Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000957897
Ethics application status
Approved
Date submitted
23/03/2012
Date registered
6/09/2012
Date last updated
6/09/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Exenatide in acute ischemic stroke- a randomised controlled trial
Scientific title
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
Secondary ID [1] 280206 0
NIL
Universal Trial Number (UTN)
U1111-1129-4139
Trial acronym
EXAIS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute ischemic stroke 286146 0
Hyperglycemia 286381 0
Condition category
Condition code
Neurological 286342 286342 0 0
Other neurological disorders
Stroke 286623 286623 0 0
Ischaemic
Metabolic and Endocrine 286624 286624 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 284536 0
Treatment: Drugs
Comparator / control treatment
Control group will be 25 patients of acute ischemic stroke who will be randomly allocated. All controls will receive standard stroke therapy similar to the Exenatide group. Standard stroke therapy includes thrombolytic therapy with tissue plasminogen activator to eligible patients, admission to stroke unit, supportive treatment and treatment of complications, antiplatetlet, anticoagulant, antihypertensive treatment as appropriate. Box Hill stroke unit follows protocols advocated by the national stroke foundation and this will be adhered to in the management of patients in both groups
Control group
Active

Outcomes
Primary outcome [1] 286806 0
Glycemic control in patients with acute ischemic stroke.
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
Timepoint [1] 286806 0
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 [1] 296701 0
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.
Hypoglycemia will be defined as any glucose measurment less than 3.3 mmol/l or < 4mmol/l if accompanied by symptoms attributable to hypoglycemia.
Timepoint [1] 296701 0
During the period of administration of exenatide and till up to two weeks after stopping the medication.
Secondary outcome [2] 296702 0
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
Timepoint [2] 296702 0
72 hours post stroke
Secondary outcome [3] 296703 0
Clinical outcome - NIHSS and modified Rankin Scale
Timepoint [3] 296703 0
5 days and 3 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
50 patients with acute ischemic stroke will be selected as per inclusion criteria and randomised to either receive Exenatide injection 5 mcg BD or to no injection. The control group will receive all other standard stroke therapy like the Exenatide group. Allocation will be concealed as described below.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation will be used to allocate the participants to the two groups. A statistician who is not involved in the recruitment and treatment of patients will create this allocation list. The allocation list will be stored in the Pharmacy Department away from the Emergency Department and Stroke Ward where patients are assessed. Pharmacy staff will be instructed to keep this list private and only reveal treatment allocation after receiving evidence that the patient is eligible for and consented for the study.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284957 0
University
Name [1] 284957 0
Monash University eastern clinical research unit
Country [1] 284957 0
Australia
Funding source category [2] 284958 0
Other
Name [2] 284958 0
Eastern Health Research Grant 2012
Country [2] 284958 0
Australia
Primary sponsor type
University
Name
Monash University eastern clinical research unit
Address
Level 2, 5 Arnold street, Box Hill Hospital, Box Hill, Victoria 3128, Australia
Country
Australia
Secondary sponsor category [1] 283828 0
None
Name [1] 283828 0
Address [1] 283828 0
Country [1] 283828 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286967 0
Eastern Health Research Ethics Committee
Ethics committee address [1] 286967 0
Level 4, 5 Arnold street, Box Hill Hospital, Victoria 3128
Ethics committee country [1] 286967 0
Australia
Date submitted for ethics approval [1] 286967 0
28/03/2012
Approval date [1] 286967 0
17/08/2012
Ethics approval number [1] 286967 0
E55/1112

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33971 0
Address 33971 0
Country 33971 0
Phone 33971 0
Fax 33971 0
Email 33971 0
Contact person for public queries
Name 17218 0
Christopher Bladin
Address 17218 0
Level 2, 5 Arnold street, Box Hill, Victoria 3128
Country 17218 0
Australia
Phone 17218 0
+61398954974
Fax 17218 0
+61398999137
Email 17218 0
christopher.bladin@easternhealth.org.au
Contact person for scientific queries
Name 8146 0
Christopher Bladin
Address 8146 0
Level 2, 5 Arnold street, Box Hill, Victoria 3128
Country 8146 0
Australia
Phone 8146 0
+61398954974
Fax 8146 0
+61398999137
Email 8146 0
christopher.bladin@easternhealth.org.au

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Results publications and other study-related documents

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