A Multicentre, randomised controlled Trial of Exenatide versus standard care in Acute Ischemic Stroke
Lead PI: Prof Chris Bladin
No. of Patients Currently Recruited: 200 No. of Patients Required: 528
Phase 2, multicentre, prospective, randomised, open label, blinded end-point (PROBE) trial with pre-planned adaptive sample size re-estimation. Primary Hypothesis: Treatment with short acting Exenatide (Byetta) in patients with acute ischaemic stroke will improve neurological outcome as measured by >8 point improvement in NIHSS stroke disability score (or NIHSS 0-1) at 7 days. The trial is still in recruitmemt phase. The 1st DSMB meeting occured in Nov 2019. The committee reviewed the data from the first 100 patients and was satisfied with the conduct of the trial and safety of the trial participant and recommended that the trial continue as planned.