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Trial registered on ANZCTR


Registration number
ACTRN12619001194156
Ethics application status
Approved
Date submitted
6/08/2019
Date registered
27/08/2019
Date last updated
25/10/2023
Date data sharing statement initially provided
27/08/2019
Date results information initially provided
25/10/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Neuropsychological Outcomes Following Acute Ischaemic Stroke
Scientific title
Neuropsychological Outcomes Following Endovascular Clot Retrieval and Intravenous Tissue Plasminogen Activator in Acute Ischaemic Stroke Patients
Secondary ID [1] 298949 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 313933 0
Condition category
Condition code
Stroke 312340 312340 0 0
Ischaemic

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Arm 1
Endovascular Clot Retrieval (ECR)
ECR will be administered to eligible patients who have a stroke due to large vessel occlusion within 24 hours of stroke onset, per standard care, in a public hospital setting.

Arm 2
Intravenous Tissue Plasminogen Activator (t-PA)
t-PA will be administered to eligible patients who have a stroke at the standard dose of 0.9mg per kilogram within four and half hours of stroke onset, per standard care, in a public hospital setting.

As this is a non-randomised trial, participants are assigned to arm 1 or arm 2 based on the treatment they receive from their medical team.

For this study, participants are being assessed 3-months post-stroke.

Retrospective data being collected relates to information about stroke severity and stroke location.
Intervention code [1] 315349 0
Not applicable
Comparator / control treatment
No treatment control group (standard care).
Control group
Active

Outcomes
Primary outcome [1] 320967 0
General Cognitive Functioning
Wechsler Adult Intelligence Scale, Fourth Edition (WAIS-IV)
Timepoint [1] 320967 0
3 months post-stroke.
Secondary outcome [1] 373560 0
Verbal Memory
Wechsler Memory Scale, Fourth Edition (WMS-IV: Logical Memory)
Timepoint [1] 373560 0
3 months post-stroke.
Secondary outcome [2] 373561 0
Verbal Fluency
Controlled Oral Word Association Test (COWAT)
Timepoint [2] 373561 0
3 months post-stroke.
Secondary outcome [3] 373562 0
Language
Boston Naming Test, Second Edition (BNT)
Timepoint [3] 373562 0
3 months post-stroke.
Secondary outcome [4] 373563 0
Visual Neglect
Behavioural Inattention Test, Conventional Subtests (BIT-C)
Timepoint [4] 373563 0
3 months post-stroke.
Secondary outcome [5] 373564 0
Depression
Hospital Anxiety and Depression Scale (HADS)
Timepoint [5] 373564 0
3 months post-stroke.
Secondary outcome [6] 373565 0
Anxiety
Hospital and Anxiety Depression Scale (HADS)
Timepoint [6] 373565 0
3 months post-stroke.
Secondary outcome [7] 373566 0
Basic Activities of Daily Living
Barthel Index (BI)
Timepoint [7] 373566 0
3 months post-stroke.
Secondary outcome [8] 373567 0
Instrumental Activities of Daily Living
Nottingham Extended ADL Scale (NEADL)
Timepoint [8] 373567 0
3 months post-stroke.
Secondary outcome [9] 373568 0
Degree of Disability
Modified Rankin Scale (mRS)
Timepoint [9] 373568 0
3 months post-stroke.
Secondary outcome [10] 373569 0
Fatigue
Fatigue Severity Scale (FSS)
Timepoint [10] 373569 0
3 months post-stroke.
Secondary outcome [11] 373570 0
Behavioral Change (pre-stroke to post-stroke)
Frontal Systems Behaviour Scale, Family Rating Form (FrSBE)
Timepoint [11] 373570 0
3 months post-stroke.
Secondary outcome [12] 373939 0
Non-Verbal Memory
Wechsler Memory Scale, Fourth Edition (WMS-IV: Visual Reproduction)
Timepoint [12] 373939 0
3 months post-stroke.
Secondary outcome [13] 373940 0
Verbal Learning & Memory
Rey Auditory Verbal Learning Test (RAVLT)
Timepoint [13] 373940 0
3 months post-stroke.
Secondary outcome [14] 373941 0
Non-Verbal Learning & Memory
Brief Visuospatial Memory Test, Revised (BVMT-R)
Timepoint [14] 373941 0
3 months post-stroke.
Secondary outcome [15] 373942 0
Cognitive Flexibility
Trail Making Test (TMT)
Timepoint [15] 373942 0
3 months post-stroke.
Secondary outcome [16] 373943 0
Inhibition
D-KEFS Colour-Word Interference Test
Timepoint [16] 373943 0
3 months post-stroke.
Secondary outcome [17] 373944 0
Executive Planning & Problem Solving
Tower of London, Drexel University (TOLDX)
Timepoint [17] 373944 0
3 months post-stroke.

