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Echoplanar Imaging Thrombolysis Evaluation Trial (EPITHET)

This study is ongoing, but not recruiting participants.

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   

U.S. FDA Resources

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

Further study details as provided by Melbourne Health:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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).

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

Criteria

Inclusion Criteria:

  • Patients who present:
  • 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:

  • Females who are pregnant or breast-feeding,
  • 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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00238537

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

Sponsors and Collaborators
Melbourne Health
Boehringer Ingelheim Pharmaceuticals

Investigators
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)  This link exits the ClinicalTrials.gov site
 

Publications indexed to this study:

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

Keywords provided by Melbourne Health:
Stroke  
Thrombolysis  
MRI  
Echoplanar  
Penumbra  

Study placed in the following topic categories:
Cerebral Infarction
Stroke
Vascular Diseases
Tissue Plasminogen Activator
Central Nervous System Diseases
Brain Diseases
Cerebrovascular Disorders

Additional relevant MeSH terms:
Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 10, 2008




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