Atrial Fibrillation and Ischemic Events With Rivaroxaban in Patients With Stable Coronary Artery Disease Study
Atrial Fibrillation and Ischemic Events With Rivaroxaban in Patients With Stable Coronary Artery Disease Study
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).
Study Design:prospective, randomized, open-label trial

 Allocation:ratio to rivaroxaban monotherapy and rivaroxaban in co-administration with a
 single anti-platelet therapy is 1: 1 using WEB system
Inclusion Criteria:

 Patients with non-valvular atrial fibrillation complicated with stable coronary artery
 disease who are 20 years or older, with CHADS2 score are ≧1 , and that fulfill one of the
 following criteria and can provide written consent for participation in the present study
 will be eligible.

 1. Patients who underwent percutaneous coronary intervention(PCI), including plain old
 balloon angioplasty(POBA), at least one year ago

 2. Patients who have coronary stenosis requiring no percutaneous coronary intervention
 (50% or more stenosis) as indicated by coronary CT or coronary angiography(CAG)

 3. Patients who underwent coronary artery bypass graft (CABG) at least one year ago

 Exclusion Criteria:

 -  Patients for whom rivaroxaban is contraindicated

 -  Patients for whom aspirin, thienopyridine derivatives (clopidogrel or prasugrel) are
 contraindicated

 -  Patients who underwent PCI, including POBA, in the past one year

 -  Patients who are going to undergo revascularization

 -  Patients who have a past history of stent thrombosis

 -  Those who are going to undergo invasive surgery (excluding digestive endoscopy and
 biopsy)

 -  Patients who have active tumors

 -  Patients who have poorly-controlled hypertension (systolic blood pressure at hospital
 admission: 160 mmHg or more)

 -  Patients who cannot discontinue treatment with antiplatelet drugs (the physician in
 charge will make a decision on the basis of the lesion shape, lesion site and type of
 stents.)

 -  Patients judged as inappropriate for this study by investigators