Exenatide in acute ischemic stroke- a randomised controlled trial

Exenatide in acute ischemic stroke - a randomised controlled trial to look at its effect on post-stroke hyperglycemia, final infarct size and recanalisation and clinical outcome at 3 months

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000957897

Acronym

EXAIS

Enrollment

Registered

2012-09-06

Start date

2012-10-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study will investigate the use of a drug called Exenatide in patients with acute ischaemic stroke. Exenatide is a drug currently approved for use in patients with type 2 diabetes to help control glucose levels. Research in animals and other laboratory studies suggests that exenatide may have a protective effect on brain cells by protecting cells that are at risk of dying in ischaemic stroke, as well as controlling glucose levels. Exenatide has also been shown to reduce the area of brain damaged by stroke. In this study we aim to have two groups of 25 patients – an exenatide treatment group and a control group. One group will receive an exenatide injection twice daily for 5 days after stroke, with the first dose given within 9 hours of the onset of stroke symptoms. These patients will also receive either metoclopramide 10 mg or ondansetron 4 mg twice daily intravenously to prevent nausea and vomiting for the first 3 days. The control group will have standard stroke care without exenatide treatment. Patients in both groups are also eligible to receive tPA therapy. Blood tests will be taken on days 0,1, 3, 5, 7 and 14 to assess glucose levels and other blood markers. Standard imaging for stroke patients will be done for participants in the study, including a CT scan before starting the trial and CT or MRI 3-5 days after the stroke. All the patients will also have continuous glucose monitoring done in the first 72 hours. This will be done by equipment called Guardian real-time CGM system (Medtronic), which has a sensor with a subcutaneous needle. We aim to look for any significant differences between the two groups for blood sugar control, clinical outcome and size of stroke on CT/MRI. We will also monitor participants closely for adverse events that may be linked to exenatide treatment.

Interventions

Administering Exenatide injection 5 mcg twice daily to a selected group of acute ischemic stroke patients within 9 hours of stroke onset. Exenatide will be given for a period of 5 days maximum and then stopped. Exenatide group patients will receive metoclopramide 10 mg or ondansetron 4mg twice daily intravenously for the first three days of exenatide treatment

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

Age 18-90 years Stroke symptom onset within 9 hours Measurable NIHSS of 4-22 Blood sugar level on admission less than or equal to 3mmol/L Pre-morbid modified Rankin Scale (mRS) score of 0-2 CT Brain has excluded intracerebral haemorrhage

Exclusion criteria

Unlikely to survive beyond 14 days Have a known allergy or hypersensitivity to exenatide Pregnant (known or suspected) or breast feeding Diabetic patients already on exenatide, or combination insulin and oral hypoglycaemic agents Past history of pancreatitis or evidence of active pancreatitis Patients with other severe gastrointestinal disease like gastroparesis and dumping syndrome Patients with end stage renal disease (creatinine clearance < 30 ml/min)

Outcome results