Ignite Creation Date:
2024-05-06 @ 8:38 AM
Last Modification Date:
2024-10-26 @ 12:03 PM
Study NCT ID:
NCT02789917
Status:
COMPLETED
Last Update Posted:
2020-08-14
First Post:
2016-05-24
Brief Title:
APixaban vs PhenpRocoumon in Patients With ACS and AF APPROACH-ACS-AF
Sponsor:
LMU Klinikum
Organization:
LMU Klinikum
Study Overview
Official Title:
APixaban Versus PhenpRocoumon Oral AntiCoagulation Plus Antiplatelet tHerapy in Patients With Acute Coronary Syndrome and Atrial Fibrillation
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:
APPROACH
Brief Summary:
It is hypothesised that a dual therapy strategy by oral anticoagulation with the new Factor-Xa-inhibitor apixaban plus clopidogrel is superior to a triple therapy regimen with phenprocoumon plus acetylsalicylic acid ASA and clopidogrel with respect to avoiding bleeding events in patients with atrial fibrillation undergoing percutaneous coronary intervention in the setting of an acute coronary syndrome
Detailed Description:
Patients with atrial fibrillation AF presenting an acute coronary syndrome ACS and undergoing PCI require a triple therapy with a combination of oral anticoagulation OAC and dual anti-platelet therapy Current guidelines recommend a regimen consisting of aspirin clopidogrel and an oral anticoagulant Although effective in preventing recurrent ischemia triple therapy confers an elevated bleeding risk which also has a major impact on the patients prognosis and survival Data from one randomized trial suggest that omitting aspirin in patients with indication for triple therapy may reduce the risk of bleeding without an increase of the rate of ischemic events In addition the recently introduced non-vitamin-K oral anticoagulants NOACs show less bleeding events as compared to vitamin-K antagonist in AF patients In this trial it is postulated that a dual therapy consisting of the factor-Xa inhibitor apixaban and clopidogrel is associated with significant lower bleeding rates as compared to traditional triple therapy with aspirin clopidogrel and a vitamin K antagonist VKA To test this hypothesis patients with atrial fibrillation who underwent PCI in the setting of an ACS will be randomized to either a dual therapy apixabanclopidogrel or a triple therapy aspirinclopiodgrelVKA The patients will be followed-up for 6 months after randomization
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