Ignite Creation Date:
2024-05-06 @ 7:59 AM
Last Modification Date:
2024-10-26 @ 11:54 AM
Study NCT ID:
NCT02642419
Status:
UNKNOWN
Last Update Posted:
2015-12-30
First Post:
2015-10-21
Brief Title:
Atrial Fibrillation and Ischemic Events With Rivaroxaban in Patients With Stable Coronary Artery Disease Study
Sponsor:
Japan Cardiovascular Research Foundation
Organization:
Japan Cardiovascular Research Foundation
Study Overview
Official Title:
Atrial Fibrillation and Ischemic Events With Rivaroxaban in Patients With Stable Coronary Artery Disease Study AFIRE Study
Status:
UNKNOWN
Status Verified Date:
2015-12
Last Known Status:
RECRUITING
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:
AFIRE
Brief Summary:
In patients with atrial fibrillation AF complicated with coronary artery disease CAD antiplatelet drugs are commonly used for the prevention of recurrence of stent thrombosis and cardiovascular events in combination with anticoagulant drugs Based on the observations that the incidence of hemorrhagic complications increased when an antiplatelet drug was administered in combination with vitamin K antagonist VKA the guidelines for antithrombotic therapy after PCI in the US and EU recommend that DAPT dual anti-platelets therapy should be used in AF-complicated CAD patients for as short a time as possible following single anti-platelet and VKA and that monotherapy with VKA should be started from one year after PCI In 2013 the European Heart Rhythm Association EHRA published the guidelines for the use of NOACs in NVAF patients which state that NOACs may have advantage to VKAs in terms of anti-thrombotic effects in NVAF patients undergoing PCI However no clinical evidence has ever been generated to reveal the efficacy and safety of mono-drug therapy with a NOACs in stable CAD patients one year or more after PCI
AFIRE study is planned to evaluate the efficacy and safety of mono-drug therapy with a rivaroxaban in stable CAD patients Among NOACs rivaroxaban was chosen because of the evidence in Japanese patients and the results of a sub-analysis of ROCKET AF suggesting that rivaroxaban is more effective than VKA in reducing the incidence of myocardial infarction MI
AFIRE study is planned to evaluate the efficacy and safety of mono-drug therapy with a rivaroxaban in stable CAD patients Among NOACs rivaroxaban was chosen because of the evidence in Japanese patients and the results of a sub-analysis of ROCKET AF suggesting that rivaroxaban is more effective than VKA in reducing the incidence of myocardial infarction MI
Detailed Description:
Study Designprospective randomized open-label trial
Allocationratio to rivaroxaban monotherapy and rivaroxaban in co-administration with a single anti-platelet therapy is 1 1 using WEB system
Allocationratio to rivaroxaban monotherapy and rivaroxaban in co-administration with a single anti-platelet therapy is 1 1 using WEB system
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