Echoplanar Imaging Thrombolysis Evaluation Trial (EPITHET)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Echoplanar Imaging Thrombolysis Evaluation Trial (EPITHET) in Acute Stroke|
- 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 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).
|Study Start Date:||August 2001|
|Estimated Study Completion Date:||April 2007|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00238537
|Australia, New South Wales|
|Hunter New England Area Health Service|
|Newcastle, New South Wales, Australia, 2310|
|Royal Brisbane Hospital|
|Brisbane, Queensland, Australia, 4072|
|Australia, South Australia|
|Flinders Medical Center|
|Adelaide, South Australia, Australia, 5042|
|Royal Adelaide Hospital|
|Adelaide, South Australia, Australia, 5000|
|Melbourne, Victoria, Australia, 3144|
|Royal Melbourne Hospital|
|Melbourne, Victoria, Australia, 3050|
|Melbourne, Victoria, Australia, 3081|
|Box Hill Hospital|
|Melbourne, Victoria, Australia, 3128|
|St Vincents Hospital|
|Melbourne, Victoria, Australia, 3065|
|Australia, Western Australia|
|Royal Perth Hospital|
|Perth, Western Australia, Australia, 6001|
|Cliniques Universitaires St Luc|
|Brussels, Belgium, B-1200|
|Auckland City Hospital|
|Auckland, New Zealand, 92024|
|Christchurch, New Zealand, 4710|
|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|