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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