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Implementing Precision Medicine Approaches to Guide Anti-platelet Selection

NCT04090281 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2021-09-28

No results posted yet for this study

Summary

The study aims to determine the feasibility and clinical utility of incorporating precision medicine approaches, incorporating both cytochrome P450 2C19 (CYP2C19) genotyping and platelet reactivity phenotyping, with standard of care for patients with acute coronary syndromes (ACS), post PCI.

Conditions

  • Acute Coronary Syndrome (ACS)
  • STEMI - ST Elevation Myocardial Infarction (MI)
  • NSTEMI - Non-ST Segment Elevation MI
  • Unstable Angina (UA)

Interventions

GENETIC

CYP2C19 genotyping

Upon hospital discharge, patients will undergo CYP2C19 genotyping to guide initial P2Y12 inhibitor selection. At 14 days, post discharge, patients will undergo on treatment platelet reactivity phenotyping to further guide deescalation of P2Y12 inhibitor therapy

Sponsors & Collaborators

  • University of Southern California

    lead OTHER

Principal Investigators

  • Scott A Mosley, PharmD · University of Southern California School of Pharmacy

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-13
Primary Completion
2023-05-31
Completion
2023-11-30
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04090281 on ClinicalTrials.gov