Trial of EXenatide in Acute Ischaemic Stroke

What Was Tested

The trial (phase 2) is built around Exenatide.

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

It had two arms (groups): Active (experimental) and Standard Care (no intervention).

Patients will receive exenatide injections.

Standard care for stroke as per hospital protocol.

The registry classes the interventions as drug.

More on the Plan

Overview: Elevated blood glucose levels are common in many acute diseases, resulting in worse clinical outcomes.

Overall, blood glucose levels remained consistently lower (and less variable) in the exenatide group, and most noticeably in those stroke patients with known diabetes.

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).

Who Took Part

350 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Males and females 18 years or older. Acute Ischaemic Stroke - CT brain exclusion of haemorrhagic stroke. First trial treatment possible within 9 hours of stroke onset. Pre-morbid /mRS score of 0-2.

The full record lists 5 inclusion and 11 exclusion criteria; among the exclusions: haemorrhagic stroke; poor clinical prognosis /palliation (considered unlikely to survive beyond 14 days post stroke); any known allergy or hypersensitivity to exenatide.

How the Study Was Run

It was run as a randomized, parallel-group and single-blind study.

The participants were allocated by chance, so the Exenatide group and the comparison group should start out alike.

The Exenatide group and the comparison group ran side by side rather than switching.

In this single-blind Exenatide study one party knew the assignments and the other did not.

Those kept unaware of assignments: outcomes assessor.

It started in 2017-11-23 with completion listed for 2021-10-04.

It ran at 15 sites in Australia (13), Finland (1) and New Zealand (1).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 3 secondary outcomes, for example post stroke hyperglycaemia, Modified Rankin Scale and NIHSS.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Exenatide in 350 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Exenatide compound page, all human trials.