Status:
COMPLETED
Echoplanar Imaging Thrombolysis Evaluation Trial (EPITHET)
Lead Sponsor:
Melbourne Health
Collaborating Sponsors:
Boehringer Ingelheim
Conditions:
Stroke
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 (t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2001
Trial Type :
INTERVENTIONAL
End Date :
April 1 2007
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00238537
Start Date
August 1 2001
End Date
April 1 2007
Last Update
May 30 2013
Active Locations (14)
Enter a location and click search to find clinical trials sorted by distance.
1
Hunter New England Area Health Service
Newcastle, New South Wales, Australia, 2310
2
Royal Brisbane Hospital
Brisbane, Queensland, Australia, 4072
3
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
4
Flinders Medical Center
Adelaide, South Australia, Australia, 5042