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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 : December 21, 2017
Sponsor:
Collaborators:
Monash University
National Health and Medical Research Council, Australia
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

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, 2019
Estimated Study Completion Date : December 31, 2020

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



Information from the National Library of Medicine

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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
  • 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)

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
Contact: Christopher Bladin +61 3 9035 7338 chris.bladin@unimelb.edu.au
Contact: Fiona Ellery +61 3 9035 7042 fiona.ellery@florey.edu.au

Locations
Australia, Victoria
Box Hill Hospital Recruiting
Melbourne, Victoria, Australia, 3128
Contact: Christopher Bladin    +61 3 9035 7338    chris.bladin@unimelb.edu.au   
Principal Investigator: Christopher Bladin         
Sponsors and Collaborators
Neuroscience Trials Australia
Monash University
National Health and Medical Research Council, Australia
Investigators
Principal Investigator: Christopher Bladin The Florey Institute of Neuroscience & Mental Health Melbourne Brain Centre

Responsible Party: Neuroscience Trials Australia
ClinicalTrials.gov Identifier: NCT03287076     History of Changes
Other Study ID Numbers: NTA1127
First Posted: September 19, 2017    Key Record Dates
Last Update Posted: December 21, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
Stroke
Ischemia
Cerebral Infarction
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
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists