NCT02508116

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
509

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2014

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 24, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

November 7, 2018

Completed
Last Updated

November 7, 2018

Status Verified

October 1, 2018

Enrollment Period

2.5 years

First QC Date

July 21, 2015

Results QC Date

September 7, 2018

Last Update Submit

October 11, 2018

Conditions

Acute Coronary SyndromeCardiovascular Diseases

Keywords

pharmacogeneticsclopidogrelgenotype

Outcome Measures

Primary Outcomes (1)

  • The Number (Percentage) of Participants Receiving Prasugrel/Ticagrelor

    The number (percentage) of participants receiving prasugrel/ticagrelor in each randomized arm

    for up to 7 days after PCI

Secondary Outcomes (3)

  • Number of Participants With Drug Orders in Agreement With the Genotype-guided Recommendations

    for up to 7 days after PCI

  • Number of Participants With Major Cardiac Events

    1 year

  • Number of Participants With Bleeding Events

    1 year

Study Arms (2)

CYP2C19 Genotype guided

EXPERIMENTAL

Prospective CYP2C19 genotyping to decide antiplatelet therapy.

Genetic: CYP2C19 genotyping

Control group

NO INTERVENTION

Antiplatelet therapy will be decided based on usual care

Interventions

CYP2C19 genotypingGENETIC

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

Also known as: SpartanRx
CYP2C19 Genotype guided

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female subjects, ≥18 to ≤80 years at time of study
  • Status post PCI with stent implantation requiring antiplatelet therapy
  • Willingness to comply with all study-related procedures

You may not qualify if:

  • Pending imminent surgery placing patients at increased risk for bleeding with prasugrel or ticagrelor.
  • History of intracranial hemorrhage, TIA, and stroke
  • Active bleeding
  • Need for long-term anticoagulation (i.e. warfarin, dabigatran, rivaroxaban, apixaban, edoxaban, or lovenox).
  • Current or prior (within the past four weeks) treatment with voraxapar (Zontivity).
  • Severe renal or hepatic impairment
  • Treating physician does not want subject to participate
  • Drug allergy to clopidogrel, prasugrel or ticagrelor.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • Tuteja S, Glick H, Matthai W, Nachamkin I, Nathan A, Monono K, Carcuffe C, Maslowski K, Chang G, Kobayashi T, Anwaruddin S, Hirshfeld J, Wilensky RL, Herrmann HC, Kolansky DM, Rader DJ, Giri J. Prospective CYP2C19 Genotyping to Guide Antiplatelet Therapy Following Percutaneous Coronary Intervention: A Pragmatic Randomized Clinical Trial. Circ Genom Precis Med. 2020 Feb;13(1):e002640. doi: 10.1161/CIRCGEN.119.002640. Epub 2020 Jan 12.

    PMID: 31928229DERIVED

MeSH Terms

Conditions

Acute Coronary SyndromeCardiovascular Diseases

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesVascular Diseases

Results Point of Contact

Title
Sony Tuteja, PharmD, MS
Organization
University of Pennsylvania School of Medicine
sonyt@pennmedicine.upenn.edu
215-573-7834

Study Officials

  • Sony Tuteja, PharmD, MS

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

  • Jay S Giri, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Patients undergoing PCI are randomized to genotype guided antiplatelet therapy vs. usual care.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Associate

Study Record Dates

First Submitted

July 21, 2015

First Posted

July 24, 2015

Study Start

November 1, 2014

Primary Completion

May 1, 2017

Study Completion

August 1, 2017

Last Updated

November 7, 2018

Results First Posted

November 7, 2018

Record last verified: 2018-10

Locations

US(2)