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| Sponsors and Collaborators: |
Melbourne Health 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 |
| ChemIDplus related topics: | Alteplase Tissue-type plasminogen activator |
| 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 |
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and 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 | |||||
| Melbourne Health |
| Boehringer Ingelheim Pharmaceuticals |
| Study Chair: | Stephen M Davis, MD FRCP FRACP | Melbourne Health |
| Study Chair: | Geoffrey Donnan, MD FRACP | National Stroke Research Institute, Australia |
More Information
Click here for more information about this study. Echoplanar Imaging Thrombolysis Evaluation Trial (EPITHET) 
  |
| Study ID Numbers: | 145671, TGA Trial Number: 1999/271, Enterprise ID: 15314 |
| 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 |
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