Rivaroxaban versus warfarin in Japanese patients with atrial fibrillation
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- Hori Masatsugu
- Osaka Medical Center for Cancer and Cardiovascular Diseases
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- Matsumoto Masayasu
- Department of Clinical Neuroscience and Therapeutics, Hiroshima University
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- Tanahashi Norio
- Department of Neurology, Saitama Medical University International Medical Center
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- Momomura Shin-ichi
- Division of Cardiovascular Medicine, Saitama Medical Center, Jichi Medical University
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- Uchiyama Shinichiro
- Department of Neurology, Tokyo Women’s Medical University
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- Goto Shinya
- Department of Medicine (Cardiology), Tokai University School of Medicine
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- Izumi Tohru
- Department of Cardio-angiology, Kitasato University School of Medicine
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- Koretsune Yukihiro
- Institute for Clinical Research, Osaka National Hospital
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- Kajikawa Mariko
- Bayer Yakuhin Ltd
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- Kato Masaharu
- Bayer Yakuhin Ltd
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- Ueda Hitoshi
- Bayer Yakuhin Ltd
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- Iwamoto Kazuya
- Bayer Yakuhin Ltd
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- Tajiri Masahiro
- Bayer Yakuhin Ltd
書誌事項
- タイトル別名
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- Rivaroxaban vs. Warfarin in Japanese Patients With Atrial Fibrillation
- Rivaroxaban vs. warfarin in Japanese patients with atrial fibrillation – the J-ROCKET AF study
- Rivaroxaban vs. warfarin in Japanese patients with atrial fibrillation—the J-ROCKET AF study
- – The J-ROCKET AF Study –
この論文をさがす
抄録
Background: The global ROCKET AF study evaluated once-daily rivaroxaban vs. warfarin for stroke and systemic embolism prevention in patients with atrial fibrillation (AF). A separate trial, J-ROCKET AF, compared the safety of a Japan-specific rivaroxaban dose with warfarin administered according to Japanese guidelines in Japanese patients with AF. Methods and Results: J-ROCKET AF was a prospective, randomized, double-blind, phase III trial. Patients (n=1,280) with non-valvular AF at increased risk for stroke were randomized to receive 15mg once-daily rivaroxaban or warfarin dose-adjusted according to Japanese guidelines. The primary objective was to determine non-inferiority of rivaroxaban against warfarin for the principal safety outcome of major and non-major clinically relevant bleeding, in the on-treatment safety population. The primary efficacy endpoint was the composite of stroke and systemic embolism. Non-inferiority of rivaroxaban to warfarin was confirmed; the rate of the principal safety outcome was 18.04% per year in rivaroxaban-treated patients and 16.42% per year in warfarin-treated patients (hazard ratio [HR] 1.11; 95% confidence interval 0.87–1.42; P<0.001 [non-inferiority]). Intracranial hemorrhage rates were 0.8% with rivaroxaban and 1.6% with warfarin. There was a strong trend for a reduction in the rate of stroke/systemic embolism with rivaroxaban vs. warfarin (HR, 0.49; P=0.050). Conclusions: J-ROCKET AF demonstrated the safety of a Japan-specific rivaroxaban dose and supports bridging the global ROCKET AF results into Japanese clinical practice. (Circ J 2012; 76: 2104–2111)<br>
収録刊行物
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- Circulation Journal
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Circulation Journal 76 (9), 2104-2111, 2012
一般社団法人 日本循環器学会
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詳細情報 詳細情報について
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- CRID
- 1390282680079428224
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- NII論文ID
- 10030696394
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- NII書誌ID
- AA11591968
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- COI
- 1:CAS:528:DC%2BC38XhtlOmsrrE
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- ISSN
- 13474820
- 13469843
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- PubMed
- 22664783
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- 本文言語コード
- en
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- データソース種別
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- JaLC
- Crossref
- PubMed
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