ANZCTR - Registration

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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

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]

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

Condition category

Condition code

Stroke

Ischaemic

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

subcutaneous exenatide 5 microgram twice daily for 5 days

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

control group recieves standard stroke unit care

Control group

Active

Outcomes

Primary outcome [1]

The primary outcome is a greater than 8 point improvement in NIHSS stroke impairment score (or NIHSS 0-1)

Timepoint [1]

7 days post stroke episode

Secondary outcome [1]

frequency of hyperglycaemia (defined as blood glucose is above 7 mmol/L) assessed using a continuous glucose monitor

Timepoint [1]

5 days post stroke

Secondary outcome [2]

Death at day 90

Timepoint [2]

90 days post stroke

Secondary outcome [3]

Modified Rankin Scale (mRS) at day 90

Timepoint [3]

90 days post stroke

Secondary outcome [4]

NIHSS at day 90

Timepoint [4]

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?

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]

Royal Melbourne Hospital - City campus - Parkville

Recruitment hospital [2]

Austin Health - Austin Hospital - Heidelberg

Recruitment hospital [3]

Box Hill Hospital - Box Hill

Recruitment hospital [4]

Fiona Stanley Hospital - Murdoch

Recruitment hospital [5]

Sunshine Coast University Hospital - Birtinya

Recruitment hospital [6]

St Vincent's Hospital (Darlinghurst) - Darlinghurst

Recruitment hospital [7]

Royal Brisbane & Womens Hospital - Herston

Recruitment hospital [8]

The Alfred - Prahran

Recruitment hospital [9]

Liverpool Hospital - Liverpool

Recruitment hospital [10]

Launceston General Hospital - Launceston

Recruitment hospital [11]

Princess Alexandra Hospital - Woolloongabba

Recruitment hospital [12]

St Vincent's Hospital (Melbourne) Ltd - Fitzroy

Recruitment hospital [13]

St John of God Midland Public Hospital - Midland

Recruitment postcode(s) [1]

3050 - Parkville

Recruitment postcode(s) [2]

3084 - Heidelberg

Recruitment postcode(s) [3]

3128 - Box Hill

Recruitment postcode(s) [4]

6150 - Murdoch

Recruitment postcode(s) [5]

4575 - Birtinya

Recruitment postcode(s) [6]

2010 - Darlinghurst

Recruitment postcode(s) [7]

4029 - Herston

Recruitment postcode(s) [8]

3004 - Prahran

Recruitment postcode(s) [9]

2170 - Liverpool

Recruitment postcode(s) [10]

7250 - Launceston

Recruitment postcode(s) [11]

4102 - Woolloongabba

Recruitment postcode(s) [12]

3065 - Fitzroy

Recruitment postcode(s) [13]

6056 - Midland

Recruitment outside Australia

Country [1]

Finland

State/province [1]

Helsinki

Country [2]

New Zealand

State/province [2]

Christchurch

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

NH&MRC

Address [1]

Research Committee Secretariat
NHMRC
GPO Box 1421
Canberra ACT 2601

Country [1]

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]

None

Name [1]

none

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Austin Health HREC

Ethics committee address [1]

Austin Hospital
Office for Research - Austin Health
L8 Harold Stokes Building
145 Studley Road
Heidelberg VIC 3084

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

26/06/2017

Approval date [1]

05/07/2017

Ethics approval number [1]

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

Prof Chris Bladin

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

Phone

+613 90357338

Fax

chris.bladin@unimelb.edu.au

Contact person for public queries

Name

Chris Bladin

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

Phone

+613 90357338

Fax

chris.bladin@unimelb.edu.au

Contact person for scientific queries

Name

Chris Bladin

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

Phone

+613 90357338

Fax

chris.bladin@unimelb.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Source	Title	Year of Publication	DOI
Embase	Management of Poststroke Hyperglycemia: Results of the TEXAIS Randomized Clinical Trial.	2023	https://dx.doi.org/10.1161/STROKEAHA.123.044568

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically