Echoplanar Imaging Thrombolysis Evaluation Trial (EPITHET)

This study has been completed.
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by:
Melbourne Health
ClinicalTrials.gov Identifier:
NCT00238537
First received: October 11, 2005
Last updated: May 28, 2013
Last verified: May 2009
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Echoplanar Imaging Thrombolysis Evaluation Trial (EPITHET) in Acute Stroke

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Southern General Hospital
Glasgow, Scotland, United Kingdom
Sponsors and Collaborators
Melbourne Health
Boehringer Ingelheim
Investigators
Study Chair: Stephen M Davis, MD FRCP FRACP Melbourne Health
Study Chair: Geoffrey Donnan, MD FRACP National Stroke Research Institute, Australia
  More Information

Additional Information:
No publications provided by Melbourne Health

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00238537     History of Changes
Other Study ID Numbers: 145671, TGA Trial Number: 1999/271, Enterprise ID: 15314
Study First Received: October 11, 2005
Last Updated: May 28, 2013
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

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Tissue Plasminogen Activator
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents

ClinicalTrials.gov processed this record on July 31, 2014