Reducing Intracranial atheroSclErosis With Repatha
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Stenosis
研究概览
简要总结
The purpose of this study will be to understand the underlying mechanism by which PCSK9 inhibition reduces the rate of ischemic stroke seen in the pivotal studies that led to its FDA approval for ASCVD such as ischemic stroke. Those trials (FOURIER and ODYSSEY) enrolled almost 50,000 patients and showed that PCSK9 inhibition therapy is safe and effective. The investigators hypothesize that PCSK9 inhibition lowers the rate of stroke by reducing atherosclerotic plaque, which would be particularly beneficial for patients with intracranial atherosclerosis, who have the highest rate of recurrent stroke of any stroke mechanism.
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
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients, ≥ 18 years of age
- •History of ischemic stroke, defined as an episode of neurological dysfunction caused by focal cerebral, spinal, or retinal infarction (American Heart Association definition).
- •Large vessel atherosclerosis of an intracranial artery in the circle of Willis with 50-99% stenosis by WASID criteria (percent stenosis = (1-[diameter stenosis/diameter normal]) x 100%) on MRA, CTA or DSA
- •----- Eligible arteries: vertebral (V4), basilar, PCA (P1, P2), MCA (M1, M2), tICA, ACA (A1)
- •Current statin use or contraindication to statin
- •Fasting LDL-C ≥ 70 mg/dL or LDL-C ≥ 60 mg/dL if lipoprotein (a) > 30 mg/ dL
排除标准
- •Gadolinium or PCSK9 inhibitor allergy
- •Acute or chronic kidney disease with eGFR<30 ml/min/1.73m2
- •Pacemaker or other MRI contraindications per American College of Radiology guidelines
- •Inability to return for 78 week follow-up clinic visit and vwMRI
研究组 & 干预措施
Intervention Repatha
干预措施: Repatha (Drug)
结局指标
主要结局
Stenosis
时间窗: 1.5 years
Measured on ToF MRA, CE-MRA, T1 Dante
次要结局
- Percent Atheroma Volume(1.5 years)
研究者
David Liebeskind
Principal Investigator
University of California, Los Angeles