Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001170314
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
26/08/2026
Date registered
Help: Date registered
21/09/2026
Date last updated
Help: Date last updated
21/09/2026
Date data sharing statement initially provided
Help: Data sharing statement date
21/09/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Implementation of CYP2C19 testing to guide antiplatelet therapy
Scientific title
The GUIDED-APT Trial: Implementation of CYP2C19 testing to guide antiplatelet therapy in percutaneous coronary intervention patients
Additional trial identifiers [1] 318419 0
Nil
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Acute Coronary Syndrome 343274 0
Recurrent Ischaemic Events 343275 0
Coronary Artery Disease 343276 0
Condition category
Condition code
Cardiovascular 339392 339392 0 0
Coronary heart disease
Cardiovascular 339682 339682 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
This is a hybrid type 3 implementation trial evaluating a CYP2C19 pharmacogenomic testing service into routine clinical care for patients undergoing percutaneous coronary intervention (PCI). PCI is the cornerstone treatment of acute coronary syndrome (ACS). It is regularly performed as part of standard clinical care in accordance with usual hospital practice. The intervention under evaluation is the pharmacogenomic testing service and associated genotype-guided prescribing recommendations.
Eligible patients will be identified by their treating cardiologist and invited to participate in the study either prior to, or after their PCI. Following provision of informed consent (by the cardiologist), the treating cardiologist will obtain a blood sample in the hospital catheterisation laboratory for CYP2C19 genotyping. The consent and blood collection procedures are expected to take approximately 10-15 minutes in total, with blood collection requiring less than 5 minutes.
Blood samples will be transported to a NATA-accredited (National Association of Testing Authorities) laboratory for genotyping. The test results are entered into the patient's electronic medical records approximately 2 weeks following the receipt of the sample. The test results are also sent to the patient, their GP and treating cardiologists.
The treating cardiologist will review the genotype-guided prescribing recommendations and determine whether a change in antiplatelet therapy is clinically appropriate. For patients with actionable CYP2C19 genotypes, this may involve switching from clopidogrel to an alternative P2Y12 inhibitor in accordance with Clinical Pharmacogenetics Implementation Consortium (CPIC) therapeutic recommendations and the treating clinician's clinical judgement. Implementation of genotype-guided prescribing recommendations, including whether antiplatelet therapy is changed, forms part of the intervention being evaluated. The primary implementation outcome is adoption, defined as the proportion of genotype-guided prescribing recommendations that are accepted and acted upon by prescribers among patients with actionable test results.
Adherence and fidelity to the intervention will be assessed through review of participants' electronic medical records. This will include documentation of whether genotype-guided prescribing recommendations were implemented, subsequent changes to antiplatelet therapy, and whether those changes were maintained over time. We will also monitor cardiovascular-related hospital readmissions and antiplatelet therapy changes during follow-up to evaluate the downstream impact of genotype-guided prescribing decisions.
Patients will complete a baseline survey at the time of PCI (pre-genotyping), including the EQ-5D-5L quality-of-life questionnaire. Patients will be followed for 12-months post-PCI (post-genotyping), at which point a follow-up survey will be administered assessing quality of life (EQ-5D-5L questionnaire), medication changes, hospital readmissions, and their experiences with the pharmacogenomic testing service, including perceived benefits, barriers, and areas for improvement.
Intervention code [1] 335114 0
Prevention
Intervention code [2] 335319 0
Early detection / Screening
Description of the comparator or control
The control group is a historical control of patients undergoing PCI who were not provided pharmacogenomic testing. This historical control has been obtained through a retrospective audit of electronic medical records from the five participating hospitals where the CYP2C19 genotyping intervention will be implemented. Medical records of patients undergoing PCI between 01/06/2023 – 01/06/2025 were reviewed. The retrospective audit assessed antiplatelet prescribing patterns following PCI, including whether antiplatelet therapy was changed, the nature of the change (e.g. switching between P2Y12 inhibitors, discontinuation, escalation or de-escalation of therapy), and the timing of any medication changes. The audit also assessed hospital readmissions, including the incidence, timing and documented reason for readmission (e.g. recurrent cardiovascular events, bleeding events, stent thrombosis, or other causes). Participants in the historical control group did not undergo CYP2C19 pharmacogenomic testing. As this is an audit of existing records, participants in the historical control group were not administered any study surveys. These surveys will be administered only to participants prospectively enrolled in the intervention group receiving pharmacogenomic testing.
Control group
Historical