Eligibility
Key inclusion criteria
Patients who have an ischaemic stroke and receive ECR, t-PA, or no treatment (standard care) in the acute phase (at the time of treatment on admission to stroke ward).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Experienced cognitive impairment prior to having a stroke (indicated by a score of two or more on the AD8 Dementia Screening Interview).
History of previous stroke or other neurological illness that is known to cause ongoing cognitive sequelae,
History of brain injury or psychiatric illness.
Did not speak fluent English before their stroke.
Do not have the capacity to provide consent.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
We are aiming for a total sample size of 90 participants with 30 participants in each of the three treatment conditions. For cross-sectional analysis of the treatment conditions at 3 months, a MANCOVA will be performed including all cognitive, emotional, and functional outcome measures, with likely covariates including premorbid cognitive functioning and stroke severity. This will be followed by assessment of univariate findings with appropriate Holm’s adjustment to the alpha level to control for Type 1 error.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/08/2019
Actual
28/08/2019
Date of last participant enrolment
Anticipated
31/03/2023
Actual
29/05/2023
Date of last data collection
Anticipated
30/06/2023
Actual
29/05/2023
Sample size
Target
90
Accrual to date
Final
62
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 14438 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 27452 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 303488 0
University
Name [1] 303488 0
La Trobe University
Country [1] 303488 0
Australia
Funding source category [2] 312666 0
Charities/Societies/Foundations
Name [2] 312666 0
Summer Foundation
Country [2] 312666 0
Australia
Primary sponsor type
University
Name
La Trobe Universuty
Address
School of Psychology and Public Health
George Singer Building
La Trobe University
Plenty Road & Kingsbury Drive
Bundoora
VIC 3086
Country
Australia
Secondary sponsor category [1] 303547 0
Hospital
Name [1] 303547 0
Monash Health
Address [1] 303547 0
Monash Medical Centre
246 Clayton Road
Clayton
VIC 3168
Country [1] 303547 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304015 0
Monash Health Human Reseacrh Ethics Committee
Ethics committee address [1] 304015 0
Research Support Services
Level 2, i Block,
Monash Medical Centre
246 Clayton Road
Clayton
VIC 3168
Ethics committee country [1] 304015 0
Australia
Date submitted for ethics approval [1] 304015 0
16/03/2018
Approval date [1] 304015 0
13/07/2018
Ethics approval number [1] 304015 0
HREC/18/MonH/96

Summary
Brief summary
The aim of the current study is to conduct a non-randomised three-arm parallel controlled clinical trial comparing the cognitive, emotional, and functional outcomes of acute ischaemic stroke patients treated with ECR and t-PA, as well as those who receive no treatment (neither ECR nor t-PA) in the acute phase.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 95570 0
Dr Robert Bourke
Address 95570 0
Neuropsychology Unit
Monash Medical Centre
246 Clayton Road
Clayton
VIC 3168
Country 95570 0
Australia
Phone 95570 0
+61 03 9594 3020
Fax 95570 0
Email 95570 0
robert.bourke@monashhealth.org
Contact person for public queries
Name 95571 0
Mr Sam Humphrey
Address 95571 0
School of Psychology and Public Health
George Singer Building
La Trobe University
Plenty Road & Kingsbury Drive
Bundoora
VIC 3086
Country 95571 0
Australia
Phone 95571 0
+61 0430544933
Fax 95571 0
Email 95571 0
18268051@students.latrobe.edu.au
Contact person for scientific queries
Name 95572 0
Mr Sam Humphrey
Address 95572 0
School of Psychology and Public Health
George Singer Building
La Trobe University
Plenty Road & Kingsbury Drive
Bundoora
VIC 3086
Country 95572 0
Australia
Phone 95572 0
+61 0430544933
Fax 95572 0
Email 95572 0
18268051@students.latrobe.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethics application did not mention IPD sharing.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.