Intensive Statin Treatment in Acute Ischemic Stroke Patients With INtracranial Atherosclerosis - High-Resolution Magnetic Resonance Imaging Study (STAMINA-MRI Study)
试验速览
- 阶段
- 4 期
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Changes in vascular remodeling before and after the statin treatment
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Changes in vascular remodeling before and after the statin treatment
时间窗: 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
次要结局
- Recurrent stroke/Transient ischemic attack(Admission to study completion date, an expected average of 1 year)
- Elevated liver function test or muscle enzyme levels(During initial admission, an expected average of 1 week, and 1 and 3 month after discharge)
- All causes of death(Admission to study completion date, an expected average of 1 year)
- Exploration of biomarkers(During initial admission, an expected average of 1 week)