MedTrace Logo

Assessment of Prospective CYP2C19 Genotype Guided Dosing of Anti-Platelet Therapy in Percutaneous Coronary Intervention

NCT02508116 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 509

Last updated 2018-11-07

Study results available
· View outcomes & findings →

Summary

This is a randomized, prospective, open label study to determine the cost-effectiveness of genotype-guided antiplatelet therapy. Patients undergoing percutaneous intervention (PCI) with stent implantation, will be randomized either to genotype guided dosing of antiplatelet therapy or usual care. The study utilizes a novel genotyping device, SpartanRx, to determine CYP2C19 genotypes from a buccal swab sample with 1 hour turnaround time.

Conditions

Interventions

GENETIC

CYP2C19 genotyping

The study utilizes a genotyping device, SpartanRx™ (Spartan Bioscience, Ottawa, Canada) that provides identification of a patient's CYP2C19 \*2, \*3, and \*17 genotypes determined from genomic DNA from a buccal swab sample with 1 hour turnaround time

Sponsors & Collaborators

Principal Investigators

  • Sony Tuteja, PharmD, MS · University of Pennsylvania

  • Jay S Giri, MD · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2017-05-31
Completion
2017-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT02508116 on ClinicalTrials.gov