Precision PCI Registry

NCT06143709 | Active Not Recruiting

• 2 other identifiers: IRB202000721R01HL149752
• Study Type: observational
• Target: 1,643
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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. 3.Elucidate the effect(s) of genotypes beyond CYP2C19 on platelet reactivity and clinical outcomes with clopidogrel after PCI

Conditions

Percutaneous Coronary Intervention; Coronary Artery Disease

Keywords

CYP2C19 Genotype; Percutaneous coronary intervention; Clopidogrel; Plavix

Outcome Measures

Primary Outcomes (1)

• Major atherothrombotic events

  Composite of death, myocardial infarction, ischemic stroke, stent thrombosis, and revascularization for unstable angina

  12 months

Secondary Outcomes (9)

• Net clinical benefit

  12 months

• Major adverse cardiovascular events

  12 months

• Clinically significant bleeding

  12 months

• All cause death

  12 months

• Cardiovascular death

  12 months

Study Arms (1)

Precision PCI Prospective Cohort

Patients who have undergone PCI and clinical CYP2C19 genotyping

Other: DNA sample collection

Interventions

DNA sample collection OTHER

Patients will be asked to provide a blood or mouth wash sample for DNA extraction

Precision PCI Prospective Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The target patient population will be male or female adults (age 18 years), of any race or ethnicity, who undergo PCI and clinical CYP2C19 genotyping, and are treated with clopidogrel, prasugrel, or ticagrelor in addition to aspirin.

You may qualify if:

• 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.

You may not qualify if:

• Managed surgically
• Treated with thrombolysis within 48 hours

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: collaborator
• University of Florida: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• University of Maryland, Baltimore: collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32609, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood and mouth wash will be collected from a subset of patients

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2023
• First Posted: November 22, 2023
• Study Start: July 17, 2020
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: De-identified genomic and phenotype data to be made available by depositing these data in dbGaP as soon as possible but no later than within one year of the completion of the funded project period or upon acceptance of the data for publication.
• Access Criteria: Data will be available as controlled-access data through dbGaP, in which interested users must submit a Data Use Certification to an appropriate NIH Data Access Committee for approval.

Locations

US (1)