Ignite Creation Date:
2024-05-06 @ 4:26 PM
Last Modification Date:
2024-10-26 @ 2:10 PM
Study NCT ID:
NCT04981041
Status:
RECRUITING
Last Update Posted:
2023-07-14
First Post:
2021-07-21
Brief Title:
Escalated Single Platelet Inhibition for One Month Plus NOAC in Patients With Atrial Fibrillation and ACS Undergoing PCI
Sponsor:
Ludwig-Maximilians - University of Munich
Organization:
Ludwig-Maximilians - University of Munich
Study Overview
Official Title:
Escalated Single Platelet Inhibition for One Month Plus Direct Oral Anticoagulation in Patients With Atrial Fibrillation and acUte coRonary Syndrome Undergoing percutaneoUS Coronary Intervention
Status:
RECRUITING
Status Verified Date:
2023-07
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:
EPIDAURUS
Brief Summary:
The selection of the optimal antithrombotic therapy in patients with nonvalvular atrial fibrillation AF and acute coronary syndrome ACS undergoing percutaneous coronary intervention PCI is challenging Until recently triple antithrombotic therapy TAT consisting in Aspirin plus Clopidogrel plus OAC was considered the treatment of choice While efficiently preventing ischaemic events TAT is associated with an increase in bleeding complications Therefore in the past years several randomized controlled trials challenged TAT by comparing a triple antithrombotic therapy TAT regimen based on Vitamin K antagonists VKA to a dual antithrombotic regimen DAT based on non-vitamin K antagonist oral anticoagulants NOACs and P2Y12-inhibitors mainly Clopidogrel in patients with AF undergoing PCI
However approximately 30-40 of patients show low response to Clopidogrel and are not adequately protected against ischaemic events in particular when presenting with ACS This is supported by a recent meta-analysis reporting that TAT compared to DAT is associated with lower rates of stent thrombosis within 30 days after PCI It is therefore reasonable to assume that a more potent platelet inhibition within the first month after PCI might reduce the rate of ischaemic complications observed in AF patients undergoing PCI when receiving DAT Moreover a subsequent de-escalation to a less potent platelet inhibition one month after PCI might prevent an increase in bleeding complications
In EPIDAURUS the investigators will therefore test the hypothesis that DAT using NOAC plus an escalated antiplatelet therapy with a potent P2Y12-inhibitor for one month followed by Clopidogrel reduces ischaemic events without a relevant increase in bleeding complications in patients with AF and ACS undergoing PCI compared to standard DAT with NOAC plus Clopidogrel
However approximately 30-40 of patients show low response to Clopidogrel and are not adequately protected against ischaemic events in particular when presenting with ACS This is supported by a recent meta-analysis reporting that TAT compared to DAT is associated with lower rates of stent thrombosis within 30 days after PCI It is therefore reasonable to assume that a more potent platelet inhibition within the first month after PCI might reduce the rate of ischaemic complications observed in AF patients undergoing PCI when receiving DAT Moreover a subsequent de-escalation to a less potent platelet inhibition one month after PCI might prevent an increase in bleeding complications
In EPIDAURUS the investigators will therefore test the hypothesis that DAT using NOAC plus an escalated antiplatelet therapy with a potent P2Y12-inhibitor for one month followed by Clopidogrel reduces ischaemic events without a relevant increase in bleeding complications in patients with AF and ACS undergoing PCI compared to standard DAT with NOAC plus Clopidogrel
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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