Echoplanar Imaging Thrombolysis Evaluation Trial (EPITHET)
NCT ID: NCT00238537
Last Updated: 2013-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
100 participants
INTERVENTIONAL
2001-08-31
2007-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Alteplase t-PA
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Melbourne Health
OTHER
Principal Investigators
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Stephen M Davis, MD FRCP FRACP
Role: STUDY_CHAIR
Melbourne Health
Geoffrey Donnan, MD FRACP
Role: STUDY_CHAIR
National Stroke Research Institute, Australia
Locations
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Hunter New England Area Health Service
Newcastle, New South Wales, Australia
Royal Brisbane Hospital
Brisbane, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Flinders Medical Center
Adelaide, South Australia, Australia
Royal Melbourne Hospital
Melbourne, Victoria, Australia
St Vincents Hospital
Melbourne, Victoria, Australia
Austin Hospital
Melbourne, Victoria, Australia
Box Hill Hospital
Melbourne, Victoria, Australia
Alfred Hospital
Melbourne, Victoria, Australia
Royal Perth Hospital
Perth, Western Australia, Australia
Cliniques Universitaires St Luc
Brussels, , Belgium
Auckland City Hospital
Auckland, , New Zealand
Christchurch Hospital
Christchurch, , New Zealand
Southern General Hospital
Glasgow, Scotland, United Kingdom
Countries
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References
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Ogata T, Christensen S, Nagakane Y, Ma H, Campbell BC, Churilov L, Lansberg MG, Straka M, De Silva DA, Mlynash M, Bammer R, Olivot JM, Desmond PM, Albers GW, Davis SM, Donnan GA; EPITHET and DEFUSE Investigators. The effects of alteplase 3 to 6 hours after stroke in the EPITHET-DEFUSE combined dataset: post hoc case-control study. Stroke. 2013 Jan;44(1):87-93. doi: 10.1161/STROKEAHA.112.668301. Epub 2012 Dec 18.
Mlynash M, Lansberg MG, De Silva DA, Lee J, Christensen S, Straka M, Campbell BC, Bammer R, Olivot JM, Desmond P, Donnan GA, Davis SM, Albers GW; DEFUSE-EPITHET Investigators. Refining the definition of the malignant profile: insights from the DEFUSE-EPITHET pooled data set. Stroke. 2011 May;42(5):1270-5. doi: 10.1161/STROKEAHA.110.601609. Epub 2011 Apr 7.
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. doi: 10.1016/S1474-4422(08)70044-9. Epub 2008 Feb 28.
Other Identifiers
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TGA Trial Number: 1999/271
Identifier Type: -
Identifier Source: secondary_id
Enterprise ID: 15314
Identifier Type: -
Identifier Source: secondary_id
145671
Identifier Type: -
Identifier Source: org_study_id
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