Echoplanar Imaging Thrombolysis Evaluation Trial (EPITHET) - Full Text View

Sponsor:	Melbourne Health
Collaborator:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Melbourne Health
ClinicalTrials.gov Identifier:	NCT00238537

Purpose

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.

Condition	Intervention	Phase
Stroke	Drug: Alteplase t-PA	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Echoplanar Imaging Thrombolysis Evaluation Trial (EPITHET) in Acute Stroke

Resource links provided by NLM:

Drug Information available for: Alteplase Tissue-type plasminogen activator

U.S. FDA Resources

Further study details as provided by Melbourne Health:

Primary Outcome Measures:

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 Outcome Measures:

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).

Estimated Enrollment:	100
Study Start Date:	August 2001
Estimated Study Completion Date:	April 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00238537

Locations

Australia, New South Wales
Hunter New England Area Health Service
Newcastle, New South Wales, Australia, 2310
Australia, Queensland
Royal Brisbane Hospital
Brisbane, Queensland, Australia, 4072
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Flinders Medical Center
Adelaide, South Australia, Australia, 5042
Australia, Victoria
Royal Melbourne Hospital
Melbourne, Victoria, Australia, 3050
Austin Hospital
Melbourne, Victoria, Australia, 3081
Box Hill Hospital
Melbourne, Victoria, Australia, 3128
St Vincents Hospital
Melbourne, Victoria, Australia, 3065
Alfred Hospital
Melbourne, Victoria, Australia, 3144
Australia, Western Australia
Royal Perth Hospital
Perth, Western Australia, Australia, 6001
Belgium
Cliniques Universitaires St Luc
Brussels, Belgium, B-1200
New Zealand
Auckland City Hospital
Auckland, New Zealand, 92024
Christchurch Hospital
Christchurch, New Zealand, 4710
United Kingdom, Scotland
Southern General Hospital
Glasgow, Scotland, United Kingdom

Sponsors and Collaborators

Melbourne Health

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:	Stephen M Davis, MD FRCP FRACP	Melbourne Health
Study Chair:	Geoffrey Donnan, MD FRACP	National Stroke Research Institute, Australia

More Information

Additional Information:

Click here for more information about this study. Echoplanar Imaging Thrombolysis Evaluation Trial (EPITHET) This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

No publications provided by Melbourne Health

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Davis SM, Donnan GA, Parsons MW, Levi C, Butcher KS, Peeters A, Barber PA, Bladin C, De Silva DA, Byrnes G, Chalk JB, Fink JN, Kimber TE, Schultz D, Hand PJ, Frayne J, Hankey G, Muir K, Gerraty R, Tress BM, Desmond PM; EPITHET investigators. Effects of alteplase beyond 3 h after stroke in the Echoplanar Imaging Thrombolytic Evaluation Trial (EPITHET): a placebo-controlled randomised trial. Lancet Neurol. 2008 Apr;7(4):299-309. Epub 2008 Feb 28.

Study ID Numbers:	145671, TGA Trial Number: 1999/271, Enterprise ID: 15314
Study First Received:	October 11, 2005
Last Updated:	March 8, 2007
ClinicalTrials.gov Identifier:	NCT00238537 History of Changes
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration; Australia: National Health and Medical Research Council

Keywords provided by Melbourne Health:

Stroke
Thrombolysis
MRI
Echoplanar
Penumbra

Additional relevant MeSH terms:

Cerebral Infarction
Nervous System Diseases
Stroke
Vascular Diseases
Brain Ischemia

Central Nervous System Diseases
Cardiovascular Diseases
Brain Infarction
Brain Diseases
Cerebrovascular Disorders

ClinicalTrials.gov processed this record on November 27, 2009