causes of death [ Time Frame: Admission to study completion date, an expected average of 1 year ]
    All causes of death including vascular and non-vascular death
  • Exploration of biomarkers [ Time Frame: During initial admission, an expected average of 1 week ]
    Lipid profile, lipoprotein(a), apoB/A1, extracellular vesicles, and genetic polymorphisms associated with statin response.


Original Secondary Outcome: Same as current

Information By: Samsung Medical Center

Dates:
Date Received: May 5, 2015
Date Started: February 2012
Date Completion: June 2018
Last Updated: April 25, 2017
Last Verified: October 2016