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Circ J. 2012;76(9):2104-11. Epub 2012 Jun 5.

Rivaroxaban vs. warfarin in Japanese patients with atrial fibrillation – the J-ROCKET AF study –.

Collaborators (1177)

Hori M, Matsumoto M, Tanahashi N, Momomura S, Uchiyama S, Goto S, Izumi T, Koretsune Y, Kobayashi S, Ogawa S, Origasa H, Hayashi N, Kihara H, Ishizaki E, Nishimura M, Urabe K, Kudo Y, Nozawa A, Goto M, Aoyama S, Haruhara N, Maeda I, Kawamoto T, Oiwa H, Kato N, Ishii K, Matsumoto T, Yoshida D, Okada H, Nambu T, Shogase T, Chiba S, Oimatsu H, Fukuma T, Kita H, Genda S, Kudo T, Yamamoto T, Kushibiki M, Utsugisawa K, Nagane Y, Suzuki M, Tsurutani H, Shimizu T, Saito H, Matsunaga M, Kayaba M, Shinozaki T, Ikeda S, Tamaru T, Ishizuka T, Tomioka T, Shimizu T, Onoue N, Tanikawa T, Baba S, Tanaka M, Suzuki Y, Narikawa K, Sato T, Suzuki S, Fukuchi M, Fukuchi M, Taguchi S, Niibori K, Kokubo H, Ikeda S, Yamada R, Tabata F, Nakayama K, Yomo T, Ishiyama M, Nakayama A, Abe D, Akiyama D, Takeyasu N, Suzuki S, Morimoto T, Kuroki K, Hatori M, Misaki M, Ogata T, Uno K, Nishi I, Uno K, Ogata T, Misaki M, Oki J, Nishi I, Tabata H, Nagasaki H, Watanabe H, Nakagawa K, Makiyama Y, Onouchi K, Noguchi E, Saito A, Tamura Y, Akanuma J, Inoue Y, Taneichi Y, Atobe T, Masuyama K, Majima A, Tange S, Ono Y, Ui G, Niwamae N, Nishimura S, Oshida Y, Suzuki M, Naito K, Ozoe A, Hosaka H, Manabe T, Moriya M, Sasaoka T, Osaka T, Watanabe I, Yamaguchi T, Kuboi K, Hoda S, Miyamoto N, Seki K, Sakurada M, Tsukagoshi M, Yoneyama S, Katayama N, Miyake T, Kanda J, Miyaji K, Matsunaga T, Kushida S, Sato K, Kodera S, Saito T, Ikeya Y, Uehara T, Oya T, Ito K, Endo M, Nagashima H, Kaneda H, Kitamura S, Shigyo K, Watanabe Y, Yamazaki M, Endo M, Kammatsuse K, Kakizawa Y, Yamada A, Hirata F, Kakihara H, Kubo T, Hayashi Y, Momose Y, Hattori I, Kimura T, Sugawara M, Morimoto M, Kumamoto S, Shoji H, Yoshida H, Nemoto A, Hoshino T, Fukui K, Fukushima Y, Tanaka Y, Izawa T, Goshima K, Ozaki H, Kato S, Nakatogawa T, Nakagawa T, Okusu Y, Hosoda J, Okabe M, Sato M, Takahashi M, Kitazawa H, Ikebe Y, Fujita S, Saito A, Fuse K, Shimomura T, Oshima T, Inoue H, Tanaka K, Takashima S, Taguchi Y, Toyoda S, Dogu N, Fujiki A, Mizumaki K, Hirai T, Nozawa T, Sakai R, Ogiwara T, Kamijo Y, Takizawa T, Hattori T, Shimojima Y, Shimojima Y, Chino C, Takemura T, Sakaguchi M, Watanabe H, Tamura Y, Oowa M, Ito K, Hikita H, Kuroyanagi T, Tokushige K, Tsuyuzaki J, Kai R, Ito K, Tsuboi H, Sasaki H, Yamamoto T, Sone T, Mukawa H, Morishima I, Uesugi M, Takagi K, Morikawa