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Active Not Recruiting
NCT06143709
Precision PCI Registry
Conditions: Coronary Artery Disease, Percutaneous Coronary Intervention
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 1643
Sponsor: University of Florida
Location: University of Florida Gainesville Florida
Summary
The feasibility and clinical benefit of using a patient's genotype to guide antiplatelet therapy prescribing has been demonstrated. However, a more precise understanding of who to genotype, what to include on a genetic testing panel, and how to change antiplatelet therapy based on genotype results and other patient-specific factors is needed to optimize the impact of genotype-guided antiplatelet therapy on patient outcomes.
The Precision PCI registry is a collaboration between the University of Florida, Gainesville and Jacksonville, USA, the University of North Carolina, Chapel Hill, USA, and University of Maryland, Baltimore, USA. This registry will include a diverse population of patients who undergo Percutaneous Coronary Intervention and clinical CYP2C19 genotyping, assess clinical outcomes over 12 months and collect DNA samples for additional genotyping, and conduct pharmacodynamic analysis of platelet function in a subset of patients.
Objectives of the study:
1. Define the influence of African ancestry and other patient-specific factors on clinical outcomes with genotype-guided antiplatelet therapy following PCI in a real-world setting
2. Evaluate the safety and effectiveness of genotype-guided de-escalation of antiplatelet therapy (i.e., switching to less potent antiplatelet therapy) after PCI in a real-world setting
3. Elucidate the effect(s) of genotypes beyond CYP2C19 on platelet reactivity and clinical outcomes with clopidogrel after PCI
Eligibility Criteria
Inclusion Criteria
* Age ≥18 years
* Underwent percutaneous coronary intervention for any indication
* Had clinical CYP2C19 genotyping
* Treated with dual antiplatelet therapy including clopidogrel, prasugrel, or ticagrelor plus aspirin or
* Treated with a combination of a P2Y12 inhibitor i.e. clopidogrel, prasugrel or ticagrelor plus an oral anticoagulant.
Exclusion Criteria:
* Managed surgically
* Treated with thrombolysis within 48 hours
Source: ClinicalTrials.gov (NCT06143709). StuddyBuddy aggregates publicly available trial information.