Atrial Fibrillation and Ischemic Events With Rivaroxaban in Patients With Stable Coronary Artery Disease Study
Status:
Unknown status
Trial end date:
2017-12-01
Target enrollment:
Participant gender:
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).