Register a trial

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03287076




Registration number
NCT03287076
Ethics application status
Date submitted
13/07/2017
Date registered
19/09/2017

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] 0 0
2018-004325-88
Secondary ID [2] 0 0
NTA1127
Universal Trial Number (UTN)
Trial acronym
TEXAIS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Ischemic Stroke 0 0
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Stroke 0 0 0 0
Ischaemic
Neurological 0 0 0 0
Other neurological disorders
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Exenatide Injection

Experimental: Active - Patients will receive exenatide injections

No intervention: Standard Care - Standard care for stroke as per hospital protocol


Treatment: Drugs: Exenatide Injection
5µg subcutaneously twice daily for five days, commencing within 9 hours of symptom onset
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
improved neurological outcome
Timepoint [1] 0 0
7 days
Secondary outcome [1] 0 0
post stroke hyperglycaemia
Timepoint [1] 0 0
90 days
Secondary outcome [2] 0 0
Modified Rankin Scale
Timepoint [2] 0 0
90 days
Secondary outcome [3] 0 0
NIHSS
Timepoint [3] 0 0
90 days

Eligibility
Key inclusion criteria
* Males and females 18 years or older
* Acute Ischaemic Stroke - CT brain exclusion of haemorrhagic stroke
* Blood glucose level on admission = 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
* 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)

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/11/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2021
Actual
Sample size
Target
Accrual to date
Final
350
Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS,VIC,WA
Recruitment hospital [1] 0 0
St Vincent's Hospital Sydney - Darlinghurst
Recruitment hospital [2] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [3] 0 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [4] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [5] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [6] 0 0
Launceston General Hospital - Launceston
Recruitment hospital [7] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [8] 0 0
St Vincent's Hospital Melbourne - Fitzroy
Recruitment hospital [9] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [10] 0 0
Alfred Hospital - Melbourne
Recruitment hospital [11] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [12] 0 0
St John of God Midland Public & Private Hospital - Midland
Recruitment hospital [13] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2170 - Liverpool
Recruitment postcode(s) [3] 0 0
4575 - Birtinya
Recruitment postcode(s) [4] 0 0
4029 - Herston
Recruitment postcode(s) [5] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [6] 0 0
7250 - Launceston
Recruitment postcode(s) [7] 0 0
3128 - Box Hill
Recruitment postcode(s) [8] 0 0
3065 - Fitzroy
Recruitment postcode(s) [9] 0 0
3084 - Heidelberg
Recruitment postcode(s) [10] 0 0
3004 - Melbourne
Recruitment postcode(s) [11] 0 0
3050 - Parkville
Recruitment postcode(s) [12] 0 0
6056 - Midland
Recruitment postcode(s) [13] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
Finland
State/province [1] 0 0
Helsinki
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Other
Name
Neuroscience Trials Australia
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Monash University
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Christopher Bladin
Address 0 0
The Florey Institute of Neuroscience & Mental Health Melbourne Brain Centre
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03287076