Trial of EXenatide in Acute Ischaemic Stroke
TEXAIS
A Multicentre, Randomised Controlled Trial of Exenatide Versus Standard Care in Acute Ischemic Stroke (TEXAIS)
2 other identifiers
interventional
350
3 countries
15
Brief Summary
A multicentre, randomised controlled Trial of Exenatide versus standard care in Acute Ischemic Stroke
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2017
Typical duration for phase_2
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 13, 2017
CompletedFirst Posted
Study publicly available on registry
September 19, 2017
CompletedStudy Start
First participant enrolled
November 23, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 4, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedSeptember 14, 2021
September 1, 2021
3.9 years
July 13, 2017
September 7, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
improved neurological outcome
Treatment with short acting Exenatide (Byetta) in patients with acute ischaemic stroke is hypothesised to improve neurological outcome as measured by ≥8 point improvement in the National Institutes of Health Stroke Scale (NIHSS) stroke disability score (or NIHSS 0-1) at 7 days
7 days
Secondary Outcomes (3)
post stroke hyperglycaemia
90 days
Modified Rankin Scale
90 days
NIHSS
90 days
Study Arms (2)
Active
EXPERIMENTALPatients will receive exenatide injections
Standard Care
NO INTERVENTIONStandard care for stroke as per hospital protocol
Interventions
5μg subcutaneously twice daily for five days, commencing within 9 hours of symptom onset
Eligibility Criteria
You may qualify if:
- Males and females 18 years or older
- Blood glucose level on admission ≥ 4mmol/L
- First trial treatment possible within 9 hours of stroke onset
- Pre-morbid /mRS score of 0-2
You may not qualify if:
- Haemorrhagic stroke
- Poor clinical prognosis /palliation (considered unlikely to survive beyond 14 days post stroke).
- Any known allergy or hypersensitivity to Exenatide
- Females who are pregnant (known or suspected) or currently breastfeeding
- Any past history of pancreatitis or evidence of active pancreatitis
- History of active severe gastrointestinal disease (including but not limited to gastroparesis and dumping syndrome)
- Current chronic kidney disease stage 4 or 5 (creatinine clearance \<30ml/min)
- Current participation in another interventional clinical trial
- Inability to provide consent (participant or person responsible as local laws apply)
- Current use of Exenatide (Byetta®), or other GLP-1 agonist diabetes medication
- Patients considered unlikely to be able to be followed up at 3 months (including but not limited to geographical location of patient at 3 months)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Neuroscience Trials Australialead
- National Health and Medical Research Council, Australiacollaborator
- Monash Universitycollaborator
Study Sites (15)
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, 2010, Australia
Liverpool Hospital
Liverpool, New South Wales, 2170, Australia
Sunshine Coast University Hospital
Birtinya, Queensland, 4575, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
Launceston General Hospital
Launceston, Tasmania, 7250, Australia
Box Hill Hospital
Box Hill, Victoria, 3128, Australia
St Vincent's Hospital Melbourne
Fitzroy, Victoria, 3065, Australia
Austin Hospital
Heidelberg, Victoria, 3084, Australia
Alfred Hospital
Melbourne, Victoria, 3004, Australia
Royal Melbourne Hospital
Parkville, Victoria, 3050, Australia
St John of God Midland Public & Private Hospital
Midland, Western Australia, 6056, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, 6150, Australia
Helsinki University Hospital
Helsinki, 00290, Finland
CDHB Christchurch Hospital
Christchurch, 8140, New Zealand
Related Publications (1)
Bladin CF, Wah Cheung N, Dewey HM, Churilov L, Middleton S, Thijs V, Ekinci E, Levi CR, Lindley R, Donnan GA, Parsons MW, Meretoja A, Tiainen M, Choi PMC, Cordato D, Brown H, Campbell BCV, Davis SM, Cloud G, Grimley R, Lee-Archer M, Ghia D, Sanders L, Markus R, Muller C, Salvaris P, Wu T, Fink J; TEXAIS Investigators. Management of Poststroke Hyperglycemia: Results of the TEXAIS Randomized Clinical Trial. Stroke. 2023 Dec;54(12):2962-2971. doi: 10.1161/STROKEAHA.123.044568. Epub 2023 Nov 27.
PMID: 38011235DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher Bladin
The Florey Institute of Neuroscience & Mental Health Melbourne Brain Centre
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 13, 2017
First Posted
September 19, 2017
Study Start
November 23, 2017
Primary Completion
October 4, 2021
Study Completion
December 31, 2021
Last Updated
September 14, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share