Trial of EXenatide in Acute Ischaemic Stroke

• Status: Active, not recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

Summary

A multicentre, randomised controlled Trial of Exenatide versus standard care in Acute Ischemic Stroke

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Neuroscience Trials Australia
• Collaborators: Monash University; National Health and Medical Research Council, Australia
• Treatments: Exenatide

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)