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Sponsors and Collaborators: |
National Stroke Research Institute, Australia Commonwealth Scientific & Industry Research Organisation Brain Research Institute University of Melbourne Melbourne Health |
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Information provided by: | National Stroke Research Institute, Australia |
ClinicalTrials.gov Identifier: | NCT00887328 |
The primary hypothesis being tested in this trial is that ischaemic stroke patients selected with significant penumbral mismatch (measured by MRI criteria) at 3 - 9 hours post onset of stroke will have improved clinical outcomes when given intravenous tissue plasminogen activator (tPA) compared to placebo.
Condition | Intervention | Phase |
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Stroke |
Drug: Tissue Plasminogen Activator Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Extending the Time for Thrombolysis in Emergency Neurological Deficits |
Estimated Enrollment: | 400 |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Tissue Plasminogen Activator
0.9 mg/kg up to a maximum of 90mg, intravenous, 10% as bolus and the remainder over 1 hour
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2: Placebo Comparator |
Drug: Placebo
placebo
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Penumbral imaging** -Using a Tmax ≥ 6 second delay, a perfusion volume to infarct core ratio (PWI) of 1.2, and a perfusion lesion minimum volume of 20 ml.
Exclusion Criteria:
Contact: Sue Bates, BSc(Hons) | +61 3 9496 2754 | sbates@neurotrialsaustralia.com |
Australia, Victoria | |
Royal Melbourne Hospital | |
Melbourne, Victoria, Australia, 3050 |
Principal Investigator: | Geoffrey Donnan, MD FRACP | National Stroke Research Institute, Australia |
Principal Investigator: | Stephen Davis, MD FRACP | University of Melbourne |
Responsible Party: | National Stroke Research Institute ( Professor Geoffrey Donnan ) |
Study ID Numbers: | NTA0901 |
Study First Received: | April 22, 2009 |
Last Updated: | April 22, 2009 |
ClinicalTrials.gov Identifier: | NCT00887328 History of Changes |
Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
Fibrin Modulating Agents Cerebral Infarction Stroke Tissue Plasminogen Activator |
Emergencies Fibrinolytic Agents Cardiovascular Agents Plasminogen |
Fibrin Modulating Agents Disease Attributes Pathologic Processes Molecular Mechanisms of Pharmacological Action Therapeutic Uses Hematologic Agents |
Tissue Plasminogen Activator Emergencies Fibrinolytic Agents Cardiovascular Agents Plasminogen Pharmacologic Actions |