Echoplanar Imaging Thrombolysis Evaluation Trial (EPITHET)

Melbourne Health

Status and phase

Completed

Phase 2

Conditions

Stroke

Treatments

Drug: Alteplase t-PA

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00238537

Enterprise ID: 15314

145671

TGA Trial Number: 1999/271

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.