Ignite Creation Date:
2024-05-06 @ 3:25 AM
Last Modification Date:
2024-10-26 @ 11:33 AM
Study NCT ID:
NCT02287909
Status:
COMPLETED
Last Update Posted:
2020-09-16
First Post:
2014-11-06
Brief Title:
Switching From Ticagrelor to Clopidogrel in Patients With Coronary Artery Disease
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
Pharmacodynamic Evaluation of Switching From Ticagrelor to Clopidogrel in Patients With 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:
SWAP-4
Brief Summary:
The recommended antiplatelet treatment regimen for patients affected by acute coronary syndromes ACS and those undergoing percutaneous coronary intervention PCI consists in the combination of aspirin and a P2Y12 receptor inhibitor More potent P2Y12 receptor inhibitors such as ticagrelor have been developed which are associated with less response variability than clopidogrel and better clinical outcomes Ticagrelor use has increased significantly because of its more expanded Food and Drug Administration FDA indications compared with prasugrel However despite the evidence for sustained efficacy and safety many physicians limit treatment duration with ticagrelor to the early phases following an ACS mostly due to cost issues and concerns about increased bleeding Therefore it is very common in clinical practice to switch patients while on maintenance dosing MD with ticagrelor to treatment with clopidogrel However the pharmacodynamic PD effects of switching from ticagrelor to clopidogrel remain unknown Therefore the aim of this investigation is to evaluate the PD effects of switching from ticagrelor to clopidogrel
Detailed Description:
The recommended antiplatelet treatment regimen for patients affected by acute coronary syndromes ACS and those undergoing percutaneous coronary intervention PCI consists in the combination of aspirin and a P2Y12 receptor inhibitor Currently three P2Y12 receptor inhibitors are available for clinical use clopidogrel prasugrel and ticagrelor Among these clopidogrel remains the most widely used However recent studies have shown that there is a broad variability in platelet-inhibitory response induced by clopidogrel which in turn is associated with worse outcomes More potent P2Y12 receptor inhibitors prasugrel and ticagrelor have been developed which are associated with less response variability than clopidogrel and better clinical outcomes Ticagrelor use has increased significantly because of its more expanded Food and Drug Administration FDA indications compared with prasugrel However despite the evidence for sustained efficacy and safety many physicians limit treatment duration with ticagrelor to the early phases following an ACS early weeks or months rather than one-year mostly due to cost issues and concerns about increased bleeding Therefore it is very common in clinical practice to switch patients while on maintenance dosing MD with ticagrelor to treatment with clopidogrel However the pharmacodynamic PD effects of switching from ticagrelor to clopidogrel remain unknown In addition it is unknown whether switching from ticagrelor to clopidogrel should occur with or without a loading dose LD Therefore the aim of this investigation is to evaluate the PD effects of switching from ticagrelor to clopidogrel with and without a LD The present study has a prospective randomized open-label design in which patients will be treated with 4 different strategies to assess PD profiling after switching This study will provide important insights on PD effects of switching from ticagrelor to clopidogrel
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?:
True
Is an FDA AA801 Violation?:
None