Echoplanar Imaging Thrombolysis Evaluation Trial (EPITHET)

Stroke Clinical Trial

Official title:

Echoplanar Imaging Thrombolysis Evaluation Trial (EPITHET) in Acute Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00238537
• Other study ID #: 145671
• Secondary ID: TGA Trial Number
• Status: Completed
• Phase: Phase 2
• First received: October 11, 2005
• Last updated: May 28, 2013
• Start date: August 2001
• Est. completion date: April 2007

Study information

• Verified date: May 2009
• Source: Melbourne Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationAustralia: National Health and Medical Research Council
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Drug:
• Alteplase t-PA

Locations

Country	Name	City	State
Australia	Flinders Medical Center	Adelaide	South Australia
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Royal Brisbane Hospital	Brisbane	Queensland
Australia	Alfred Hospital	Melbourne	Victoria
Australia	Austin Hospital	Melbourne	Victoria
Australia	Box Hill Hospital	Melbourne	Victoria
Australia	Royal Melbourne Hospital	Melbourne	Victoria
Australia	St Vincents Hospital	Melbourne	Victoria
Australia	Hunter New England Area Health Service	Newcastle	New South Wales
Australia	Royal Perth Hospital	Perth	Western Australia
Belgium	Cliniques Universitaires St Luc	Brussels
New Zealand	Auckland City Hospital	Auckland
New Zealand	Christchurch Hospital	Christchurch
United Kingdom	Southern General Hospital	Glasgow	Scotland

Sponsors (2)

Lead Sponsor	Collaborator
Melbourne Health	Boehringer Ingelheim

Countries where clinical trial is conducted

Australia,  Belgium,  New Zealand,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Hypothesis - lesion growth
Primary	In patients with penumbra, there will be attenuation of lesion growth (outcome T2 lesion volume - acute DWI volume ) with tPA.
Secondary	Secondary Hypotheses
Secondary	In the non-penumbral group, lesion growth will be lower and will not be attenuated by tPA.
Secondary	Favourable functional outcome (mRS 0-2) will be more likely in patients with penumbra receiving tPA.
Secondary	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.
Secondary	Symptomatic hemorrhagic transformation (sICH) will be predicted by the size of the baseline DWI volume in those patients receiving tPA.
Secondary	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.
Secondary	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).

External Links

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