Mayo Acute Stroke Trial for Enhancing Recovery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Percent of Participants With National Institutes of Health Stroke Scale (NIHSS) Score = 0 or 1 at Day 90
研究概览
简要总结
This study involves treating patients that have suffered an acute ischemic stroke with the medication donepezil (Aricept ®). The hypothesis is that taking donepezil (FDA-approved for the treatment of Alzheimer's Disease) for the first 90 days following a stroke enhances recovery.
详细描述
We hypothesize that donepezil (5 mg per day, titrated up to 10 mg per day as tolerated) will enhance recovery following stroke by improving attention, learning and memory thereby enhancing rehabilitation. The null hypothesis is that the probability of a favorable outcome among post-stroke donepezil users is equal to that observed among similar participants in an existing National Institutes of Neurological Disorders and Stroke (NINDS) resource, the Phase III clinical trial of Tissue Plasminogen Activator (tPA) for acute ischemic stroke. The NINDS tPA stroke trial has been used as historical control data in pilot trials of reperfusion and neuroprotection.
The MASTER trial will be a multicenter, single-arm NINDS Recominant tPA trial-controlled, modified 2-stage adaptive clinical trial set in 2 tertiary care hospitals in the United States. Participants will be men and women with acute (< 24 hours of onset of symptoms) ischemic stroke. A favorable outcome will be defined as National Institutes of Health Stroke Scale (NIHSS) values of 0 or 1 at 90 days post-stroke.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Definite or probable acute ischemic cerebrovascular syndrome (AICS), as defined by Kidwell et al (Stroke. 2003;34:2995-8).
- •Experimental treatment started within 24 hours of onset of symptoms.
- •Age ≥ 18 years.
- •Ability and willingness to return for follow-up visits.
- •Willingness of an available informant who knows the patient well to participate in informant-based questionnaires for the duration of the follow-up period.
- •Living in independent or semi-independent living situation before the stroke.
- •Fluent in English before the stroke.
- •Provides written informed consent.
- •Near visual acuity of at least 20/200 in at least one eye.
- •Auditory acuity of at least having the ability to detect finger rubbing in at least one ear.
排除标准
- •Parkinson's disease or restless leg syndrome.
- •Partial or generalized seizures.
- •No acute decompensated heart failure
- •Routinely requiring daytime supplemental oxygen before the stroke; study participants on continuous positive air pressure (CPAP) for obstructive sleep apnea remain eligible.
- •Gastrointestinal or genitourinary surgery within 1 month of screening.
- •Gastrointestinal bleeding.
- •Syncope or symptomatic bradycardia.
- •Creatinine ≥ 3.5 mg/dL or requiring dialysis.
- •Peptic ulcer disease.
- •Tracheostomy or endotracheal intubation.
- •Taking donepezil or other acetylcholinesterase inhibitor at screening.
研究组 & 干预措施
Donepezil
Participants received treatment with donepezil within 24 hours after the onset of ischemic stroke symptoms. Participants received donepezil 5 mg/day for 30 days, followed by an increase to 10 mg/day for 60 days.
干预措施: Donepezil (Drug)
结局指标
主要结局
Percent of Participants With National Institutes of Health Stroke Scale (NIHSS) Score = 0 or 1 at Day 90
时间窗: 90 days post-stroke
The National Institutes of Health Stroke Scale (NIHSS) is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent's ability to answer questions and perform activities. Ratings for each item are scored with 3 to 5 grades with 0 as normal, and there is an allowance for untestable items. The range of scores is from 0 (normal) to 42 (profound effect of stroke on patient).
次要结局
- Change in Mean National Institutes of Health Stroke Scale (NIHSS) Score at 90 Days Post-stroke(baseline, 90 days post-stroke)
- Change in Mean Barthel Index of Activities of Daily Living Score at 90 Days Post-stroke(baseline, 90 days post-stroke)
- Change in Mean Score on Mini Mental State Exam at 90 Days Post-stroke(baseline, 90 days post-stroke)
- Change in Time to Complete Neuropsychological Trail Making Tests A and B at 90 Days Post-stroke(baseline, 90 days post-stroke)
研究者
James F. Meschia
Principal Investigator
Mayo Clinic