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临床试验/NCT00238537
NCT00238537已完成2 期

Echoplanar Imaging Thrombolysis Evaluation Trial (EPITHET) in Acute Stroke

Melbourne Health27 个研究点 分布在 4 个国家目标入组 100 人开始时间: 2001年8月最近更新:
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

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

申办方类型
Other

研究点 (27)

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