Outcomes
Primary outcome [1] 346591 0
Evaluate the adoption of CYP2C19-guided antiplatelet prescribing recommendations among post-PCI patients with actionable genetic variants.
Timepoint [1] 346591 0
12-months post-PCI
Secondary outcome [1] 466570 0
Determine the incidence of cardiovascular-related readmissions post-genotyping.
Timepoint [1] 466570 0
12-months post-PCI
Secondary outcome [2] 466571 0
Determine the cost-effectiveness of delivering CYP2C19 genotyping within the Australian healthcare setting.
Timepoint [2] 466571 0
12-months post-PCI

Eligibility
Key inclusion criteria
Any patient that has been admitted to the study hospital site who is undergoing a percutaneous coronary intervention.
Willingness to give written informed consent (or provide consent through an authorised representative/guardian), and willingness to participate and comply with the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Participants who have previously obtained a pharmacogenomic test result.
Unable to provide written informed consent, or consent through an authorised representative/guardian.

Study design
Purpose of the study
Prevention
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
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2027
Actual
Date of last participant enrolment
Anticipated
31/12/2029
Actual
Date of last data collection
Anticipated
31/12/2030
Actual
Sample size
Target
5000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 322780 0
Government body
Name [1] 322780 0
Australian Department of Health, Disability and Ageing, Medical Research Future Fund - Genomics Health Futures Grant
Country [1] 322780 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 325930 0
None
Name [1] 325930 0
Address [1] 325930 0
Country [1] 325930 0
Other collaborator category [1] 284059 0
Government body
Name [1] 284059 0
NSW Health Pathology
Address [1] 284059 0
Country [1] 284059 0
Australia
Other collaborator category [2] 284060 0
Government body
Name [2] 284060 0
Sydney Local Health District
Address [2] 284060 0
Country [2] 284060 0
Australia
Other collaborator category [3] 284061 0
Government body
Name [3] 284061 0
Western Sydney Local Health District
Address [3] 284061 0
Country [3] 284061 0
Australia
Other collaborator category [4] 284062 0
Government body
Name [4] 284062 0
Illawara Shoalhaven Local Health District
Address [4] 284062 0
Country [4] 284062 0
Australia
Other collaborator category [5] 284063 0
Government body
Name [5] 284063 0
Northern Sydney Local Health District
Address [5] 284063 0
Country [5] 284063 0
Australia
Other collaborator category [6] 284084 0
Government body
Name [6] 284084 0
Western NSW Local Health District
Address [6] 284084 0
Country [6] 284084 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 321221 0
Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 321221 0
Ethics committee country [1] 321221 0
Australia
Date submitted for ethics approval [1] 321221 0
30/04/2026
Approval date [1] 321221 0
18/06/2026
Ethics approval number [1] 321221 0
ETH00982

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

Contacts
Principal investigator
Name 153054 0
A/Prof Sophie Stocker
Address 153054 0
Rm No N405, Building No A15 (Pharmacy and Bank Building), Science Road, Camperdown, The University of Sydney, NSW 2006
Country 153054 0
Australia
Phone 153054 0
+61 2 9114 4756
Fax 153054 0
Email 153054 0
[email protected]
Contact person for public queries
Name 153055 0
Sophie Stocker
Address 153055 0
Rm No N405, Building No A15 (Pharmacy and Bank Building), Science Road, Camperdown, The University of Sydney, NSW 2006
Country 153055 0
Australia
Phone 153055 0
+61 2 9114 4756
Fax 153055 0
Email 153055 0
[email protected]
Contact person for scientific queries
Name 153056 0
Sophie Stocker
Address 153056 0
Rm No N405, Building No A15 (Pharmacy and Bank Building), Science Road, Camperdown, The University of Sydney, NSW 2006
Country 153056 0
Australia
Phone 153056 0
+61 2 9114 4756
Fax 153056 0
Email 153056 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.