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Trial of EXenatide in Acute Ischaemic Stroke (TEXAIS)

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ClinicalTrials.gov Identifier: NCT03287076
Recruitment Status : Recruiting
First Posted : September 19, 2017
Last Update Posted : August 22, 2019
Sponsor:
Collaborators:
National Health and Medical Research Council, Australia
Monash University
Information provided by (Responsible Party):
Neuroscience Trials Australia

Brief Summary:

Overview: Elevated blood glucose levels are common in many acute diseases, resulting in worse clinical outcomes. 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 do not 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.

Pilot data: Exenatide is a commonly used diabetes drug (a synthetic glucagon- like peptide-1 receptor agonist) that 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 small randomised pilot study of 17 consecutive, unselected patients (ie. regardless of their admission glucose level) with acute ischaemic stroke compared subcutaneous exenatide 5μg for 5 days with routine standard of care. Overall, blood glucose levels remained consistently lower (and less variable) in the exenatide group, and most noticeably in those stroke patients with known diabetes. Exenatide was safe and well tolerated by all patients, with no symptomatic hypoglycaemia.

Trial design: TEXAIS is a 3 year Phase 2, multi centre, prospective, randomised, open label, blinded end-point (PROBE) trial comparing Exenatide to Standard of Care. The sample size is 528 patients (264 in each arm).

Intervention: Treatment arm will receive Exenatide (Byetta) 5μg subcutaneously twice daily for five days, commencing within 9 hours of symptom onset. Stroke onset time for wake-up strokes is taken as mid-point between going to bed, and waking up. Antiemetic therapy (metoclopramide or ondansetron) will be commenced with the first dose of Exenatide. In patients receiving tPA, Exenatide will be given alongside, or as soon as possible, following tPA administration (within 60 minutes). Diabetic patients already on oral agents and/or insulin may continue these (as per standard practice) in addition to Exenatide. Continuous glucose monitors (CGMs) will track the intra-day dynamic variability of glucose in acute stroke.

Translation: TEXAIS is a simple, practical, study that can enrol all patients with ischaemic stroke, regardless of admission blood glucose level, regardless of stroke severity, with no target glucose level, and with low risk of hypoglycaemia.


Condition or disease Intervention/treatment Phase
Acute Ischemic Stroke Drug: Exenatide Injection Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 528 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicentre, Randomised Controlled Trial of Exenatide Versus Standard Care in Acute Ischemic Stroke (TEXAIS)
Actual Study Start Date : November 23, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Exenatide

Arm Intervention/treatment
Experimental: active
Patients will receive exenatide injections
Drug: Exenatide Injection
5μg subcutaneously twice daily for five days, commencing within 9 hours of symptom onset
Other Name: Byetta

No Intervention: standard care/no intervention
standard care for stroke as per hospital protocol



Primary Outcome Measures :
  1. improved neurological outcome [ Time Frame: 7 days ]
    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


Secondary Outcome Measures :
  1. post stroke hyperglycaemia [ Time Frame: 90 days ]
    reduce the occurrence of post stroke hyperglycaemia (>7mmol/l).

  2. Modified Rankin Scale [ Time Frame: 90 days ]
    improve Modified Rankin Scale (mRS) at 90 days

  3. NIHSS [ Time Frame: 90 days ]
    improve NIHSS at 90 days



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03287076


Contacts
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Contact: Christopher Bladin +61 3 9035 7339 chris.bladin@unimelb.edu.au
Contact: Maddalena Borromeo +61 408 491 663 maddalena.borromeo@florey.edu.au

