Echoplanar Imaging Thrombolysis Evaluation Trial (EPITHET)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00238537|
Recruitment Status : Completed
First Posted : October 13, 2005
Last Update Posted : May 30, 2013
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Drug: Alteplase t-PA||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Echoplanar Imaging Thrombolysis Evaluation Trial (EPITHET) in Acute Stroke|
|Study Start Date :||August 2001|
|Study Completion Date :||April 2007|
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|
|Royal Adelaide Hospital|
|Adelaide, South Australia, Australia, 5000|
|Flinders Medical Center|
|Adelaide, South Australia, Australia, 5042|
|Royal Melbourne Hospital|
|Melbourne, Victoria, Australia, 3050|
|St Vincents Hospital|
|Melbourne, Victoria, Australia, 3065|
|Melbourne, Victoria, Australia, 3081|
|Box Hill Hospital|
|Melbourne, Victoria, Australia, 3128|
|Melbourne, Victoria, Australia, 3144|
|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|