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Clinical Trials/NCT00238537
NCT00238537CompletedPhase 2

Echoplanar Imaging Thrombolysis Evaluation Trial (EPITHET) in Acute Stroke

Melbourne Health27 sites in 4 countries100 target enrollmentStarted: August 2001Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
100
Locations
27
Primary Endpoint
Primary Hypothesis - lesion growth
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Primary Hypothesis - lesion growth

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

Secondary Outcomes

  • 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).

Investigators

Sponsor Class
Other

Study Sites (27)

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