Status:
UNKNOWN
Trial of EXenatide in Acute Ischaemic Stroke
Lead Sponsor:
Neuroscience Trials Australia
Collaborating Sponsors:
National Health and Medical Research Council, Australia
Monash University
Conditions:
Acute Ischemic Stroke
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
A multicentre, randomised controlled Trial of Exenatide versus standard care in Acute Ischemic Stroke
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
November 23 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT03287076
Start Date
November 23 2017
End Date
December 31 2021
Last Update
September 14 2021
Active Locations (15)
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1
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia, 2010
2
Liverpool Hospital
Liverpool, New South Wales, Australia, 2170
3
Sunshine Coast University Hospital
Birtinya, Queensland, Australia, 4575
4
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia, 4029