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Trial registered on ANZCTR


Registration number
ACTRN12624000727549p
Ethics application status
Submitted, not yet approved
Date submitted
9/05/2024
Date registered
13/06/2024
Date last updated
13/06/2024
Date data sharing statement initially provided
13/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
FRONTIER-AP Vision: Randomized controlled trial of endovascular versus standard medical therapy for stroke with occlusion of posterior cerebral artery.
Scientific title
FRONTIER-AP Vision: Randomized controlled trial of endovascular versus standard medical therapy for stroke with occlusion of posterior cerebral artery.
Secondary ID [1] 307807 0
Nil known
Universal Trial Number (UTN)
Trial acronym
FRONTIER-AP Vision
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stroke 333830 0
Condition category
Condition code
Stroke 324515 324515 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 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 CT and CTA will be performed 24-to-48-hour post intervention. At the investigator’s discretion, a repeat CT Perfusion or MRI may be performed at 24-to-48 hr.
Intervention code [1] 324271 0
Treatment: Devices
Comparator / control treatment
The standard care arm is either Alteplase or Tenecteplase (TNK) within 4.5 hours, or between 4.5-9 hours, it is alteplase or Tenecteplase or best medical therapy according to local guidelines and drug availability. 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] 332344 0
Disability will be measured by modified Rankin Scale (mRS).
Timepoint [1] 332344 0
3 months post-baseline
Primary outcome [2] 338369 0
Normalization of visual field deficit.
Timepoint [2] 338369 0
3 months post-baseline
Secondary outcome [1] 413107 0
The secondary outcome is the proportion who are eligible to drive by automated perimetry .
Timepoint [1] 413107 0
3 months post-baseline

Eligibility
Key inclusion criteria
Inclusion criteria:
1. Patients presenting with acute ischaemic stroke within 9 hours of stroke onset
2. Hemifield deficit
3. Pre-stroke modified Rankin Score (mRS) score of 0 or 1 or 2
4. Patient’s age is equal or greater than18 years (or as per local requirements)
5. Endovascular therapy expected to commence (arterial puncture) within 90 minutes of initial non-contrast CT brain.
6. Arterial occlusion on CT Angiography (CTA) or MR Angiography (MRA) of the posterior cerebral artery/PCA (P1 or P2).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:
1. Patients presenting with acute ischaemic stroke greater than 24 hours of stroke onset
2. Intracerebral haemorrhage (ICH) identified by CT or MRI
3. Rapidly improving symptoms at the discretion of the investigator
4. Pre-stroke modified Rankin Score (mRS) score of 2 or more (indicating previous disability)
5. Hypodensity in greater than 1/2 PCA territory on non-contrast CT
6. Basilar artery occlusion ipsilateral to the PCA clot
7. Contraindication to imaging with contrast agents
8. Any terminal illness such that the patient would not be expected to survive more than 1 year.
9. Patients with active cancer and undergoing treatment for cancer are excluded,
10. 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.
11. Pregnant women

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
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
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The analysis will be based on intention-to-treat. For dichotomous outcome (primary, safety and secondary outcomes, vessel recanalization), we will use logistic regression adjusting for covariates: age and NIHSS. The Significance is considered. Analysis will be performed with Stata software, version 17 (StataCorp). Serial measurement of visual function and quality of life measurements will be assessed using mixed model analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/08/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
230
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 23001 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [2] 23002 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [3] 23003 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [4] 23004 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 38313 0
3168 - Clayton
Recruitment postcode(s) [2] 38317 0
3050 - Royal Melbourne Hospital
Recruitment postcode(s) [3] 38318 0
5000 - Adelaide
Recruitment postcode(s) [4] 38319 0
2170 - Liverpool
Recruitment postcode(s) [5] 38320 0
2170 - Liverpool South
Recruitment outside Australia
Country [1] 24961 0
New Zealand
State/province [1] 24961 0
Canterbury

Funding & Sponsors
Funding source category [1] 312076 0
Government body
Name [1] 312076 0
National Health and Medical Research Council Clinical Trial and Cohort
Country [1] 312076 0
Australia
Primary sponsor type
Government body
Name
National Health and Medical Research Council Clinical Trial and Cohort
Address
National Health and Medical Research CouncilGPO Box 1421Canberra ACT 2601
Country
Australia
Secondary sponsor category [1] 313586 0
None
Name [1] 313586 0
None
Address [1] 313586 0
None
Country [1] 313586 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 311484 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 311484 0
Monash Health Human Research Ethics Committee,246 Clayton Rd, Clayton, 3168, VIC
Ethics committee country [1] 311484 0
Australia
Date submitted for ethics approval [1] 311484 0
03/06/2024
Approval date [1] 311484 0
Ethics approval number [1] 311484 0

Summary
Brief summary
The posterior cerebral artery (PCA) is an important artery which supplies the visual cortex in the occipital lobe and is key to visual function in the contralateral hemifield (loss of half visual field on side opposite to the stroke). Preservation of vision is essential in reading, return to work and driving post-stroke (deficit less than quarter of visual field). Unfortunately, spontaneous complete recovery of visual field occurs in 18.4% of cases and visual rehabilitation does not reduce hemifield deficit. The aim of this trial is to determine if clot extraction versus best medical therapy is the optimal treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121262 0
Prof Thanh Phan
Address 121262 0
Monash Health, 246 Clayton Rd Clayton 3168 VIC
Country 121262 0
Australia
Phone 121262 0
+61 385722612
Fax 121262 0
+61395946241
Email 121262 0
[email protected]
Contact person for public queries
Name 121263 0
Thanh Phan
Address 121263 0
Monash Health, 246 Clayton Rd Clayton 3168 VIC
Country 121263 0
Australia
Phone 121263 0
+61 385722612
Fax 121263 0
+61395946241
Email 121263 0
[email protected]
Contact person for scientific queries
Name 121264 0
Thanh Phan
Address 121264 0
Monash Health, 246 Clayton Rd Clayton 3168 VIC
Country 121264 0
Australia
Phone 121264 0
+61 385722612
Fax 121264 0
+61395946241
Email 121264 0
[email protected]

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 [email protected] (Thanh Phan) or [email protected] (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.