Overview

Echoplanar Imaging Thrombolysis Evaluation Trial (EPITHET)

Status:
Completed
Trial end date:
2007-04-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Melbourne Health
Collaborator:
Boehringer Ingelheim
Treatments:
Tissue Plasminogen Activator
Criteria
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.