Intraarterial Verapamil for Neuroprotection in Ischemic Stroke
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Number of Participants with Bleeding Complications
研究概览
简要总结
The purpose of this research study is to test an experimental procedure called intra-arterial delivery of verapamil in patients diagnosed with acute ischemic stroke. This study investigates the safety of intra-arterial delivery of verapamil, a drug used to treat vasospasm (spasm of a blood vessel), and how it affects recovery from stroke. Recruitment is limited to patients that have received mechanical thrombectomy as standard of care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Written informed consent
- •18 years of age and over
- •Acute onset focal neurologic deficit consistent with acute ischemic stroke, or computed tomographic scan consistent with acute cerebral ischemia
- •Candidate for mechanical thrombectomy procedure
- •Onset of symptoms less than 8 hours
- •Measurable neurologic deficit (NIHSS ≥4)
- •Willingness to follow up with rehabilitation therapy
- •Anticipated life expectancy of at least 3 months
排除标准
- •Pregnancy or suspected pregnancy (pregnancy test will be done on women of child-bearing potential)
- •Hepatic and/or renal insufficiency (LFT's>3× upper limit of normal; CrCl < 30ml/min)
- •Thrombocytopenia (platelet count <75,000/mm3)
- •History of intolerance to verapamil
- •Previous functional disability (modified Rankin > 1)
- •Severe stroke (NIHSS>22)
- •Stuporous or comatose
- •Unlikely to be available for 90 day follow-up
研究组 & 干预措施
Verapamil 10 mg Treatment Group
Ischemic stroke patients with large penumbra are offered Verapamil treatment following mechanical thrombectomy. The patient will be randomly assigned an intervention group with the specified dose (10 mg) Verapamil.
干预措施: 10 mg Intra-arterial Verapamil (Drug)
Verapamil 20 mg Treatment Group
Ischemic stroke patients with large penumbra are offered Verapamil treatment following mechanical thrombectomy. The patient will be randomly assigned an intervention group with the specified dose (20 mg) Verapamil.
干预措施: 20 mg Intra-arterial Verapamil (Drug)
结局指标
主要结局
Number of Participants with Bleeding Complications
时间窗: 3 months
Bleeding Complications including: symptomatic intracerebral hemorrhage (sICH), and Hemorrhagic Transformation (HT)
Number of Participants with a Serious Adverse Event of Death
时间窗: 3 months
Death
次要结局
- Functional Outcomes(30-days and 90-days)
- Neuroimaging(180 Days, 365 Days)
研究者
Mandy Binning
Director, Global Neurosciences Institute
Global Neurosciences Institute