Clinical trial NCT00494871: Efficacy and Safety of Rivaroxaban for the Prevention of Stroke in Subjects With Non-Valvular Atrial Fibrillation
Official title: Evaluation of the Efficacy and Safety of Rivaroxaban (BAY59-7939) for the Prevention of Stroke and Non-central Nervous System Systemic Embolism in Subjects With Non-valvular Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atrial Fibrillation
Keywords: BAY59-7939
Rivaroxaban
Non-Valvular Atrial Fibrillation
Japanese Patients
Phase III
12620
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Janssen R&D, L.L.C.
First posted: 2007-07-02
Enrollment: 1280
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a clinical study evaluating the efficacy and safety of rivaroxaban for stroke prevention in patients with atrial fibrillation (originally described in Japanese).

Detailed description: Within the US 'Johnson \& Johnson Pharmaceutical Research \& Development, L.L.C.' is sponsor.

Eligibility criteria: Inclusion Criteria:

* 20 years or older
* Japanese male or female
* Non- valvular atrial fibrillation documented by ECG
* Patients with a risk of stroke and non-CNS systemic embolism

Exclusion Criteria:

* Significant mitral stenosis
* Patients in whom anticoagulants are contraindicated

Primary outcomes:
measure: Event Rate of the Composite Endpoint of Adjudicated Major Bleeding or Adjudicated Non-major Clinically Relevant Bleeding
timeFrame: Up to 2 days after the last dose
Secondary outcomes:
measure: Event Rate of the Composite Endpoint of Adjudicated Stroke and Non-central Nervous System (CNS) Systemic Embolism
timeFrame: Up to 2 days after the last dose
measure: Event Rate of the Composite Endpoint of Adjudicated Stroke, Non-CNS Systemic Embolism, and Vascular Death
timeFrame: Up to 2 days after the last dose
measure: Event Rate of the Composite Endpoint of Adjudicated Stroke, Non-CNS Systemic Embolism, Myocardial Infarction, and Vascular Death
timeFrame: Up to 2 days after the last dose
measure: Event Rate of Stroke
timeFrame: Up to 2 days after the last dose
measure: Event Rate of Non-CNS Systemic Embolism
timeFrame: Up to 2 days after the last dose
measure: Event Rate of Myocardial Infarction
timeFrame: Up to 2 days after the last dose
measure: Event Rate of Vascular Death
timeFrame: Up to 2 days after the last dose
measure: Event Rate of Stroke With Serious Residual Disability
timeFrame: Up to 2 days after the last dose
measure: Event Rate of All-cause Death
timeFrame: Up to 2 days after the last dose
measure: Event Rate of Adjudicated Major Bleeding
timeFrame: Up to 2 days after the last dose
measure: Event Rate Adjudicated Non-major Clinically Relevant Bleeding
timeFrame: Up to 2 days after the last dose
Other outcomes:
Locations:
city: Kasugai
country: Japan
state: Aichi
city: Nagoya
country: Japan
state: Aichi
city: Nagoya
country: Japan
state: Aichi
city: Nagoya
country: Japan
state: Aichi
city: Nagoya
country: Japan
state: Aichi
city: Nagoya
country: Japan
state: Aichi
city: Okazaki
country: Japan
state: Aichi
city: Goshogawara
country: Japan
state: Aomori
city: Hirosaki
country: Japan
state: Aomori
city: Hirosaki
country: Japan
state: Aomori
city: Asahi
country: Japan
state: Chiba
city: Funabashi
country: Japan
state: Chiba
city: Imba
country: Japan
state: Chiba
city: Matsudo
country: Japan
state: Chiba
city: Matsudo
country: Japan
state: Chiba
city: Yotsukaido
country: Japan
state: Chiba
city: Imabari
country: Japan
state: Ehime
city: Matsuyama
country: Japan
state: Ehime
city: Matsuyama
country: Japan
state: Ehime
city: Matsuyama
country: Japan
state: Ehime
city: Niihama
country: Japan
state: Ehime
city: Saijo
country: Japan
state: Ehime
city: Toon
country: Japan
state: Ehime
city: Chikushi-gun
country: Japan
state: Fukuoka
city: Chikushino
country: Japan
state: Fukuoka
city: Chikushino
country: Japan
state: Fukuoka
city: Kasuga
country: Japan
state: Fukuoka
city: Kasuga
country: Japan
state: Fukuoka
city: Kitakyushu
country: Japan
state: Fukuoka
city: Kitakyushu
