Combinating Fingolimod With Endovascular Treatment in Acute Ischemic Stroke
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- the grade of collateral circulation
研究概览
简要总结
Proof-of concept clinical trials have indicated that the sphingosine-1-phosphate receptor modulator fingolimod may be efficacious in attenuating brain inflammation and improving clinical outcomes in patients with acute ischemic stroke as a single therapy beyond 4.5 hours of disease onset, or in combination with alteplase within 4.5 hours of disease onset. This study aim to determine whether fingolimod enhance the action of endovascular treatment for acute ischemic stroke
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presenting with anterior circulation acute ischaemic stroke who are eligible for mechanical thrombectomy commenced within 6-24 hours of stroke onset.
- •Patient, family member or legally responsible person depending on local ethics requirements has given informed consent.
- •Patient's age is 18-80 years.
- •Arterial occlusion on internal carotid artery proximal or middle cerebral artery
- •Imaging inclusion criteria: infarct core volume between 15-70 mL
排除标准
- •Pre-existing neurologic disability (a score greater than 2 on the mRS).
- •Swallowing difficulties that would prevent administration of oral fingolimod.
- •Patients with any history of bradyarrhythmia, atrioventricular block or current use of beta-blockers or verapamil.
- •Patients with serious acute or chronic infection, or hepatic injury
- •Concomitant use of antineoplastic, immunosuppressive or immune modulating therapies.
- •Macular edema.
研究组 & 干预措施
endovascular treatment with fingolimod
干预措施: Fingolimod (Drug)
结局指标
主要结局
the grade of collateral circulation
时间窗: Baseline (before endovascular treatment)
Multiphasic contrast-enhanced CT collateral grades with six-point pial arterial filling ordinary score as established at the University of Calgary
次要结局
未报告次要终点
研究者
Ning Wang, MD., PhD.
Director of Neurology department
First Affiliated Hospital of Fujian Medical University