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Treatment with exenatide in acute ischaemic stroke trial protocol : A prospective, randomised, open label, blinded end-point study of exenatide vs. standard care in post stroke hyperglycaemia
Muller, Claire Cheung, N. Wah Dewey, Helen Churilov, Leonid Middleton, Sandy Thijs, Vincent Ekinci, Elif I. Levi, Chris Lindley, Richard Donnan, Geoffrey
Muller, Claire
Cheung, N. Wah
Dewey, Helen
Churilov, Leonid
Middleton, Sandy
Thijs, Vincent
Ekinci, Elif I.
Levi, Chris
Lindley, Richard
Donnan, Geoffrey
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.
Trial registration: ClinicalTrials.gov/ANZCTR NTA1127
Keywords
acute stroke therapy, incretin, glucagon-like peptide-1 analog, exenatide, hyperglycemia, ischemic stroke, neuroprotection
Date
2018
Type
Journal article
Journal
International Journal of Stroke
Book
Volume
13
Issue
8
Page Range
857-862
Article Number
ACU Department
Nursing Research Institute
Faculty of Health Sciences
Faculty of Health Sciences
Collections
Relation URI
Source URL
Event URL
Open Access Status
License
All rights reserved
File Access
Controlled