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Sponsors and Collaborators: |
Melbourne Health Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Melbourne Health |
ClinicalTrials.gov Identifier: | NCT00238537 |
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 |
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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 |
Estimated Enrollment: | 100 |
Study Start Date: | August 2001 |
Estimated Study Completion Date: | April 2007 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Study Chair: | Stephen M Davis, MD FRCP FRACP | Melbourne Health |
Study Chair: | Geoffrey Donnan, MD FRACP | National Stroke Research Institute, Australia |
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 |
Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration; Australia: National Health and Medical Research Council |
Stroke Thrombolysis MRI Echoplanar Penumbra |
Cerebral Infarction Stroke Vascular Diseases Tissue Plasminogen Activator |
Central Nervous System Diseases Brain Diseases Cerebrovascular Disorders |
Nervous System Diseases Cardiovascular Diseases |