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Trial registered on ANZCTR


Registration number
ACTRN12622000880741
Ethics application status
Approved
Date submitted
2/06/2022
Date registered
21/06/2022
Date last updated
27/10/2023
Date data sharing statement initially provided
21/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Stroke in patients with Very large Ischaemic Core: Assessment of Reperfusion therapy Impact on Outcome (SICARIO-VLC)
Scientific title
Stroke in patients with Very large Ischaemic Core: Assessment of Reperfusion therapy Impact on disability Outcomes: SICARIO single arm trial on thrombectomy vs historical control.
Secondary ID [1] 306961 0
NHMRC MRFF 2020 Cardiovascular Health Mission APP2007317
Universal Trial Number (UTN)
Trial acronym
SICARIO-VLC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Ischaemic Stroke 326077 0
Condition category
Condition code
Stroke 323388 323388 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
SICARIO-VLC will include patients presenting with a baseline perfusion core lesion >100mL and will be allocated to receive thrombectomy. The device used will be at the proceduralist’s discretion.

The thrombolysis decision will be up to the treating physicians’ decision. This will minimize the chances of selection bias as the research team members are not interfering in the clinician’s judgment.

Two types of standard of care clot retrieval devices used. (brands may vary between countries)
1. Stent retrievers such as Trevo by Stryker, Solitaire by Medtronic.
2. Aspiration catheters such as Penumbra

Duration of thrombectomy procedure depends on complexity, approximately 1-2 hours. Procedure to be initiated within 2 hours of presentation as per protocol, performed by the neurointerventionalist.
Intervention code [1] 323406 0
Treatment: Other
Intervention code [2] 323407 0
Treatment: Surgery
Comparator / control treatment
All patients enrolled into SICARIO-VLC will all proceed to thrombectomy.
SICARIO-VLC follows a single arm Bayesian Optimal Phase 2 design where information about the performance of control participants is encapsulated through the objective performance criteria - numerical target values for futility and sufficient promise derived from historical data from INSPIRE registry collected over the period from 2015 to 2019.
Control group
Historical

Outcomes
Primary outcome [1] 331125 0
For SICARIO-VLC - The proportion of patients with modified Rankin Scale (mRS) 0-4 (no catastrophic outcome) at 3 months.
Timepoint [1] 331125 0
3 months post thrombectomy
Secondary outcome [1] 408849 0
SICARIO-VLC - Proportion of patients with mRS score 0-2 at 3 months.
Timepoint [1] 408849 0
3 months post thrombectomy
Secondary outcome [2] 408850 0
SICARIO-VLC - Proportion of patients with mRS score 0-3 at 3 months.
Timepoint [2] 408850 0
3 months post thrombectomy
Secondary outcome [3] 408851 0
SICARIO-VLC - Proportion of patients with mRS score 0-2 at 12 months
Timepoint [3] 408851 0
12 months post thrombectomy
Secondary outcome [4] 408852 0
SICARIO-VLC - Proportion of patients with mRS score 0-3 at 12 months
Timepoint [4] 408852 0
12 months post thrombectomy
Secondary outcome [5] 408853 0
SICARIO-VLC - Proportion of patients with mRS score 0-4 at 12 months
Timepoint [5] 408853 0
12 months post thrombectomy
Secondary outcome [6] 408854 0
SICARIO-VLC - disability severity assessed by mRS scores at 3 months.
Timepoint [6] 408854 0
3 months post thrombectomy
Secondary outcome [7] 408856 0
SICARIO-VLC - quality of life assessed by EQ-5D at 3 months and 12 months
Timepoint [7] 408856 0
3 months and 12 months post thrombectomy
Secondary outcome [8] 408857 0
SICARIO-VLC - overall health assessed by PROMS-10 at 3 months and 12 months
Timepoint [8] 408857 0
3 months and 12 months post thrombectomy
Secondary outcome [9] 428238 0
Proportion of patients with mRS score 0-4 at 3 months not requiring hemicraniectomy (treating physician criteria).
Collected via data linkage to hospital records
Timepoint [9] 428238 0
Secondary outcome [10] 428239 0
Proportion of patients with mRS score 0-4 at 3 months not requiring hemicraniectomy (treating physician criteria).
Collected via data linkage to hospital records
Timepoint [10] 428239 0
3 months post thrombectomy
Secondary outcome [11] 428240 0
Proportion of patients with mRS score 0-4 at 12 months not requiring hemicraniectomy (treating physician criteria).
Collected via data linkage to hospital records
Timepoint [11] 428240 0
3 months post thrombectomy
Secondary outcome [12] 428241 0
Proportion of patients with mRS score 0-4 at 12 months not requiring hemicraniectomy (treating physician criteria).
Collected via data linkage to hospital records
Timepoint [12] 428241 0
12 months post thrombectomy

