Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000038796
Ethics application status
Approved
Date submitted
23/10/2021
Date registered
17/01/2022
Date last updated
17/01/2022
Date data sharing statement initially provided
17/01/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pharmacogenomics guided antiplatelet selection strategy prior to intracranial or carotid stenting.
Scientific title
Pharmacogenomics guided antiplatelet selection strategy prior to intracranial or carotid stenting: investigating the impact on platelet aggregation at time of surgery
Secondary ID [1] 305643 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
carotid stenosis
 324066 0
aneurysm 324067 0
Condition category
Condition code
Neurological 321578 321578 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pharmacogenomics guided antiplatelet selection strategy prior to intracranial or carotid stenting. To determine whether pharmacogenomics testing allows accurate prediction of antiplatelet response prior to neurointerventional procedures. The study will involve one additional blood test to determine the pharmacogenomic profile for clopidogrel metabolism. Based on this patients who are responders will be started on the clopidogrel 75mg daily and those who are not will be started on a second line medication at standard doses ticagrelor 90mg twice daily or prasugrel 10mg daily. These medications are oral and given for a period as clinically indicated by the type and radiological appearances and clinical condition of the patient. This would usually be for a period of 6-12 weeks depending on the stent. Longer term dual antiplatelet therapy may be continued for select cases if there is an ongoing thromboembolic risk due to stent or patient factors. Compliance will be monitored on routine clinical review. Platelet response will be measured with the multiplate assay based on ADP values prior to any procedure.
Intervention code [1] 322034 0
Prevention
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329347 0
To determine if pharmacogenomics-guided selection of antiplatelet therapy results in any change in impedance aggregometry response ( defined as ADP < 40 U) at 7 days for patients undergoing neurointerventional procedures intracranial or carotid stenting using a blood sample.
Timepoint [1] 329347 0
On day of procedure
Secondary outcome [1] 403096 0
1. Risk of haemorrhage determined by review of clinical history with patient at time of clinical follow up post procedure.
Timepoint [1] 403096 0
at time of clinical follow up post procedure 1-3 months.
Secondary outcome [2] 403097 0

2. Delay in procedure due to inadequate response ie defined as ADP > 40 U. This will be determined by patient and clinician review at time of clinical follow up.
Timepoint [2] 403097 0
At time of procedure or at routine clinical follow up in 1-3 months.
Secondary outcome [3] 404196 0
Adverse reactions to medication assessed by a clinical examination
Timepoint [3] 404196 0
1-3 months post procedure at time of routine clinical follow up.

Eligibility
Key inclusion criteria
Patient who are candidates for stenting.
Patients who are able to comply with dual antiplatelet therapy
Patients are willing to give informed written consent.
Patients aged 18 or older will be eligible.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Contraindications to antiplatelet treatment including but not limited to listed below
Acute or ongoing bleeding
Pregnancy
Thrombocytopenia ie. platelets < 50,000 per microL
Severe liver disease as determined by the treating physician
Renal Failure eGFR < 30 ml/min/1.73m2
Inability to comply with follow up visits.
Concurrent requirement for anticoagulation with warfarin or a NOAC
TPA use within the last 24 hours

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
22/11/2021
Date of last participant enrolment
Anticipated
25/11/2024
Actual
Date of last data collection
Anticipated
24/02/2025
Actual
Sample size
Target
80
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 20870 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 35691 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 310001 0
Charities/Societies/Foundations
Name [1] 310001 0
Ramsay Foundation (Ramsay Grant)
Country [1] 310001 0
Australia
Primary sponsor type
Hospital
Name
Royal North Shore Hospital
Address
Reserve Rd
St Leonards NSW 2065
Country
Australia
Secondary sponsor category [1] 311052 0
None
Name [1] 311052 0
Address [1] 311052 0
Country [1] 311052 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309711 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 309711 0
Level 13 Kolling Building, Royal North Shore Hospital, Reserve Road, St Leonards, NSW, 2065
Ethics committee country [1] 309711 0
Australia
Date submitted for ethics approval [1] 309711 0
Approval date [1] 309711 0
17/03/2021
Ethics approval number [1] 309711 0
2021/ETH00377

Summary
Brief summary
For most endovascular stenting procedures dual antiplatelet therapy is necessary with a combination of antiplatelet medications. The standard medication regime is a trial of the antiplatelet clopidogrel in combination with aspirin, this study pioneers a tailored medication approach to the genetic profile of each patient.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 115126 0
Dr Alice Ma
Address 115126 0
Neurosurgery Department
Royal North Shore Hospital
Reserve Road, ST. LEONARDS New South Wales 2065
Country 115126 0
Australia
Phone 115126 0
+61 2 9926 7111
Fax 115126 0
Email 115126 0
alice.ma@health.nsw.gov.au
Contact person for public queries
Name 115127 0
Dr Alice Ma
Address 115127 0
Neurosurgery Department
Royal North Shore Hospital
Reserve Road, ST. LEONARDS New South Wales 2065
Country 115127 0
Australia
Phone 115127 0
+61 2 9926 7111
Fax 115127 0
Email 115127 0
alice.ma@health.nsw.gov.au
Contact person for scientific queries
Name 115128 0
Dr Alice Ma
Address 115128 0
Neurosurgery Department
Royal North Shore Hospital
Reserve Road, ST. LEONARDS New South Wales 2065
Country 115128 0
Australia
Phone 115128 0
+61 2 9926 7111
Fax 115128 0
Email 115128 0
alice.ma@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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13739Study protocol  alice.ma@health.nsw.gov.au
13741Informed consent form    383017-(Uploaded-23-10-2021-18-41-43)-Study-related document.doc



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.