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NCT06143709 · ClinicalTrials.gov record · last posted 2026-08-18

Precision PCI Registry

StatusActive, Not Recruiting
PhaseNot specified
Started2020-07-17
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from the ClinicalTrials.gov record
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

Protocol amendment history 2 changes detected by DataLookout

2026-08-19
critical
Primary completion pushed: 2026-07-01 → 2027-06-30
2026-08-19
minor
Completion pushed: 2026-07-01 → 2027-06-30
Trial Details
NCT Number NCT06143709
Lead Sponsor University of Florida
Collaborators: University of North Carolina, Chapel Hill, National Heart, Lung, and Blood Institute (NHLBI), University of Maryland, Baltimore
Conditions Coronary Artery Disease, Percutaneous Coronary Intervention
Enrollment 1,643 participants
Start Date 2020-07-17
Primary Completion 2027-06-30 (estimated)
Study Completion 2027-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-18