S, Izumi Y, Niwa T, Wakahara N, Watanabe T, Kawaguchi Y, Kitagawa M, Kumazawa A, Nakano T, Yoshihara S, Suzuki A, Uesugi K, Kanno D, Watanabe T, Sakamoto A, Yamada A, Aoyama T, Kondo M, Tanio H, Araki M, Kubota T, Matsuoka R, Kanamori N, Kawahito M, Nagura H, Kondo Y, Tsuboi N, Kato H, Mitsui T, Fujishiro K, Suzuki K, Nakanishi H, Murakami H, Riku S, Kada K, Ando K, Sato B, Okumura S, Ono M, Riku Y, Niimi Y, Miura M, Nagahiro T, Wakayama T, Nakamura R, Sakurai H, Kataoka Y, Kito T, Kamiya H, Makino M, Shibata Y, Mano K, Kato T, Goto Y, Sobue T, Hayashida R, Sano H, Kato R, Awaji Y, Ishihara D, Noda H, Okumura T, Okumura N, Shimizu S, Noda T, Hanada M, Fujita S, Hirata K, Takeda I, Sakagami S, Ikeda K, Omi W, Kojima H, Yamamoto K, Yaegashi T, Nakamura Y, Saeki T, Okura S, Hanaoka R, Mori K, Nagata M, Oe K, Ueda Y, Onaka H, Okamoto F, Otsuka K, Kimata A, Fujii K, Takagi T, Morisawa D, Omiya S, Kimura R, Suenaga H, Kubota A, Ito H, Iwakura K, Okamura A, Kurotobi T, Koyama Y, Date M, Higuchi Y, Inoue K, Nagai H, Imai M, Toyoshima Y, Arita Y, Ozawa M, Ito N, Okazaki Y, Shibuya M, Tsushima N, Ryomoto T, Kijima Y, Kume K, Hata T, Nakagawa Y, Nishibe A, Matsuo A, Kunishige M, Oku K, Kanehara N, Higasa S, Hamaguchi H, Torii H, Otani N, Sasaki T, Irino H, Hashimoto K, Yasuoka Y, Abe H, Yoshida Y, Tomino Y, Fukumori T, Yoshida Y, Matsumoto S, Masuda A, Tominaga S, Sugii M, Mori T, Kawanaka M, Hayakawa Y, Kishi K, Kataoka Y, Ko M, Sawasaki M, Nakamura K, Morimoto S, Matsubara N, Yamauchi T, Kuroda Y, Igarashi N, Itatani M, Taniguchi Y, Murata T, Matsumoto D, Takamine S, Ujihira T, Sarashina T, Sunami H, Sato T, Saito H, Ikeda T, Yoshioka R, Kobata R, Fujiwara Y, Kaneto T, Kitae S, Shimoda K, Inoue K, Doi M, Okada H, Goto A, Tamura K, Hashimoto S, Yoshikawa H, Takamori N, Yamaguchi H, Hirono A, Choraku M, Nishiuchi T, Akaike M, Ueda Y, Ise T, Hayashi I, Kimura T, Yagi S, Suzuki M, Kazatani Y, Mineoi K, Yamada T, Seike F, Miyoshi A, Shimizu H, Fujita S, Sato S, Takagi Y, Kawada Y, Nishiyama A, Izumi N, Sasaki Y, Suzuki M, Nakamura Y, Matsunaka T, Kakishita M, Habara H, Funada J, Morioka N, Hashida H, Fujii A, Takaoka Y, Murakami S, Fujita T, Murakami M, Nishino K, Sato T, Fujita H, Harada H, Uesugi T, Sakane K, Doi M, Matsushita J, Uesugi T, Sakane K, Kaji Y, Mima T, Ida J, Takeda S, Nishizaki O, Kawai T, Takagaki K, Mohri M, Hayashidani S, Noma M, Yamamoto H, Origuchi H, Miyata K, Yamamoto U, Sakamoto I, Hisadome T, Toyama N, Toyama N, Hokao K, Hisadome T, Sasaki Y, Masuda T, Yoshikai S, Hijikawa Y, Sagara M, Teshima S, Noguchi H, Ikeda N, Saito N, Ishibashi F, Fujioka S, Saito T, Higa T, Fujino Y, Tsugawa J, Fukuhara K, Nakamura K, Saku K, Yasuda T, Ogawa M, Fujimi K, Morito N, Kubota K, Hida S, Kumagai K, Matsunaga A, Noda K, Shirai K, Miura S, Nishikawa H, Matsumoto M, Kawamura A, Sakoh H, Iwata A, Urata H, Kubota K, Fukuda Y, Matsumoto K, Tojo H, Furuyama S, Maruyama S, Miyoshi K, Ando C, Kodama S, Okamura K, Kudo K, Sumi S, Niimura H, Yamanouchi Y, Tsuchiya Y, Mihara H, Go Y, Tanaka H, Shiraishi T, Serikawa T, Goto Y, Orita Y, Ikeda S, Shintani Y, Kawasaki T, Otsubo Y, Tanaka H, Tomita H, Kusaba H, Akashi T, Tomita H, Yano H, Matsumura J, Suzuki S, Honda Y, Nakashima H, Ishizaki M, Fujimoto K, Koga H, Kanazawa H, Fukushima R, Nakata M, Suzuki S, Miyao Y, Murakami K, Tanaka T, Hashino T, Nakagawara J, Yamazaki T, Takada H, Hara K, Fumoto K, Kataoka T, Watanabe T, Oikawa M, Noro S, Oie T, Hashiguchi R, Taniguchi Y, Kira T, Arikawa M, Maeda T, Ichikawa S, Nozue M, Terada Y, Sekii H, Hayama Y, Yamamoto E, Ueda O, Fukino K, Sugawara S, Saeki K, Oshima S, Yokota M, Saito S, Suenaga H, Izumikawa T, Hone J, Takeshita S, Kawada J, Shishido K, Okamura N, Miyashita Y, Shiono T, Takahashi S, Kaneda H, Taketani Y, Matsumoto N, Matsumi J, Domae H, Minami Y, Sugitatsu K, Tanaka S, Mizuno S, Kamei T, Iino M, Kawase Y, Aizawa N, Yamanoue H, Kadena M, Takashima Y, Nakatsuka S, Fukushima T, Asakura T, Fukushima T, Nakatsuka S, Asakura T, Kageyama S, Mitsui H, Kametani R, Kimura T, Sueyoshi A, Okamoto M, Masuda K, Tanaka T, Hamaguchi K, Amano T, Matsuoka S, Takahashi A, Hirai H, Fujibayashi T, Anayama R, Kitano T, Nishiyama A, Miyamoto M, Ito K, Yamasaki K, Tsuruta Y, Sumitsuji S, Tanaka K, Okutsu M, Okamoto M, Higashiue S, Izuta M, Tanaka K, Komooka M, Sekii H, Tonda H, Nota H, Azuma S, Hiramatsu N, Shimomura H, Kudo T, Hanaoka Y, Chazono N, Yamada Y, Yamashita T, Oba K, Nako H, Ogura Y, Koyama H, Chitose T, Yamaguchi M, Nagata T, Nakamura Y, Iha K, Minami D, Oshiro H, Sasaki A, Ishitobi S, Tokeshi Y, Fukuhara N, Minei S, Higa N, Miyagi K, Shingaki T, Ikemura R, Kkuninaga N, Yoshii H, Arai A, Shintomi Y, Kubo S, Sadamoto Y, Yano K, Nomoto T, Morishima A, Enomoto D, Sano M, Ishida M, Misumi K, Kuramochi T, Iizuka D, Kubo T, Itakura Y, Yoshiwara H, Tone K, Hirose M, Shimizu S, Kadota K, Yamamoto M, Ouchi K, Araki Y, Seki M, Kuwashima K, Shiga K, Matsuo T, Shinoda Y, Haruna T, Nagai K, Haruna T, Nohara R, Inoko M, Hosokawa R, Miyamoto S, Nakane E, Uehara K, Ueyama K, Matsumoto S, Hayashi Y, Kasamatsu K, Hayashi Y, Sakai Y, Kuki S, Kitamura M, Sakatani T, Tsubakimoto Y, Shimoda Y, Yamamoto Y, Ohara T, Tateishi K, Makita N, Fujita H, Tanaka T, Inoue K, Matsuo A, Nishibori Y, Yamaguchi S, Shiono Y, Nakanishi N, Matsuo K, Yamada T, Yasui T, Tanaka K, Masuda M, Iwasaki Y, Sanada S, Fukunami M, Morita T, Okuyama Y, Furukawa Y, Tsukamoto Y, Yonemasu Y, Takahashi A, Saito M, Yonemasu Y, Sakai J, Harada K, Asonuma H, Watanabe A, Sakakibara T, Harada K, Shimono T, Kato B, Kato M, Amano T, Marui N, Uetani T, Kumagai S, Ando H, Yokoi K, Yoshida T, Yokoi T, Kamijo M, Umemura T, Kitaguchi S, Tada E, Higuchi T, Ueda Y, Kodama M, Haruna Y, Ishii K, Ozaki M, Yamauchi R, Takenaka H, Takenaka K, Fujiwara H, Shimomura T, Watanabe C, Fujimoto T, Koretsune Y, Yasumura Y, Komukai K, Yanagi I, Yamamoto E, Cho T, Kaji Y, Takeda F, Chiba K, Kanwo K, Kawahara T, Hitomi H, Fujii S, Shimatani Y, Shimoyama Y, Yagi M, Fujimori K, Kobayashi H, Suzuki F, Kasai Y, Kitamura K, Mita S, Suzuki A, Fujita T, Higuchi H, Eki Y, Watanabe Y, Yukawa A, Yamauchi R, Seino Y, Hayashi M, Aoki S, Sato W, Yodogawa K, Ono N, Ibuki C, Sugi K, Hara H, Sakata T, Kujime S, Noro M, Tezuka N, Numata A, Moriyama A, Satake K, Mizuguchi T, Kobayashi Y, Shirasaki H, Geshi T, Miura T, Kinomoto K, Hirasawa S, Fukaya H, Ishii S, Imaki R, Kiryu M, Kishihara J, Harano K, Ishigami M, Kodaira M, Nishizaki M, Yamawake N, Ashikaga T, Fujii H, Maeda S, Murai N, Ihara K, Niki S, Okayama H, Higaki J, Otsuka T, Ogimoto A, Suzuki J, Onishi T, Kumon Y, Watanabe H, Igase K, Fukumoto S, Nomoto M, Nagai M, Moritoyo T, Takagi Y, Mizukawa M, Mori Y, Maeda T, Yoshida M, Awai K, Arakawa Y, Yachida T, Yamana Y, Tanimoto N, Matsumoto I, Hosokawa H, Honda K, Oryu M, Inoue A, Hatashita S, Minami Y, Sugitatsu K, Tanaka S, Mizuno S, Yamasaki H, Kusunoki K, Kanehisa Y, Tanaka K, Miki O, Watanabe K, Saeki H, Saikawa T, Wakisaka O, Hara M, Takahashi N, Yufu K, Shinohara T, Okada N, Inoue T, Konno S, Ishikawa H, Kaga S, Kawamitsu K, Kowatari T, Akasaki M, Kadekaru T, Shimoji M, Uezu T, Hattori M, Taira T, Yamakawa K, Higa S, Furui K, Hayakata Y, Kubo T, Tomizawa M, Tokunaga T, Ando S, Yoshida M, Nishi J, Narita S, Matsumoto M, Momii H, Kadokami T, Kawamura N, Funakoshi H, Takeshita A, Nagao T, Nirei T, Hiyoshi Y, Yamada T, Goto K, Yokochi M, Okamura M, Kobayashi M, Yoshimura N, Takubo H, Wada A, Omura Y, Matsumoto T, Yamamoto T, Onishi M, Sasaki T, Baba M, Kakinoki S, Takagi C, Nagai K, Adachi S, Takamura C, Hagimoto N, Gotoh R, Tsuchiyama T, Fukunaga R, Ito T, Takahashi T, Shimizu Y, Sugiura S, Toratani N, Sawada