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Title: Treatment with exenatide in acute ischemic stroke trial protocol: A prospective, randomized, open label, blinded end-point study of exenatide vs. standard care in post stroke hyperglycemia.
Austin Authors: Muller, Claire;Cheung, N Wah;Dewey, Helen;Churilov, Leonid ;Middleton, Sandy;Thijs, Vincent N ;Ekinci, Elif I ;Levi, Chris;Lindley, Richard;Donnan, Geoffrey;Parsons, Mark;Bladin, Christopher
Affiliation: Monash University Eastern Health Clinical School, Melbourne, Victoria, Australia
The Royal Brisbane and Women's Hospital, Brisbane, QLD, Australia
Centre for Diabetes and Endocrinology Research Westmead, Westmead Hospital & University of Sydney, NSW, Australia
Faculty of Medicine, Nursing and Health Sciences, Monash University, Victoria, Australia
The Florey Institute of Neuroscience and Mental Health
Nursing Research Institute, St Vincent's & Health Australia (Sydney)
Australian Catholic University, St Vincent's Hospital, NSW, Australia
Medicine (University of Melbourne)
Priority Research Centre for Stroke and Brain Injury, Hunter Medical Research Institute, University of Newcastle, John Hunter Hospital, Newcastle, NSW, Australia
Department of Neurology, John Hunter Hospital, Newcastle, NSW, Australia
Sydney Medical School, Westmead Hospital Clinical School (C24) Sydney, The University of Sydney, NSW, Australia
George Institute for Global Health, Sydney, NSW, Australia
Issue Date: 1-Jan-2018
Date: 2018-01-01
Publication information: International Journal of Stroke 2018: 1747493018784436
Abstract: Rationale Post-stroke hyperglycemia occurs in up to 50% of patients presenting with acute ischemic stroke. It reduces the efficacy of thrombolysis, increases infarct size, and worsens clinical outcomes. Insulin-based therapies have generally not been beneficial in treating post-stroke hyperglycemia as they are difficult to implement, may cause hypoglycaemia, possibly increase mortality and worsen clinical outcomes. Exenatide may be a safer, simpler, and more effective alternative to insulin in acute ischemic stroke. Design TEXAIS is a three year, Phase 2, multi-center, prospective, randomized, open label, blinded end-point trial comparing exenatide to standard of care. It aims to recruit 528 patients with a primary end point of major neurological improvement at 7 days defined as a ≥8-point improvement in NIHSS score, or NIHSS 0-1. Secondary outcomes of hyper- and hypoglycaemia at 5 days and NIHSS and mRS at 90 days will be measured. The treatment arm will receive exenatide 5 µg subcutaneously twice daily. The control arm will receive standard stroke unit care. Continuous glucose monitors will track the dynamic variability of glucose. Conclusion TEXAIS aims to show that exenatide is safe and effective in the treatment of post-stroke hyperglycemia. It has been designed to be highly generalizable with an ability to enroll a large percentage of patients with acute ischemic stroke, regardless of admission blood glucose level, diabetes status, or stroke severity, with very low risk of hypoglycemia. NTA1127.
DOI: 10.1177/1747493018784436
ORCID: 0000-0002-9250-936X
Journal: International Journal of Stroke
PubMed URL: 30019627
Type: Journal Article
Subjects: Acute Stroke therapy
glucagon-like peptide-1 analog
Ischaemic Stroke
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