Magnesium And Verapamil After Recanalization in Ischemia of the Cerebrum (MAVARIC) in the Kentucky Regional Population: a Clinical and Translational Study.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Number of participants having no symptomatic intracranial hemorrhage
研究概览
简要总结
This is a phase 1, blinded-outcome, randomized, placebo controlled study to investigate the safety and feasibility of super-selective intra-arterial administration of verapamil and magnesium sulfate immediately following successful endovascular thrombectomy as a potential neuroprotective synergistic therapeutic strategy in emergent large vessel occlusion stroke. This trial represents the first time that magnesium sulfate will be evaluated in human subjects as a superselectively administered neuroprotective agent administered in an acute time frame as an adjunct to intra-arterial thrombectomy. Furthermore, it will represent the first trial to evaluate combinational therapy for acute stroke neuroprotection.
详细描述
Participants will be recruited from patients evaluated at University of Kentucky Chandler Hospital for acute ischemic stroke. Participants with impaired capacity may be included, as the pathology to be studied (stroke) may impair their capacity. Initial contact will be made by the sub-investigators approved to obtain consent; all sub-investigators are practitioners who would make contact with potential participants in a clinical manner under standard clinical procedures. All sub-investigators will have access to stroke patients' medical information under normal circumstances. No special outreach is necessary to recruit particular populations. Enrollment goal will be 15 patients in each group.
Participants will not be compensated or provided any incentives for study participation.
The following describes all study procedures and evaluations that are to be done as part of the study.
Visit 1-Baseline (Day 0):
- Obtain consent.
- Medical history taken from medical record, participant and family to determine eligibility based on inclusion/exclusion criteria (Standard of Care)
- Medication history (Standard of Care)
- Physical examination to include vital signs (Standard of Care)
- Pregnancy Testing (Standard of Care)
- NIH Stroke Scale (Standard of Care)
- Verify inclusion/exclusion criteria
- Randomization
- Cerebral angiogram with Endovascular Thrombectomy (Standard of Care)
- Study Drug administration
- Adverse event (AE) collection
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 101 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed and dated informed consent and HIPAA form. Participants with impaired capacity may be included provided a Legally Authorized Representative as recognized by the the State of Kentucky, signs the informed consent.
- •Willingness to comply with all study procedures and availability for the duration of the study.
- •Male or female, aged 18 years or older
- •Suspected acute ischemic stroke based on clinical and radiographic evidence as determined and documented by the Stroke Neurology team at University of Kentucky.
- •Participants must meet criteria for intra-arterial thrombectomy as determined and documented by Interventional Neuroradiology attending physician at University of Kentucky.
- •Participants must have an acute thromboembolus within an intracranial artery in the anterior circulation (internal carotid, anterior cerebral, middle cerebral), which undergoes mechanical thrombectomy.
- •Participant must have a TICI 2B or better revascularization via thrombectomy.
- •For females of reproductive potential a negative pregnancy test at baseline is required.
排除标准
- •Pregnant/lactating women
- •Therapeutic anticoagulation prior to admission as it is a relative contraindication to thrombectomy
- •Participants who undergo intra-arterial thrombectomy for acute stroke, in whom only TICI 0-2A revascularization is obtained.
- •Known allergic reactions to components of Verapamil or magnesium sulfate.
- •Verapamil should not be given to individuals who have a serious heart condition such as:
- •sick sinus syndrome or AV block
- •severe heart failure;
- •fainting do to slow heartbeats
- •certain heart rhythm disorders of the atrium (excluding atrial fibrillation)
- •active congestive heart failure;
- •low blood pressure;
- •a nerve-muscle disorder such as myasthenia gravis or muscular dystrophy.
- •Magnesium Sulfate should not be given to individuals with heart block or heart damage.
研究组 & 干预措施
Verapamil and Magnesium Sulfate
10mg of verapamil in 10 cc of normal saline and 1000mg of magnesium sulfate in 20cc of normal saline will be administered over 20 minutes (1cc/minute) through the microcatheter and into the vessel previously obstructed by clot to the treatment group
干预措施: Verapamil and Magnesium Sulfate (Drug)
Placebo
Control group will receive saline only
干预措施: Placebo (Other)
结局指标
主要结局
Number of participants having no symptomatic intracranial hemorrhage
时间窗: within 48 hours after treatment
Defined as a hemorrhage occurring within 48 hours after study inclusion, temporally related to the intervention, and occurring with worsening neurological status as documented in the clinical exam.
次要结局
- Number of participants who had no systemic side effects from verapamil and magnesium sulfate(within 90 days)
研究者
Justin Fraser
Principal Investigator
University of Kentucky