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Trial registered on ANZCTR


Registration number
ACTRN12617000409370
Ethics application status
Approved
Date submitted
8/03/2017
Date registered
21/03/2017
Date last updated
12/04/2023
Date data sharing statement initially provided
12/04/2023
Date results information initially provided
12/04/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Trial of EXenatide in Acute Ischaemic Stroke
Scientific title
A multicentre, randomised controlled Trial of Exenatide versus standard care in Acute Ischemic Stroke (TEXAIS)
Secondary ID [1] 291370 0
Nil known
Universal Trial Number (UTN)
U1111-1193-8786
Trial acronym
TEXAIS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
acute ischaemic stroke 302356 0
Condition category
Condition code
Stroke 301942 301942 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
subcutaneous exenatide 5 microgram twice daily for 5 days
Intervention code [1] 297392 0
Treatment: Drugs
Comparator / control treatment
control group recieves standard stroke unit care
Control group
Active

Outcomes
Primary outcome [1] 301363 0
The primary outcome is a greater than 8 point improvement in NIHSS stroke impairment score (or NIHSS 0-1)
Timepoint [1] 301363 0
7 days post stroke episode
Secondary outcome [1] 332424 0
frequency of hyperglycaemia (defined as blood glucose is above 7 mmol/L) assessed using a continuous glucose monitor
Timepoint [1] 332424 0
5 days post stroke
Secondary outcome [2] 332426 0
Death at day 90
Timepoint [2] 332426 0
90 days post stroke
Secondary outcome [3] 332427 0
Modified Rankin Scale (mRS) at day 90
Timepoint [3] 332427 0
90 days post stroke
Secondary outcome [4] 332428 0
NIHSS at day 90
Timepoint [4] 332428 0
90 days post stroke

Eligibility
Key inclusion criteria
Males and females 18 years or older
Acute Ischaemic stroke – (CT to exclude haemorrhagic stroke)
Blood sugar level on admission greater than or equal to 4mmol/L
First trial treatment possible within 9 hours of stroke onset
Pre-morbid mRS score of 0-2
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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
Past history of 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 investigational drug or interventional trial.
*Inability to provide consent (participant or person responsible as local laws apply)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
permuted blocks of various sizes
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
528 (randomisation ratio 1:1)
Under two-tailed alpha=0.05, a total sample of 528 patients (equally distributed between treatment and control groups as 264:264) will yield 80% power to observe a between-group difference in proportions of patients with favourable outcome of 13% or higher (from 35% in the control group to 48% in the treatment group).
Adaptive sample size re-estimation according to the promising zone methodology (Mehta and Pocock) will be conducted at n= 320 patients with an absolute pre-determined upper limit of 650 patients.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/07/2017
Actual
23/11/2017
Date of last participant enrolment
Anticipated
31/12/2019
Actual
1/07/2021
Date of last data collection
Anticipated
31/12/2019
Actual
10/03/2022
Sample size
Target
528
Accrual to date
Final
350
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 9789 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [2] 9790 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [3] 9791 0
Box Hill Hospital - Box Hill
Recruitment hospital [4] 9792 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [5] 9793 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [6] 9794 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [7] 9795 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [8] 9796 0
The Alfred - Prahran
Recruitment hospital [9] 9797 0
Liverpool Hospital - Liverpool
Recruitment hospital [10] 24502 0
Launceston General Hospital - Launceston
Recruitment hospital [11] 24503 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [12] 24504 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [13] 24505 0
St John of God Midland Public Hospital - Midland
Recruitment postcode(s) [1] 18571 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 18574 0
2170 - Liverpool
Recruitment postcode(s) [3] 18573 0
3004 - Prahran
Recruitment postcode(s) [4] 18566 0
3050 - Parkville
Recruitment postcode(s) [5] 40093 0
3065 - Fitzroy
Recruitment postcode(s) [6] 18567 0
3084 - Heidelberg
Recruitment postcode(s) [7] 18568 0
3128 - Box Hill
Recruitment postcode(s) [8] 18572 0
4029 - Herston
Recruitment postcode(s) [9] 40092 0
4102 - Woolloongabba
Recruitment postcode(s) [10] 18570 0
4575 - Birtinya
Recruitment postcode(s) [11] 40094 0
6056 - Midland
Recruitment postcode(s) [12] 18569 0
6150 - Murdoch
Recruitment postcode(s) [13] 40091 0
7250 - Launceston
Recruitment outside Australia
Country [1] 25393 0
Finland
State/province [1] 25393 0
Helsinki
Country [2] 25394 0
New Zealand
State/province [2] 25394 0
Christchurch

