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Completed

NCT Number: NCT00238537

Echoplanar Imaging Thrombolysis Evaluation Trial (EPITHET)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hunter New England Area Health Service, Newcastle, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Alteplase t-PA

Drug

Primary outcomes

  1. Primary Hypothesis - lesion growth

  2. In patients with penumbra, there will be attenuation of lesion growth (outcome T2 lesion volume - acute DWI volume ) with tPA.

Secondary outcomes

  1. Secondary Hypotheses

  2. In the non-penumbral group, lesion growth will be lower and will not be attenuated by tPA.

  3. Favourable functional outcome (mRS 0-2) will be more likely in patients with penumbra receiving tPA.

  4. 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.

  5. Symptomatic hemorrhagic transformation (sICH) will be predicted by the size of the baseline DWI volume in those patients receiving tPA.

  6. 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.

  7. 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).

Sponsors and collaborators

Lead sponsor

Melbourne Health

Other

Collaborators

  • Boehringer Ingelheim

Registry information

Official study title

Echoplanar Imaging Thrombolysis Evaluation Trial (EPITHET) in Acute Stroke

Important dates

Study start
2001
Study completion
2007
First posted
Oct 13, 2005
Registry last updated
May 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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