NCT00238537已完成2 期
Echoplanar Imaging Thrombolysis Evaluation Trial (EPITHET) in Acute Stroke
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 27
- 主要终点
- Primary Hypothesis - lesion growth
研究概览
简要总结
To determine whether the extent of the ischemic penumbra apparent on perfusion-diffusion MRI can be used to identify patients who would respond positively and safely to tissue plasminogen activator (tPA) beyond 3 hours post-stroke.
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
- Double
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
- •Patients who present:
- •with acute hemispheric stroke within 3-6 hours of onset,
- •have at least moderate limb weakness,
- •a National Institute of Health Stroke Scale (NIHSS) score > 4,
- •had a pre-stroke modified Rankin Scale (MRS) score of 0 - 2
- •and who are able to undergo CT and MRI, are eligible for this study.
排除标准
- •Females who are pregnant or breast-feeding,
- •persons who have CT-verified hemorrhagic stroke, major ischemia ( > 33% of the middle cerebral artery (MCA) territory infarcted), subarachnoid hemorrhage, arteriovenous malformation, aneurysm, intracranial neoplasm that is terminal or poses a risk of hemorrhage ,
- •are comatose or severely obtunded with fixed eye deviation and complete hemiplegia,
- •have had another stroke within the past 6 weeks,
- •have had a seizure prior to the administration of the study drug,
- •have active peptic ulceration, bleeding diatheses, previous intracerebral hemorrhage,
- •blood pressure > 185/110,
- •major surgery or trauma within the past 30 days, or any other contraindications to tPA
- •have a presumed septic embolus or a myocardial infarction within the past 30 days
- •blood glucose values are < 2.8 or > 22.0 mmol/L,
- •pacemakers, aneurysm clips, implanted devices, claustrophobia, or any other contraindications to MRI,
- •decreased consciousness,
- •rapid clinical improvement,
- •confounding neurological condition (e.g. dementia),
- •any other life-threatening illness, or who are participating in another clinical trial, will be excluded from this study.
结局指标
主要结局
Primary Hypothesis - lesion growth
In patients with penumbra, there will be attenuation of lesion growth (outcome T2 lesion volume - acute DWI volume ) with tPA.
次要结局
- Secondary Hypotheses
- In the non-penumbral group, lesion growth will be lower and will not be attenuated by tPA.
- Favourable functional outcome (mRS 0-2) will be more likely in patients with penumbra receiving tPA.
- That the proportion of patients achieving good neurological outcome (an 8 point improvement in NIH-SS or outcome NIH-SS of 0, 1) will be greater in those patients with a penumbra receiving tPA.
- Symptomatic hemorrhagic transformation (sICH) will be predicted by the size of the baseline DWI volume in those patients receiving tPA.
- Reperfusion (greater than 90% PWI lesion reduction, or recanalisation on MRA, between the acute and sub-acute interval), will be increased (in patients with penumbra) receiving tPA.
- In patients with malignant mismatch (Definition DWI 100ml or more and / or PWI 100ml or more) there will be unfavourable clinical outcome (even if there is attenuation of growth).
研究者
研究点 (27)
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