Ignite Creation Date:
2024-05-06 @ 7:34 AM
Last Modification Date:
2024-10-26 @ 11:50 AM
Study NCT ID:
NCT02567461
Status:
COMPLETED
Last Update Posted:
2018-04-06
First Post:
2015-10-01
Brief Title:
Edoxaban in Patients With Coronary Artery Disease on Dual Antiplatelet Therapy With Aspirin and Clopidogrel
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
Effects of Edoxaban on the Cellular and Protein Phase of Coagulation in Patients With Coronary Artery Disease on Dual Antiplatelet Therapy With Aspirin and Clopidogrel EDOX-APT A Prospective Randomized Study
Status:
COMPLETED
Status Verified Date:
2018-04
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:
EDOX-APT
Brief Summary:
It is not uncommon that patients requiring dual antiplatelet therapy DAPT also need to be treated with oral anticoagulant therapy such as those with atrial fibrillation AF Warfarin and clopidogrel are still the most widely utilized oral anticoagulant and P2Y12 receptor inhibitor respectively However over the past years several non-vitamin K antagonist oral anticoagulants including edoxaban have been studied in the setting of AF showing encouraging safety and efficacy profiles as compared with warfarin However the effects of edoxaban in combination with DAPT in the setting of patients with coronary artery disease CAD are unexplored Moreover the role of edoxaban as part of a dual antithrombotic treatment strategy including clopidogrel and stopping aspirin represents another important area of clinical interest This investigation is a prospective randomized parallel-design open label pharmacodynamic study conducted in patients with CAD on DAPT with aspirin and clopidogrel testing two different edoxaban dosing regimens in addition to DAPT with aspirin and clopidogrel as well as in combination with clopidogrel only after stopping aspirin
Detailed Description:
Dual antiplatelet therapy DAPT with aspirin and a P2Y12 receptor antagonist is pivotal for the treatment of patients with coronary artery disease CAD undergoing percutaneous coronary intervention PCI and in patents following an acute coronary syndrome ACS Importantly it is not uncommon that patients requiring DAPT also need to be treated with oral anticoagulant therapy such as those with atrial fibrillation AF Warfarin and clopidogrel are still the most widely utilized oral anticoagulant and P2Y12 receptor inhibitor respectively However this treatment regimen has shown to be associated with an increased risk of bleeding as well as ischemic complications Over the past years several non-vitamin K antagonist oral anticoagulants NOACs including edoxaban have been studied in the setting of AF showing encouraging safety and efficacy profiles as compared with warfarin In the phase III ENGAGE AF-TIMI 48 trial edoxaban 60mg or 30mg oncedaily was non-inferior to warfarin with respect to the prevention of stroke or systemic embolism and was associated with significantly lower rates of bleeding and death from cardiovascular causes in patients with AF However the effects of edoxaban in combination with DAPT in the setting of patients with CAD are unexplored This may indeed represent a limitation for the uptake of edoxaban in modern day clinical practice where 10 of patients with AF also have CAD requiring PCI and thus may require triple antithrombotic therapy Moreover the role of edoxaban as part of a dual antithrombotic treatment strategy including clopidogrel and stopping aspirin represents another important area of clinical interest as it has the potential reduce the risk of bleeding while preserving protection from ischemic events This investigation is a prospective randomized parallel-design open label pharmacodynamic study conducted in patients with CAD on DAPT with aspirin and clopidogrel testing two different edoxaban dosing regimens 60mg or 30mg oncedaily in addition to DAPT with aspirin and clopidogrel as well as in combination with clopidogrel only after stopping aspirin
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?:
None
Is an FDA AA801 Violation?:
None