Eligibility
Key inclusion criteria
Patients presenting with acute hemispheric ischemic stroke with onset (or the time last known to be well) within 24 hours.
• Presence of a baseline ischemic core of >100 mL (SICARIO-VLC) on CT perfusion imaging or diffusion-perfusion MRI processed with automated perfusion volumetric analysis (MIStar - Apollo Medical Imaging-, being the preferred software for the trial due to less variability in its outputs).
• Patient’s age is 18 years or above
• Premorbid modified Rankin Scale score 0 to 2.
• Presence of a large vessel occlusion on CTA or MRA.
Large vessel occlusion will be defined as a ‘potentially retrievable’ thrombus at one or more of the following sites: intracranial internal carotid (ICA), middle cerebral artery (MCA) first segment (M1) or combination of an extracranial segment of ICA and an intracranial occlusion (terminal ICA or MCA) -tandem occlusion-.
• Onset of acute imaging to groin puncture (in the patients randomized to thrombectomy) under 120 minutes.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Intracranial haemorrhage (ICH) or other diagnosis (e.g. tumour) identified by baseline imaging.
• Vertebro-basilar artery occlusion
• Pre-stroke mRS > 2 (indicating significant previous disability)
• Any terminal illness such that patient would not be expected to survive more than 1 year.
• 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.
• Pregnancy - women of childbearing age with a positive urine pregnancy test.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
SICARIO-VLC is designed to test the effect of endovascular thrombectomy (with or without thrombolysis) on three-month functional outcomes in the population defined by the size of baseline perfusion core lesion volume above 100mL..

The proportions of participants with positive primary outcome will be used as inputs for the decision to declare either futility or superiority that will be based on the Bayesian decision rules specified in the trial design section.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2022
Actual
29/11/2022
Date of last participant enrolment
Anticipated
1/07/2026
Actual
Date of last data collection
Anticipated
1/07/2027
Actual
Sample size
Target
150
Accrual to date
3
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 22215 0
John Hunter Hospital - New Lambton
Recruitment hospital [2] 22216 0
Liverpool Hospital - Liverpool
Recruitment hospital [3] 22217 0
Prince of Wales Hospital - Randwick
Recruitment hospital [4] 22218 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [5] 22219 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [6] 22220 0
Box Hill Hospital - Box Hill
Recruitment hospital [7] 22221 0
Sunshine Hospital - St Albans
Recruitment hospital [8] 22222 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [9] 22223 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 37379 0
2031 - Randwick
Recruitment postcode(s) [2] 37380 0
2065 - St Leonards
Recruitment postcode(s) [3] 37378 0
2170 - Liverpool
Recruitment postcode(s) [4] 37377 0
2305 - New Lambton
Recruitment postcode(s) [5] 37383 0
3021 - St Albans
Recruitment postcode(s) [6] 37381 0
3050 - Parkville
Recruitment postcode(s) [7] 37382 0
3128 - Box Hill
Recruitment postcode(s) [8] 37384 0
3168 - Clayton
Recruitment postcode(s) [9] 37385 0
5000 - Adelaide
Recruitment outside Australia
Country [1] 24732 0
Spain
State/province [1] 24732 0
Catalunya / Barcelona
Country [2] 25882 0
New Zealand
State/province [2] 25882 0
Christchurch
Country [3] 25916 0
New Zealand
State/province [3] 25916 0
Christchurch
Country [4] 25917 0
New Zealand
State/province [4] 25917 0
Christchurch
Country [5] 25925 0
New Zealand
State/province [5] 25925 0
Christchurch

Funding & Sponsors
Funding source category [1] 311278 0
Government body
Name [1] 311278 0
National Health Medical Research Council - Medical Research Future Fund
Country [1] 311278 0
Australia
Primary sponsor type
University
Name
The University of Newcastle
Address
University Drive, Callaghan, NSW 2308
Country
Australia
Secondary sponsor category [1] 312638 0
None
Name [1] 312638 0
Address [1] 312638 0
Country [1] 312638 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310785 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 310785 0
HNE Research Office
Address: Level 3, POD, HMRI, Lot 1 Kookaburra Circuit, New Lambton, NSW, 2305
Ethics committee country [1] 310785 0
Australia
Date submitted for ethics approval [1] 310785 0
30/01/2021
Approval date [1] 310785 0
24/01/2022
Ethics approval number [1] 310785 0
2021/ETH12220

Summary
Brief summary
SICARIO-VLC is designed to test the effect of endovascular thrombectomy (with or without thrombolysis) on three-month functional outcomes in the population defined by the size of baseline perfusion core lesion volume above 100mL.
Primary outcome will be the proportion of patients with modified Rankin Scale (mRS) 0-4 (no catastrophic outcome) at 3 months.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118854 0
Prof Christopher Levi
Address 118854 0
HNELHD Area Headquarters Building
John Hunter Hospital Campus
Locked Bag No. 1 Hunter Region Mail Centre
NSW 2310
Country 118854 0
Australia
Phone 118854 0
+61 2 49 236288
Fax 118854 0
+61 2 49 213488
Email 118854 0
christopher.levi@health.nsw.gov.au
Contact person for public queries
Name 118855 0
Ms Michelle Russell
Address 118855 0
Neurology Department
Level 2, John Hunter Hospital
Locked Bag No.1 Hunter Region Mail Centre
NSW 2310
Country 118855 0
Australia
Phone 118855 0
+61249213481
Fax 118855 0
+61249213488
Email 118855 0
michelle.russell@health.nsw.gov.au
Contact person for scientific queries
Name 118856 0
Prof Christopher Levi
Address 118856 0
HNELHD Area Headquarters Building
John Hunter Hospital Campus
Locked Bag No. 1 Hunter Region Mail Centre
NSW 2310
Country 118856 0
Australia
Phone 118856 0
+61 2 49 236288
Fax 118856 0
+61 2 49 213488
Email 118856 0
christopher.levi@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.