Funding & Sponsors
Funding source category [1] 295842 0
Government body
Name [1] 295842 0
NH&MRC
Country [1] 295842 0
Australia
Primary sponsor type
University
Name
Monash University Eastern Health Clinical School.
Address
Monash University
Eastern Health Clinical School, Monash University
Florey Institute of Neuroscience and Mental Health
245 Burgundy Street
Heidelberg VIC 3084
Australia
Country
Australia
Secondary sponsor category [1] 294693 0
None
Name [1] 294693 0
none
Address [1] 294693 0
Country [1] 294693 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297124 0
Austin Health HREC
Ethics committee address [1] 297124 0
Austin Hospital
Office for Research - Austin Health
L8 Harold Stokes Building
145 Studley Road
Heidelberg VIC 3084
Ethics committee country [1] 297124 0
Australia
Date submitted for ethics approval [1] 297124 0
26/06/2017
Approval date [1] 297124 0
05/07/2017
Ethics approval number [1] 297124 0
HREC/17/Austin/113

Summary
Brief summary
Elevated blood glucose levels are common in many acute diseases, resulting in worse clinical outcomes for patients. Hyperglycaemia in acute ischaemic stroke (post-stroke hyperglycaemia [PSH]) occurs in up to 50% patients, reduces the efficacy of stroke thrombolysis with increased risk of haemorrhage, increases infarct size, and results in worse clinical outcomes and death. Insulin-based therapies have not proved beneficial in treating PSH: they are difficult to implement and maintain, cause frequent hypoglycaemia, may cause increased infarct size, and have not shown to reduce mortality or improve clinical outcomes. An alternative, simple to use treatment for PSH may therefore have a significant impact not only for acute stroke care, but in other acute diseases.
Exenatide is a commonly used diabetes drug (a synthetic glucagon-like peptide-1 receptor agonist) that amongst its effects increases insulin secretion. Importantly, this action is glucose dependent - as blood glucose levels decrease, its stimulatory effect on insulin secretion subsides, with a very low risk of hypoglycaemia. A previous pilot study of 17 consecutive, unselected patients (i.e. regardless of their admission glucose level) with acute ischaemic stroke compared subcutaneous Exenatide 5 micrograms for 5 days versus routine standard care. Blood glucose levels remained consistently lower (and less variable) in the treatment group, most noticeably in those stroke patients with known diabetes. Exenatide was safe and well tolerated by all patients, with no symptomatic hypoglycaemia.
TEXAIS is a 3 year Phase 2, multi-centre, prospective, randomised, open label, blinded end-point trial comparing subcutaneous Exenatide (5 micrograms) to Standard of Care. The number of patients to be recruited is 528 patients (264 in each arm) with a primary end point of early neurological improvement at 7 days, and secondary end points of recovery at 90 days. Continuous glucose monitors will track the intra-day dynamic variability of glucose in acute stroke in all trial patients (treatment and standard care).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 73058 0
Prof Chris Bladin
Address 73058 0
Monash University
Eastern Health Clinical School, Monash University
Florey Institute of Neuroscience and Mental Health
245 Burgundy Street
Heidelberg VIC 3084
Australia
Country 73058 0
Australia
Phone 73058 0
+613 90357338
Fax 73058 0
Email 73058 0
chris.bladin@unimelb.edu.au
Contact person for public queries
Name 73059 0
Prof Chris Bladin
Address 73059 0
Monash University
Eastern Health Clinical School, Monash University
Florey Institute of Neuroscience and Mental Health
245 Burgundy Street
Heidelberg VIC 3084
Australia
Country 73059 0
Australia
Phone 73059 0
+613 90357338
Fax 73059 0
Email 73059 0
chris.bladin@unimelb.edu.au
Contact person for scientific queries
Name 73060 0
Prof Chris Bladin
Address 73060 0
Monash University
Eastern Health Clinical School, Monash University
Florey Institute of Neuroscience and Mental Health
245 Burgundy Street
Heidelberg VIC 3084
Australia
Country 73060 0
Australia
Phone 73060 0
+613 90357338
Fax 73060 0
Email 73060 0
chris.bladin@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseManagement of Poststroke Hyperglycemia: Results of the TEXAIS Randomized Clinical Trial.2023https://dx.doi.org/10.1161/STROKEAHA.123.044568
N.B. These documents automatically identified may not have been verified by the study sponsor.