Locations
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Australia, New South Wales
St Vincent's Hospital Sydney Recruiting
Darlinghurst, New South Wales, Australia, 2010
Contact: Simeon Dale    +61 2 8382 4027    simeon.dale@acu.edu.au   
Principal Investigator: Sandy Middleton         
Liverpool Hospital Recruiting
Liverpool, New South Wales, Australia, 2170
Contact: Cheryl Qi Cheng    +61 2 8738 7170    Qi.Cheng@health.nsw.gov.au   
Principal Investigator: Dennis Cordato         
Australia, Queensland
Sunshine Coast University Hospital Recruiting
Birtinya, Queensland, Australia, 4575
Contact: Karen Simmons    +61 7 5202 3155    Karen.Simmons@health.qld.gov.au   
Principal Investigator: Rohan Grimley         
Royal Brisbane and Women's Hospital Recruiting
Herston, Queensland, Australia, 4029
Contact: Claire Muller    +61 7 3646 8111    claire.muller@health.qld.gov.au   
Principal Investigator: Claire Muller         
Princess Alexandra Hospital Recruiting
Woolloongabba, Queensland, Australia, 4102
Contact: Carol Bendall    +61 7 3176 5169    SRUPAH@health.qld.gov.au   
Principal Investigator: Darshan Shah         
Australia, Tasmania
Launceston General Hospital Not yet recruiting
Launceston, Tasmania, Australia, 7250
Contact: Monika O'Connor    +61 3 6777 6583    monika.oconnor@ths.tas.gov.au   
Principal Investigator: Matthew Lee-Archer         
Australia, Victoria
Box Hill Hospital Recruiting
Box Hill, Victoria, Australia, 3128
Contact: Grace Thomas    +61 3 9094 9541    Grace.Thomas@monash.edu   
Principal Investigator: Helen Dewey         
St Vincent's Hospital Melbourne Recruiting
Fitzroy, Victoria, Australia, 3065
Contact: Iveta Krivonos    +61 3 9231 3365    iveta.krivonos@svha.org.au   
Principal Investigator: Lauren Sanders         
Austin Hospital Recruiting
Heidelberg, Victoria, Australia, 3084
Contact: Dennis Young    +61 3 9496 4953    dennis.Young@austin.org.au   
Principal Investigator: Vincent Thijs         
Alfred Hospital Recruiting
Melbourne, Victoria, Australia, 3004
Contact: Andrea Moore    +61 3 9076 3581    andrea.moore@alfred.org.au   
Principal Investigator: Geoffrey Cloud         
Royal Melbourne Hospital Recruiting
Parkville, Victoria, Australia, 3050
Contact: David Jackson    +61 3 9342 7598    david.jackson@mh.org.au   
Principal Investigator: Stephen Davis         
Australia, Western Australia
St John of God Midland Public & Private Hospital Not yet recruiting
Midland, Western Australia, Australia, 6056
Contact: Lynda Southwell    +61 8 9462 4170    Lynda.Southwell@sjog.org.au   
Principal Investigator: Patrick Salvaris         
Fiona Stanley Hospital Recruiting
Murdoch, Western Australia, Australia, 6150
Contact: Nicole O'Loughlin    +61 8 6152 4874    FSH.StrokeClinicalTrials@health.wa.gov.au   
Principal Investigator: Darshan Ghia         
Finland
Helsinki University Hospital Recruiting
Helsinki, Finland, 00290
Contact: Saija Eirola    +358 9 47172662    Saija.Eirola@hus.fi   
Principal Investigator: Atte Meretoja         
New Zealand
CDHB Christchurch Hospital Not yet recruiting
Christchurch, New Zealand, 8140
Contact: Jane Eagle    +64 3 378 6130    Jane.Eagle@cdhb.health.nz   
Principal Investigator: Teddy Wu         
Sponsors and Collaborators
Neuroscience Trials Australia
National Health and Medical Research Council, Australia
Monash University
Investigators
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Principal Investigator: Christopher Bladin The Florey Institute of Neuroscience & Mental Health Melbourne Brain Centre

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Responsible Party: Neuroscience Trials Australia
ClinicalTrials.gov Identifier: NCT03287076     History of Changes
Other Study ID Numbers: NTA1127
2018-004325-88 ( EudraCT Number )
First Posted: September 19, 2017    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Neuroscience Trials Australia:
stroke
glucose
exenatide
Additional relevant MeSH terms:
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Stroke
Cerebral Infarction
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Obesity Agents
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists