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Rivaroxaban vs. Warfarin in Japanese Patients With Atrial Fibrillation: – The J-ROCKET AF Study –

Open access
Hori, Masatsugu, Matsumoto, Masayasu, Tanahashi, Norio, Momomura, Shin-ichi, Uchiyama, Shinichiro, Goto, Shinya, Izumi, Tohru, Koretsune, Yukihiro, Kajikawa, Mariko, Kato, Masaharu, Ueda, Hitoshi, Iwamoto, Kazuya, Tajiri, Masahiro, on behalf of the J-ROCKET AF study investigators·2012·Circulation Journal

Abstract

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 15 mg 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.

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Crossref · 10.1253/circj.cj-12-0454

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Metadata

Authors
Hori, M., Matsumoto, M., Tanahashi, N., Momomura, S.-I., Uchiyama, S., Goto, S., Izumi, T., Koretsune, Y., Kajikawa, M., Kato, M., Ueda, H., Iwamoto, K., Tajiri, M., & on behalf of the J-ROCKET AF study investigators
Venue
Circulation Journal
Published
2012
Volume
76
Issue
9
Pages
2104-2111
ISSN
  • 1346-9843 (ISSN-L)
  • 1347-4820
OpenAlex
W2320128544
Cited by
641
References
13
FWCI
32.42
Type
journal article
Language
en
Open access
bronze

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CoChat. (2026). Citation check: Rivaroxaban vs. Warfarin in Japanese Patients With Atrial Fibrillation: – The J-ROCKET AF Study –. https://app.cochat.ai/papers/10.1253/circj.cj-12-0454
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Hori, M., Matsumoto, M., Tanahashi, N., Momomura, S.-I., Uchiyama, S., Goto, S., Izumi, T., Koretsune, Y., Kajikawa, M., Kato, M., Ueda, H., Iwamoto, K., Tajiri, M., & on behalf of the J-ROCKET AF study investigators. (2012). Rivaroxaban vs. Warfarin in Japanese Patients With Atrial Fibrillation: – The J-ROCKET AF Study –. Circulation Journal. https://doi.org/10.1253/circj.cj-12-0454

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

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