Ignite Creation Date:
2024-05-06 @ 11:18 AM
Last Modification Date:
2024-10-26 @ 12:43 PM
Study NCT ID:
NCT03489863
Status:
COMPLETED
Last Update Posted:
2020-09-16
First Post:
2018-03-21
Brief Title:
Prasugrel Versus Ticagrelor in Patients With CYP2C19 Loss-of-function a Validation Study
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
Pharmacodynamic Comparison of Prasugrel Versus Ticagrelor in Patients With CYP2C19 Loss-of-function Genotype a Validation Study in Patients With Stable Coronary Artery Disease
Status:
COMPLETED
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
Therapeutic inhibition of platelet activation is essential for the management of ischemic cardiovascular disease The use of platelet adenosine diphosphate ADP P2Y12 receptor antagonists clopidogrel prasugrel and ticagrelor in addition to aspirin are associated with a decrease in cardiovascular events in high-risk coronary artery disease CAD patients Clopidogrel is the most broadly utilized P2Y12 receptor antagonist However among clopidogrel treated patients there is broad variability in antiplatelet drug response which is known carry prognostic implications 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None