Intensive Statin Treatment in Acute Ischemic Stroke Patients With INtracranial Atherosclerosis

Samsung Medical Center80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Stroke Intracranial Atherosclerosis

Interventions

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: During initial admission and 6 months from stroke onset

Secondary Outcomes

Elevated liver function test or muscle enzyme levels

Abnormal laboratory findings of 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

Recurrent stroke/Transient ischemic attack

Time frame: 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

Time frame: 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.

Time frame: During initial admission, an expected average of 1 week

Central Contacts

Oh Young Bang, MD, PhD

CONTACT

+82-2-3410-3599 ohyoungbang@samsung.com

Jong-Won Chung, MD, Msc