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NCT03489863 · ClinicalTrials.gov registry record · Phase 4

Prasugrel Versus Ticagrelor in Patients With CYP2C19 Loss-of-function: a Validation Study

A Phase 4 study of Coronary Artery Disease, sponsored by University of Florida.

Completed
Registry status
Phase 4
Development phase
14
Enrollment target
1
Study location

NCT03489863 is a Phase 4 study of Coronary Artery Disease that has completed, run by University of Florida. The registered enrollment target is 14 participants, below the 1,287-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03489863, a Phase 4 study of Coronary Artery Disease, has completed, sponsored by University of Florida.

COMPLETED
Registry status
Phase 4
Development phase
14 participants
Enrollment target
1
Study location

Study Summary

Polymorphisms of the cytochrome P450 (CYP) 2C19 enzyme has been consistently shown to modulate clopidogrel response. Accordingly, the Food and Drug Administration (FDA) has issued a warning on the potential for reduced efficacy of clopidogrel among carriers of loss-of-function alleles (LOF) for CYP2C19 and suggest considering alternative antiplatelet therapies for these individuals. The pharmacodynamic (PD) effects of prasugrel and ticagrelor are not affected by CYP2C19 genetic polymorphisms. However, to date there are no head-to-head PD comparisons between these agents among patients with different CYP2C19 genetic polymorphisms, which is currently under investigation in CAD patients undergoing PCI at UF Health-Jacksonville (UFJ 2014-12, NCT 02065479). In order to rule out play of chance findings, pharmacogenetic investigations require external validation cohorts to support the study findings. Therefore, the present randomized study is designed to serve as an external validation cohort conducted in patients with established CAD not undergoing PCI testing the non-inferiority in platelet reactivity of prasugrel versus ticagrelor among CYP2C19 LOF allele carriers.

Conditions Studied

Coronary Artery Disease

Interventions

  • DRUG Prasugrel
  • DRUG Ticagrelor

Study Locations (1)

Florida

  • University of Florida - Jacksonville

Trial Details

FieldValue
Enrollment Target 14 participants
Start Date 2018-05-30
Est. Completion 2019-03-20
Phase Phase 4

Sponsor

University of Florida

1,106 total trials

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What the Registry Record Tells You About NCT03489863

The ClinicalTrials.gov registry entry for NCT03489863 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,287-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (99% lower). The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Coronary Artery Disease appearing as the primary indexed condition, and to 2 interventions - of which Prasugrel is the first listed.

NCT03489863 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.

Frequently Asked Questions

What is clinical trial NCT03489863 about?

NCT03489863 is a clinical study titled "Prasugrel Versus Ticagrelor in Patients With CYP2C19 Loss-of-function: a Validation Study". Polymorphisms of the cytochrome P450 (CYP) 2C19 enzyme has been consistently shown to modulate clopidogrel response. Accordingly, the Food and Drug Administration (FDA) has issued a warning on the potential for reduced efficacy of clopidogrel among carriers of loss-of-function alleles (LOF) for CYP2...

What is the current status of trial NCT03489863?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 14 participants. The study started on 2018-05-30. Estimated completion is 2019-03-20.

What conditions does trial NCT03489863 study?

This clinical trial studies the following conditions: Coronary Artery Disease.

What interventions are being tested in trial NCT03489863?

The interventions under investigation include: Prasugrel (DRUG), Ticagrelor (DRUG).

Who is sponsoring clinical trial NCT03489863?

This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03489863 being conducted?

This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.