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

October 11, 2005
May 28, 2013
August 2001
Not Provided
  • Primary Hypothesis - lesion growth
  • In patients with penumbra, there will be attenuation of lesion growth (outcome T2 lesion volume - acute DWI volume ) with tPA.
Change in the size of the ischemic lesion between baseline and follow-up studies, as visualized with diffusion-weighted imaging (DWI).
Complete list of historical versions of study NCT00238537 on ClinicalTrials.gov Archive Site
  • 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).
  • - Reperfusion defined as change between acute PWI volume(3-6 hours) and subacute PWI volume (3-5 days);
  • - symptomatic hemorrhagic transformation at day 3, as assessed by MRI;
  • - infarct volume, as measured with T2-weighted MRI;
  • - degree of recanalization of the MCA;
  • - proportion of patients making an 11-point improvement in their NIHSS score;
  • - percentage of patients reaching an MRS score of 0 - 2 or
  • - Barthel Index (BI) score >= 85.
Not Provided
Not Provided
 
Echoplanar Imaging Thrombolysis Evaluation Trial (EPITHET)
Echoplanar Imaging Thrombolysis Evaluation Trial (EPITHET) in Acute Stroke

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Stroke
Drug: Alteplase t-PA
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
April 2007
Not Provided

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Belgium,   New Zealand,   United Kingdom
 
NCT00238537
145671, TGA Trial Number: 1999/271, Enterprise ID: 15314
Not Provided
Not Provided
Melbourne Health
Boehringer Ingelheim
Study Chair: Stephen M Davis, MD FRCP FRACP Melbourne Health
Study Chair: Geoffrey Donnan, MD FRACP National Stroke Research Institute, Australia
Melbourne Health
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP