Atrial fibrillation and ischemic events with rivaroxaban in patients with stable coronary artery disease (AFIRE): Protocol for a multicenter, prospective, randomized, open-label, parallel group study

Satoshi Yasuda, Koichi Kaikita, Hisao Ogawa, Masaharu Akao, Junya Ako, Tetsuya Matoba, Masato Nakamura, Katsumi Miyauchi, Nobuhisa Hagiwara, Kazuo Kimura, Atsushi Hirayama, Kunihiko Matsui

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

Background: In atrial fibrillation (AF) patients with coronary artery disease (CAD), anticoagulants are commonly used in combination with antiplatelet drugs. However, dual therapy can increase the risk of bleeding, and the potential therapeutic benefits must be weighed against this. Therefore, it is recommended that dual therapy is only used for a limited time, and that monotherapy with anticoagulants should start from 1 year after percutaneous coronary intervention (PCI). However, there is a lack of evidence on the use of monotherapy, in particular with direct oral anticoagulants, in this group of patients. Methods: The AFIRE Study is a multicenter, prospective, randomized, open-label, parallel group study conducted in patients aged ≥20 years with non-valvular AF (NVAF) and CAD. Patients who have undergone PCI or coronary artery bypass graft at least 1 year prior to enrollment, or those without significant coronary lesions requiring PCI (≥50% stenosis), will be included. Approximately 2200 participants will be randomized to receive either rivaroxaban monotherapy or rivaroxaban plus an antiplatelet drug (aspirin, clopidogrel, or prasugrel). The primary efficacy endpoints are the composite of cardiovascular events (stroke, non-central nervous system embolism, myocardial infarction, and unstable angina pectoris requiring revascularizations) and all-cause mortality. The primary safety endpoint is major bleeding as defined by the International Society on Thrombosis and Haemostasis criteria. Conclusions: This study will be the first to assess the efficacy and safety of rivaroxaban monotherapy in NVAF patients with stable CAD.

Original languageEnglish
Pages (from-to)108-112
Number of pages5
JournalInternational Journal of Cardiology
Volume265
DOIs
Publication statusPublished - Aug 15 2018

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Atrial Fibrillation
Coronary Artery Disease
Percutaneous Coronary Intervention
Anticoagulants
clopidogrel
Platelet Aggregation Inhibitors
Myocardial Infarction
Hemorrhage
Safety
Unstable Angina
Embolism
Hemostasis
Coronary Artery Bypass
Nervous System
Aspirin
Pathologic Constriction
Thrombosis
Therapeutics
Rivaroxaban
Transplants

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

Atrial fibrillation and ischemic events with rivaroxaban in patients with stable coronary artery disease (AFIRE) : Protocol for a multicenter, prospective, randomized, open-label, parallel group study. / Yasuda, Satoshi; Kaikita, Koichi; Ogawa, Hisao; Akao, Masaharu; Ako, Junya; Matoba, Tetsuya; Nakamura, Masato; Miyauchi, Katsumi; Hagiwara, Nobuhisa; Kimura, Kazuo; Hirayama, Atsushi; Matsui, Kunihiko.

In: International Journal of Cardiology, Vol. 265, 15.08.2018, p. 108-112.

Research output: Contribution to journalArticle

Yasuda, Satoshi ; Kaikita, Koichi ; Ogawa, Hisao ; Akao, Masaharu ; Ako, Junya ; Matoba, Tetsuya ; Nakamura, Masato ; Miyauchi, Katsumi ; Hagiwara, Nobuhisa ; Kimura, Kazuo ; Hirayama, Atsushi ; Matsui, Kunihiko. / Atrial fibrillation and ischemic events with rivaroxaban in patients with stable coronary artery disease (AFIRE) : Protocol for a multicenter, prospective, randomized, open-label, parallel group study. In: International Journal of Cardiology. 2018 ; Vol. 265. pp. 108-112.
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T1 - Atrial fibrillation and ischemic events with rivaroxaban in patients with stable coronary artery disease (AFIRE)

T2 - Protocol for a multicenter, prospective, randomized, open-label, parallel group study

AU - Yasuda, Satoshi

AU - Kaikita, Koichi

AU - Ogawa, Hisao

AU - Akao, Masaharu

AU - Ako, Junya

AU - Matoba, Tetsuya

AU - Nakamura, Masato

AU - Miyauchi, Katsumi

AU - Hagiwara, Nobuhisa

AU - Kimura, Kazuo

AU - Hirayama, Atsushi

AU - Matsui, Kunihiko

PY - 2018/8/15

Y1 - 2018/8/15

N2 - Background: In atrial fibrillation (AF) patients with coronary artery disease (CAD), anticoagulants are commonly used in combination with antiplatelet drugs. However, dual therapy can increase the risk of bleeding, and the potential therapeutic benefits must be weighed against this. Therefore, it is recommended that dual therapy is only used for a limited time, and that monotherapy with anticoagulants should start from 1 year after percutaneous coronary intervention (PCI). However, there is a lack of evidence on the use of monotherapy, in particular with direct oral anticoagulants, in this group of patients. Methods: The AFIRE Study is a multicenter, prospective, randomized, open-label, parallel group study conducted in patients aged ≥20 years with non-valvular AF (NVAF) and CAD. Patients who have undergone PCI or coronary artery bypass graft at least 1 year prior to enrollment, or those without significant coronary lesions requiring PCI (≥50% stenosis), will be included. Approximately 2200 participants will be randomized to receive either rivaroxaban monotherapy or rivaroxaban plus an antiplatelet drug (aspirin, clopidogrel, or prasugrel). The primary efficacy endpoints are the composite of cardiovascular events (stroke, non-central nervous system embolism, myocardial infarction, and unstable angina pectoris requiring revascularizations) and all-cause mortality. The primary safety endpoint is major bleeding as defined by the International Society on Thrombosis and Haemostasis criteria. Conclusions: This study will be the first to assess the efficacy and safety of rivaroxaban monotherapy in NVAF patients with stable CAD.

AB - Background: In atrial fibrillation (AF) patients with coronary artery disease (CAD), anticoagulants are commonly used in combination with antiplatelet drugs. However, dual therapy can increase the risk of bleeding, and the potential therapeutic benefits must be weighed against this. Therefore, it is recommended that dual therapy is only used for a limited time, and that monotherapy with anticoagulants should start from 1 year after percutaneous coronary intervention (PCI). However, there is a lack of evidence on the use of monotherapy, in particular with direct oral anticoagulants, in this group of patients. Methods: The AFIRE Study is a multicenter, prospective, randomized, open-label, parallel group study conducted in patients aged ≥20 years with non-valvular AF (NVAF) and CAD. Patients who have undergone PCI or coronary artery bypass graft at least 1 year prior to enrollment, or those without significant coronary lesions requiring PCI (≥50% stenosis), will be included. Approximately 2200 participants will be randomized to receive either rivaroxaban monotherapy or rivaroxaban plus an antiplatelet drug (aspirin, clopidogrel, or prasugrel). The primary efficacy endpoints are the composite of cardiovascular events (stroke, non-central nervous system embolism, myocardial infarction, and unstable angina pectoris requiring revascularizations) and all-cause mortality. The primary safety endpoint is major bleeding as defined by the International Society on Thrombosis and Haemostasis criteria. Conclusions: This study will be the first to assess the efficacy and safety of rivaroxaban monotherapy in NVAF patients with stable CAD.

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