Title
Echoplanar Imaging Thrombolysis Evaluation Trial (EPITHET)
Echoplanar Imaging Thrombolysis Evaluation Trial (EPITHET) in Acute Stroke
Phase
Phase 2Lead Sponsor
Melbourne HealthStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
StrokeIntervention/Treatment
alteplase ...Study Participants
100To 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.
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.