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NCT02724319 · ClinicalTrials.gov registry record
Implementation of CYP2C19 Genotyping to Guide Antiplatelet Therapy
A clinical trial of Coronary Artery Disease, sponsored by University of Florida.
- Completed
- Registry status
- 1,000
- Enrollment target
- 1
- Study location
NCT02724319 is a study of Coronary Artery Disease that has completed, run by University of Florida. The registered enrollment target is 1,000 participants, below the 1,282-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (22% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02724319, a study of Coronary Artery Disease, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- 1,000 participants
- Enrollment target
- 1
- Study location
Study Summary
It is well established that clopidogrel-induced antiplatelet effects is suboptimal in many patients who are thus exposed to an increased risk of adverse cardiovascular events. Studies have shown that genotypes of the cytochrome P450 (CYP) 2C19 enzyme, which is a key determinant of clopidogrel metabolism, contribute to these findings. Prasugrel and ticagrelor are alternative agents whose effectiveness is not dependent on CYP2C19 genotype. A boxed warning on the Food and Drug Administration (FDA)-approved clopidogrel labeling warns of reduced effectiveness in patients with the LOF genotype and recommends alternative therapies in these patients. The availability of an assay recently approved by the FDA, SpartanRX, which provides results within one-hour facilitates performing genetic testing as a clinical test in real-world practice. We therefore propose to 1) examine the feasibility of implementing CYP2C19 genotyping using SpartanRX as standard of care for patients undergoing cardiac catheterization at UF Health Jacksonville providing the opportunity for clinicians to embrace genotype-guided antiplatelet therapy in those who proceed to PCI and 2) determine if CYP2C19 genotype-guided antiplatelet therapy reduces the risk for major adverse cardiovascular outcomes after PCI.
Conditions Studied
Interventions
- DEVICE SpartanRX
Study Locations (1)
Florida
- University of Florida - Jacksonville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,000 participants |
| Start Date | 2016-05 |
| Est. Completion | 2021-12-31 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02724319
The ClinicalTrials.gov registry entry for NCT02724319 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 1,000 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,282-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (22% 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 1 intervention - of which SpartanRX is the first listed.
NCT02724319 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.
Frequently Asked Questions
What is clinical trial NCT02724319 about?
NCT02724319 is a clinical study titled "Implementation of CYP2C19 Genotyping to Guide Antiplatelet Therapy". It is well established that clopidogrel-induced antiplatelet effects is suboptimal in many patients who are thus exposed to an increased risk of adverse cardiovascular events. Studies have shown that genotypes of the cytochrome P450 (CYP) 2C19 enzyme, which is a key determinant of clopidogrel metabo...
What is the current status of trial NCT02724319?
This trial is currently completed. The enrollment target is 1,000 participants. The study started on 2016-05. Estimated completion is 2021-12-31.
What conditions does trial NCT02724319 study?
This clinical trial studies the following conditions: Coronary Artery Disease.
What interventions are being tested in trial NCT02724319?
The interventions under investigation include: SpartanRX (DEVICE).
Who is sponsoring clinical trial NCT02724319?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02724319 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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Read our methodology - how this data is sourced, computed, and verified.
Related
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