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Implementation of a CYP2C19 testing service to guide antiplatelet therapy

Feasibility of implementing a CYP2C19 testing service to guide antiplatelet treatment for patients who have undergone percutaneous coronary intervention into clinical practice

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12626000055303
Enrollment
70
Registered
2026-01-15
Start date
2026-02-01
Completion date
2026-06-01
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

In this project we will implement a CYP2C19 genetic testing service in patients who are undergoing percutaneous coronary intervention, to guide antiplatelet therapy and reduce the risk of recurrent ischaemic events. The aim of the project is to investigate the feasibility of this service using the RE-AIM framework. DNA samples of participants will be collected via a blood sample and sent to NSW Health Pathology for testing and a pharmacogenomic report. The report will be reviewed by the treating cardiologist who will interpret and make recommendations regarding antiplatelet therapy. Recommendations will be communicated to the participant, their general practitioner and referring cardiologist. Barriers and facilitators to implement this service will be identified using semi-structured interviews with stakeholders. We expect to understand the feasibility and clinical utility of implementing a CYP2C19-guided antiplatelet service for secondary prevention of recurrent ischaemic events.

Interventions

This is a mixed methods research study consisting of a CYP2c19 genetic testing service (Phase 1) and qualitative methods (Phase 2). Phase 1 is a non-randomised prospective clinical study that implements a CYp2C19 genetic testing service in patients that have undergone a percutaneous coronary intervention, to inform antiplatelet therapy. The intervention is a pharmacogenomic test using a blood sample. Approximate turnaround time between the pharmacogenomic test and the results is five days. The r

This is a mixed methods research study consisting of a CYP2c19 genetic testing service (Phase 1) and qualitative methods (Phase 2). Phase 1 is a non-randomised prospective clinical study that implements a CYp2C19 genetic testing service in patients that have undergone a percutaneous coronary intervention, to inform antiplatelet therapy. The intervention is a pharmacogenomic test using a blood sample. Approximate turnaround time between the pharmacogenomic test and the results is five days. The results of the pharmacogenomic test will be reviewed by the participants treating cardiologist who will make prescribing considerations (e.g. ticagrelor or prasugrel instead of clopidogrel if the participant has a CYP2C19 loss-of-function genotype (defined as poor or intermediate metaboliser)). The treating cardiologist will communicate (via letter) the results and recommendations to the participants general practitioner and referring cardiologist. Practitioners reserve the right not to action antiplatelet therapy changes based on their clinical judgement. Participants will be contacted to determine their current antiplatelet therapy. This will be compared with their CYP2C19 genotype results to evaluate the proportion of new or revised prescriptions based on the CYP2C19 genotype result.

Sponsors

The University of Sydney
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Primary purpose
Prevention

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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.

Exclusion criteria

Participant who has previously obtained a pharmacogenomic test result. Unable to provide written informed consent, or consent through an authorised representative/guardian.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026