Intensive Statin Treatment in Acute Ischemic Stroke Patients With INtracranial Atherosclerosis

Study Overview
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Brief Summary
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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.

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

Conditions
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Stroke, Intracranial Atherosclerosis

Intervention / Treatment
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* Drug: High-dose statin: Atorvastatin 40mg or Rosuvastatin 20mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute ischemic stroke patients within 7 days of symptom onset Symptomatic intracranial artery stenosis (above 30%) at proximal portion of middle cerebral artery (MCA), basilar artery, or intracranial portion of intracranial artery (ICA). Not receiving statins (HMA-coA reductase) Willing and able to comply with scheduled visits, lifestyle guidelines, treatment plan, laboratory tests, and other study procedures. Exclusion Criteria: Extracranial artery (carotid artery bifurcation, proximal vertebral artery) stenosis above 50% Stroke attributable to cardioembolic origin (atrial fibrillation, valvular heart disease, aortic arch atherosclerosis) Severe hepatic or renal dysfunction Pregnant females as determined by positive urine hCG test or lactating females Subjects considered unwilling or unable to comply with the imaging procedures and study visit schedule

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High-dose statin treatment<br>Atorvastatin (40mg) or Rosuvastatin (20mg) | Drug: High-dose statin: Atorvastatin 40mg or Rosuvastatin 20mg<br>* Atorvastatin 40mg or Rosuvastatin 20mg<br>* Other names: Atorvastatin 40mg or Rosuvastatin 20mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in vascular remodeling before and after the statin treatment | 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 | During initial admission and 6 months from stroke onset | 

Secondary Outcome Measures

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