Intracranial Atherosclerosis, Stroke
Conditions
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.
Interventions
DRUGHigh-dose statin: Atorvastatin 40mg or Rosuvastatin 20mg
Atorvastatin 40mg or Rosuvastatin 20mg
Sponsors
Don-A Pharmaceutical, Seoul, South Korea
Samsung Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in vascular remodeling before and after the statin treatment | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Elevated liver function test or muscle enzyme levels | 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 | Admission to study completion date, an expected average of 1 year | — |
| All causes of death | Admission to study completion date, an expected average of 1 year | All causes of death including vascular and non-vascular death |
| Exploration of biomarkers | During initial admission, an expected average of 1 week | Lipid profile, lipoprotein(a), apoB/A1, extracellular vesicles, and genetic polymorphisms associated with statin response. |
Countries
South Korea
Contacts
Primary ContactOh Young Bang, MD, PhD
Backup ContactJong-Won Chung, MD, Msc
Outcome results
None listed