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
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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
- 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
- post stroke hyperglycaemia [ Time Frame: 90 days ]reduce the occurrence of post stroke hyperglycaemia (>7mmol/l).
- Modified Rankin Scale [ Time Frame: 90 days ]improve Modified Rankin Scale (mRS) at 90 days
- NIHSS [ Time Frame: 90 days ]improve NIHSS at 90 days
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
|Contact: Christopher Bladin||+61 3 9035 email@example.com|
|Contact: Fiona Ellery||+61 3 9035 firstname.lastname@example.org|
|Box Hill Hospital||Recruiting|
|Melbourne, Victoria, Australia, 3128|
|Contact: Christopher Bladin +61 3 9035 7338 email@example.com|
|Principal Investigator: Christopher Bladin|
|Principal Investigator:||Christopher Bladin||The Florey Institute of Neuroscience & Mental Health Melbourne Brain Centre|