Ignite Creation Date:
2024-05-06 @ 2:18 AM
Last Modification Date:
2024-10-26 @ 11:16 AM
Study NCT ID:
NCT02016170
Status:
COMPLETED
Last Update Posted:
2024-07-03
First Post:
2013-12-13
Brief Title:
Pharmacodynamic Evaluation of Switching From Prasugrel to Ticagrelor
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
Pharmacodynamic Evaluation of Switching From Prasugrel to Ticagrelor The SWAP SWitching Anti Platelet-3 Study
Status:
COMPLETED
Status Verified Date:
2024-06
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:
SWAP3
Brief Summary:
Recently two new oral P2Y12 antagonists have been approved for clinical use prasugrel a third generation thienopyridine and ticagrelor a first in class cyclopentyltriazolopyrimidine CPTP These agents have been shown to be associated with more potent platelet inhibitory effects compared with clopidogrel In addition both agents have shown to be superior to clopidogrel in preventing recurrent ischemic events in the setting of acute coronary syndromes ACS Understanding how to switch patients from prasugrel to ticagrelor is an unmet need of clinical interest The proposed PD investigation will have a prospective randomized parallel design aimed to show that switching patients from prasugrel to ticagrelor provides similar levels of platelet inhibition
Detailed Description:
Dual antiplatelet therapy consisting of aspirin and a P2Y12 receptor antagonist is the cornerstone of treatment for secondary prevention of thrombotic events in patients with coronary artery disease Recently two new oral P2Y12 antagonists have been approved for clinical use prasugrel a third generation thienopyridine and ticagrelor a first in class cyclopentyltriazolopyrimidine CPTP These agents have been shown to be associated with more potent platelet inhibitory effects compared with clopidogrel In addition both agents have shown to be superior to clopidogrel in preventing recurrent ischemic events in the setting of acute coronary syndromes ACS Therefore current guidelines recommend prasugrel or ticagrelor as first line therapy according to European Society of Cardiology in ACS patients undergoing percutaneous coronary intervention PCI Despite the broader indication for ticagrelor also medically managed ACS and its mortality benefit prasugrel has a higher uptake than ticagrelor in the US market likely due to its earlier approval Further implementation of prasugrel into institutional protocols particularly for ST elevation myocardial infarction STEMI patients undergoing primary PCI may also be a reason for the slow uptake of ticagrelor However many clinicians would indeed consider ticagrelor as the long-term treatment of choice for a variety of reasons Therefore understanding how to switch patients from prasugrel to ticagrelor is an unmet need of clinical interest However currently there are no data on the pharmacodynamic PD effects of switching from prasugrel to ticagrelor The proposed PD investigation will have a prospective randomized parallel design aimed to show that switching patients from prasugrel to ticagrelor provides similar levels of platelet inhibition This study will provide insights on the PD effects of switching and will help clinicians to choose the most appropriate schema to avoid complications related to inadequate antiplatelet therapy in patients with coronary artery disease if switching from prasugrel to ticagrelor is desired
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None