Echoplanar Imaging Thrombolysis Evaluation Trial (EPITHET)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2007 by Melbourne Health.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Melbourne Health
Collaborator:
Boehringer Ingelheim Pharmaceuticals
Information provided by:
Melbourne Health
ClinicalTrials.gov Identifier:
NCT00238537
First received: October 11, 2005
Last updated: March 8, 2007
Last verified: January 2007
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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
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 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
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: | March 8, 2007 |
| 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 May 23, 2013