ANZCTR - Registration

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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]

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

Hyperglycemia

Condition category

Condition code

Neurological

Other neurological disorders

Stroke

Ischaemic

Metabolic and Endocrine

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]

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]

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]

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]

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]

During the period of administration of exenatide and till up to two weeks after stopping the medication.

Secondary outcome [2]

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]

72 hours post stroke

Secondary outcome [3]

Clinical outcome - NIHSS and modified Rankin Scale

Timepoint [3]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

University

Name [1]

Monash University eastern clinical research unit

Address [1]

Level 2, 5 Arnold street, Box Hill Hospital, Box Hill, Victoria 3128, Australia

Country [1]

Australia

Funding source category [2]

Other

Name [2]

Eastern Health Research Grant 2012

Address [2]

Level 2, 5 Arnold street, Box Hill Hospital, Box Hill, Victoria 3128,
Australia
The study has been approved this grant and any additional expenditure will be from the Monash university eastern clinical research unit (ECRU) fund.

Country [2]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Eastern Health Research Ethics Committee

Ethics committee address [1]

Level 4, 5 Arnold street, Box Hill Hospital, Victoria 3128

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

28/03/2012

Approval date [1]

17/08/2012

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Christopher Bladin

Address

Level 2, 5 Arnold street, Box Hill, Victoria 3128

Country

Australia

Phone

+61398954974

Fax

+61398999137

christopher.bladin@easternhealth.org.au

Contact person for scientific queries

Name

Christopher Bladin

Address

Level 2, 5 Arnold street, Box Hill, Victoria 3128

Country

Australia

Phone

+61398954974

Fax

+61398999137

christopher.bladin@easternhealth.org.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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