Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001232527p
Ethics application status
Not yet submitted
Date submitted
27/08/2024
Date registered
9/10/2024
Date last updated
9/10/2024
Date data sharing statement initially provided
9/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Stroke Thrombectomy Access: does it Yield better Home Outcomes and decreased Morbidity in Elderly versus standard thrombolysis? (STAY-HOME trial)
Scientific title
Stroke Thrombectomy Access: does it Yield better Home Outcomes and decreased Morbidity in Elderly versus standard thrombolysis? (STAY-HOME trial)
Secondary ID [1] 312827 0
None
Universal Trial Number (UTN)
Trial acronym
STAY-HOME
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 334935 0
Condition category
Condition code
Stroke 331473 331473 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients randomized to the thrombectomy arm will have clot extraction or aspiration catheter in the angiographic suite. This procedure may be performed under general anaesthesia. This decision is up to the interventional radiologists performing the procedure. The procedure may take 1 hour but can be longer for complex anatomy or clot. Following the procedure the interventional neuroradiologists will document the procedure in electronic medical record. Post-intervention: A non-contrast Computed Tomography (CT) and CT Angiography will be performed 24-to-48-hour post intervention. At the investigator’s discretion, a repeat CT Perfusion or Magnetic Resonance IMaging (MRI) may be performed at 24-to-48 hr.
Intervention code [1] 329374 0
Treatment: Devices
Comparator / control treatment
The standard care arm is either intravenous Alteplase or Tenecteplase (TNK) within 4.5 hours, or between 4.5-9 hours or best medical therapy according to local guidelines and drug availability. The dose for alteplase is 0.9 mg/kg and for tenecteplase it is 0.25mg/kg. The local site can choose between these two drugs. The best medical therapy option recognizes that between 4.5 - 9 hours, thrombolytic drug is not yet widely adopted in Asia. From 9- 24 hours, it’s best medical therapy. The type of therapy used will be verified by checking electronic medical record.
Control group
Active

Outcomes
Primary outcome [1] 339212 0
Hierarchical outcome of return to baseline modified Rankin score 3 if baseline was modified Rankin of 3 or return to baseline modified Rankin of 4 if baseline was modified Rankin of 4.
Timepoint [1] 339212 0
3 months post-baseline
Primary outcome [2] 339433 0
Each dimension of European Quality of life (EQ-5D-5L)
Timepoint [2] 339433 0
3 months post-baseline
Primary outcome [3] 339434 0
return home if from home, return nursing home if from nursing home
Timepoint [3] 339434 0
3 months post-baseline
Secondary outcome [1] 439095 0
Return to baseline status
Timepoint [1] 439095 0
3 months post-baseline

Eligibility
Key inclusion criteria
1. Patients presenting with acute ischaemic stroke within 24 hours of stroke onset (in line with current criteria for thrombolysis).
2. National Institute of Health Stroke Scale (NIHSS)>4
3. Pre-stroke modified Rankin Score (mRS) score of 3 or 4
4. Patient’s age is 18 years and over (or as per local requirements)
5. Endovascular therapy (arterial puncture) within 90 minutes of initial CT brain.
6. Arterial occlusion on CT Angiography or MR Angiography (MRA) of large vessel occlusion (LVO)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients presenting with acute ischaemic stroke >24 hours of stroke onset.
2. Intracranial haemorrhage identified by CT or MRI.
3. Rapidly improving symptoms at the discretion of the investigator
4. Pre-stroke modified Rankin Score (mRS) score of <3 (indicating previous disability)
5. Hypodensity in >1/2 MCA or ACA territory on non-contrast CT.
6. Contraindication to imaging with contrast agents (requirement for performing thrombectomy)
7. Any terminal illness such that the patient has life expectance less than 1 year.
8. Patients with active cancer and undergoing treatment for cancer are excluded.
9. Any condition that, in the judgment of the investigator, could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study.
10. Pregnancy

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)
Yes. Allocation concealment is performed by central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The analysis will be based on intention-to-treat. The analysis uses the win ratio hierarchy of outcomes: return to baseline modified Rankin score 3 if baseline was modified Rankin of 3 or return to baseline modified Rankin of 4 if baseline was modified Rankin of 4, return home if from home, return nursing home if from nursing home, and each dimension of EQ-5D-5L. The Wins are declared when one is clearly better and if there is a tie then the assessment is moved down to the next level and so. The Win Ratio is the ratio of winners and losers with associated 95% confidence interval.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/01/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA,VIC
Recruitment hospital [1] 27016 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [2] 27017 0
The Alfred - Melbourne
Recruitment hospital [3] 27018 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [4] 27019 0
Liverpool Hospital - Liverpool
Recruitment hospital [5] 27020 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 43087 0
3050 - Parkville
Recruitment postcode(s) [2] 43088 0
3004 - Melbourne
Recruitment postcode(s) [3] 43089 0
5000 - Adelaide
Recruitment postcode(s) [4] 43090 0
2170 - Liverpool
Recruitment postcode(s) [5] 43091 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 26529 0
Viet Nam
State/province [1] 26529 0
Ho Chi Minh
Country [2] 26530 0
New Zealand
State/province [2] 26530 0
canterbury

Funding & Sponsors
Funding source category [1] 317266 0
Government body
Name [1] 317266 0
National Health and Medical Research Council Clinical Trial and Cohort Studies Grant
Country [1] 317266 0
Australia
Primary sponsor type
Government body
Name
National Health and Medical Research Council
Address
Country
Australia
Secondary sponsor category [1] 319544 0
None
Name [1] 319544 0
Address [1] 319544 0
Country [1] 319544 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 316005 0
Monash Health Human Research Ethics Committee A
Ethics committee address [1] 316005 0
Ethics committee country [1] 316005 0
Australia
Date submitted for ethics approval [1] 316005 0
28/10/2024
Approval date [1] 316005 0
Ethics approval number [1] 316005 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 136474 0
Prof Thanh Phan
Address 136474 0
246 Clayton Rd Clayton, VIC3168 Australia, Monash Medical Centre
Country 136474 0
Australia
Phone 136474 0
+61 385722612
Fax 136474 0
Email 136474 0
thanh.phan@monash.edu
Contact person for public queries
Name 136475 0
Thanh Phan
Address 136475 0
246 Clayton Rd Clayton VIC 3168 Australia, Monash Medical Centre
Country 136475 0
Australia
Phone 136475 0
+61 385722612
Fax 136475 0
Email 136475 0
thanh.phan@monash.edu
Contact person for scientific queries
Name 136476 0
Thanh Phan
Address 136476 0
246 Clayton Rd Clayton, VIC 3168, Australia, Monash Medical Centre
Country 136476 0
Australia
Phone 136476 0
+61 385722612
Fax 136476 0
Email 136476 0
thanh.phan@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
anonymised trial data including randomisation allocation, baseline characteristics and outcome
When will data be available (start and end dates)?
The data will be available 24 months after publication of trial results and for 5 years
Available to whom?
trialists on request
Available for what types of analyses?
individual data metaanalysis
How or where can data be obtained?
from principal investigators thanh.phan@monash.edu (Thanh Phan) or bernard.yan@mh.org.au (Bernard Yan)


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.