M, Takano Y, Tsuchida A, Hasegawa T, Namba M, Endo T, Sakamoto J, Sakurai S, Mawatari E, Suzuki C, Aso S, Hisamatsu Y, Ryoke T, Sada K, Hisamatsu Y, Tokuhisa T, Shigematsu S, Mitsuo K, Tanaka K, Ichinose M, Maeda T, Akutagawa N, Narumiya K, Tsunoda S, Sawada M, katahira Y, Sugawara S, Yamanaka T, Nakano T, Yamaguchi T, Yanbe M, Tabuchi H, Ogawa H, Wakeyama T, Iwami T, Kimura M, Hadano Y, Mochizuki M, Taniguchi H, Masubuchi T, Deguchi J, Ogawa D, Hamada E, Manno T, Miyamoto N, Kaneko M, Tatsukawa Y, Nagase K, Sato T, Ishikawa T, Inobe Y, Ishimatsu T, Okishige K, Kurabayashi M, Shimura T, Azegami K, Aoyagi H, Maeda M, Sugiyama K, Hiroe M, Iwashima Y, Tanaka Y, Soejima Y, Tamori Y, Kamimura M, Okazaki O, Ogasawara Y, Muto M, Takanaka C, Takanaka C, Oya M, Sugiyama T, Muto M, Kobayashi M, Sawazaki K, Ota T, Takayama Y, Otomo T, Kondo M, Yoshida S, Yamamoto K, Seto S, Iwasa A, Fujiwara K, Kusaba T, Inage T, Ikefuji H, Todoroki T, Hamazaki F, Mizuo K, Miyamoto M, Watanabe K, Matsuura Y, Saeki H, Ueki A, Kusano K, Taniyama M, Hata Y, Morita H, Nakamura K, Nagase S, Nnishii N, Tani Y, Fuke S, Murakami M, Tada T, Hiramatsu S, Takahashi J, Nakamura K, Okude J, Wakamatsu Y, Kanno M, Kanaoka T, Osaka T, Yokoyama E, Matsumoto N, Watanabe Y, Osada N, Kishi R, Osada K, Akashi Y, Ryu S, Hirayama A, Hiro T, Watanabe I, Hone J, Kasamaki Y, Takayama T, Kunimoto S, Nakai T, Yoda S, Chiku M, Yajima Y, Saruya T, Kofune T, Okubo K, Kawase Y, Wakida Y, Fujita H, Mizuno R, Masago M, Fukuda M, Hasegawa R, Nakagawa J, Kato I, Wakida Y, Kaneko Y, Saito A, Irie T, Kurabayashi M, Nakajima T, Hata T, Hata Y, Yanaga T, Imamura K, Kobayashi Y, Mabuchi N, Kobayashi Y, Yamazaki J, Takamura K, Kobayashi K, Nakano H, Namiki A, Nanjo S, Inoue A, Okano Y, Fujimoto S, Takamura K, Tejima T, Sakurada H, Yuba T, Tejima T, Fukamizu S, Tanabe Y, Mizusawa Y, Tatsumoto A, Komiyama K, Keida T, Ohira H, Himeno H, Fukuoka T, Yotsukura H, Kanna M, Yano H, Arakawa K, Takamizawa T, Akiyama E, Yasaka M, Mori M, Ogata T, Wakugawa Y, Miyazaki Y, Makihara N, Nakamura A, Shimada J, Takahashi K, Kanazawa Y, Yokoyama T, Takano S, Okada Y, Yamazaki S, Aoki K, Takeuchi T, Hachinohe D, Tani T, Hashidomi H, Asanome A, Shintani S, Miki K, Numazawa Y, Hino T, Ishihara S, Hori T, Kanno M, Ishikawa K, Harada H, Fukuda K, Uryu K, Sakota S, Yoshimaru K, Matsumoto A.

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.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00494871.

PMID:
22664783
[Indexed for MEDLINE]
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