Exenatide in acute ischemic stroke- a randomised controlled trial

Phase 2

• Conditions: Acute ischemic stroke; Hyperglycemia; Neurological - Other neurological disorders; Stroke - Ischaemic; Metabolic and Endocrine - Other metabolic disorders

• Registration Number: ACTRN12612000957897
• Lead Sponsor: Monash University eastern clinical research unit

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-09-06
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 50

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Glycemic control in patients with acute ischemic stroke.<br>Capillary glucose levels will be measured using a continuous glucose monitoring system for the first 72 hours following admission. Following this, CGM will be stopped and finger-prick glucose will be done four time daily for the next 48 hours[CGM will be used to assess glucose levels in the first 72 hours. After this, finger prick glucose measurement will be done in the next 48 hours. Comparisons will be made between the glycemic control in both groups.]

Secondary Outcome Measures

Name	Time	Method
Final infarct size and recanalisation rate. All patients will have a MRI scan or CR scan of brain at 72 hours after admission. MRI scan will be the preferred modality, but if contraindicated, a CT scan will be done. This is a part of the standard stroke imaging protocol at Box Hill Hospital[72 hours post stroke];Clinical outcome - NIHSS and modified Rankin Scale[5 days and 3 months];Adverse events of exenatide - frequency or nausea, vomiting and hypoglycemic episodes. In addition any new adverse event will be documented and a causal relationship with exenatide will be explored. <br>Hypoglycemia will be defined as any glucose measurment less than 3.3 mmol/l or < 4mmol/l if accompanied by symptoms attributable to hypoglycemia.[During the period of administration of exenatide and till up to two weeks after stopping the medication.]