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.
Abstract | BACKGROUND: 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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Authors | Satoshi Yasuda, Koichi Kaikita, Hisao Ogawa, Masaharu Akao, Junya Ako, Tetsuya Matoba, Masato Nakamura, Katsumi Miyauchi, Nobuhisa Hagiwara, Kazuo Kimura, Atsushi Hirayama, Kunihiko Matsui |
Journal | International journal of cardiology
(Int J Cardiol)
Vol. 265
Pg. 108-112
(Aug 15 2018)
ISSN: 1874-1754 [Electronic] Netherlands |
PMID | 29764706
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)
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Copyright | Copyright © 2018. Published by Elsevier B.V. |
Chemical References |
- Factor Xa Inhibitors
- Platelet Aggregation Inhibitors
- Rivaroxaban
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Topics |
- Atrial Fibrillation
(blood, diagnosis, drug therapy)
- Coronary Artery Disease
(blood, diagnosis, drug therapy)
- Drug Therapy, Combination
- Factor Xa Inhibitors
(administration & dosage, blood)
- Female
- Hemorrhage
(chemically induced, diagnosis)
- Humans
- Male
- Myocardial Ischemia
(blood, diagnosis, drug therapy)
- Platelet Aggregation Inhibitors
(administration & dosage, blood)
- Prospective Studies
- Rivaroxaban
(administration & dosage, adverse effects, blood)
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