country: Japan
state: Fukuoka
city: Kurume
country: Japan
state: Fukuoka
city: Ogori
country: Japan
state: Fukuoka
city: Yame
country: Japan
state: Fukuoka
city: Yame
country: Japan
state: Fukuoka
city: Koriyama
country: Japan
state: Fukushima
city: Ogaki
country: Japan
state: Gifu
city: Maebashi
country: Japan
state: Gunma
city: Mebashi
country: Japan
state: Gunma
city: Otake
country: Japan
state: Hiroshima
city: Asahikawa
country: Japan
state: Hokkaido
city: Chitose
country: Japan
state: Hokkaido
city: Hakodate
country: Japan
state: Hokkaido
city: Muroran
country: Japan
state: Hokkaido
city: Otaru
country: Japan
state: Hokkaido
city: Sapporo
country: Japan
state: Hokkaido
city: Sapporo
country: Japan
state: Hokkaido
city: Sapporo
country: Japan
state: Hokkaido
city: Sapporo
country: Japan
state: Hokkaido
city: Sapporo
country: Japan
state: Hokkaido
city: Sapporo
country: Japan
state: Hokkaido
city: Sapporo
country: Japan
state: Hokkaido
city: Sapporo
country: Japan
state: Hokkaido
city: Sapporo
country: Japan
state: Hokkaido
city: Sunagawa
country: Japan
state: Hokkaido
city: Tomakomai
country: Japan
state: Hokkaido
city: Kobe
country: Japan
state: Hyogo
city: Kobe
country: Japan
state: Hyogo
city: Kobe
country: Japan
state: Hyogo
city: Higashiibaraki
country: Japan
state: Ibaraki
city: Hitachi
country: Japan
state: Ibaraki
city: Joso
country: Japan
state: Ibaraki
city: Kasama
country: Japan
state: Ibaraki
city: Moriya
country: Japan
state: Ibaraki
city: Namegata
country: Japan
state: Ibaraki
city: Toride
country: Japan
state: Ibaraki
city: Kanazawa
country: Japan
state: Ishikawa
city: Nomi
country: Japan
state: Ishikawa
city: Hanamaki
country: Japan
state: Iwate
city: Morioka
country: Japan
state: Iwate
city: Marugame
country: Japan
state: Kagawa
city: Takamatsu
country: Japan
state: Kagawa
city: Izumi
country: Japan
state: Kagoshima
city: Atsugi
country: Japan
state: Kanagawa
city: Fujisawa
country: Japan
state: Kanagawa
city: Fujisawa
country: Japan
state: Kanagawa
city: Kamakura
country: Japan
state: Kanagawa
city: Kawasaki
country: Japan
state: Kanagawa
city: Yokohama
country: Japan
state: Kanagawa
city: Yokohama
country: Japan
state: Kanagawa
city: Yokohama
country: Japan
state: Kanagawa
city: Yokohama
country: Japan
state: Kanagawa
city: Nangoku
country: Japan
state: Kochi
city: Uji
country: Japan
state: Kyoto
city: Kuwana
country: Japan
state: Mie
city: Sendai
country: Japan
state: Miyagi
city: Sendai
country: Japan
state: Miyagi
city: Sendai
country: Japan
state: Miyagi
city: Sendai
country: Japan
state: Miyagi
city: Sendai
country: Japan
state: Miyagi
city: Komoro
country: Japan
state: Nagano
city: Matsumoto
country: Japan
state: Nagano
city: Suwa
country: Japan
state: Nagano
city: Joetsu
country: Japan
state: Niigata
city: Nagaoka
country: Japan
state: Niigata
city: Beppu
country: Japan
state: Oita
city: Beppu
country: Japan
state: Oita
city: Yufu
country: Japan
state: Oita
city: Kasaoka
country: Japan
state: Okayama
city: Shimajiri
country: Japan
state: Okinawa
city: Daito
country: Japan
state: Osaka
city: Higashiosaka
country: Japan
state: Osaka
city: Hirakata
country: Japan
state: Osaka
city: Hirakata
country: Japan
state: Osaka
city: Kawachinagano
country: Japan
state: Osaka
city: Kishiwada
country: Japan
state: Osaka
city: Takatsuki
country: Japan
state: Osaka
city: Toyonaka
country: Japan
state: Osaka
city: Yao
country: Japan
state: Osaka
city: Hanyu
country: Japan
state: Saitama
city: Kasukage
country: Japan
state: Saitama
city: Kitamoto
country: Japan
state: Saitama
city: Tokorozawa
country: Japan
state: Saitama
city: Tokorozawa
country: Japan
state: Saitama
city: Wako
country: Japan
state: Saitama
city: Kusatsu
country: Japan
state: Shiga
city: Fujinomiya
country: Japan
state: Shizuoka
city: Fukuroi
country: Japan
state: Shizuoka
city: Hamamatsu
country: Japan
state: Shizuoka
city: Hamamatsu
country: Japan
state: Shizuoka
city: Iwata
country: Japan
state: Shizuoka
city: Shimada
country: Japan
state: Shizuoka
city: Naruto
country: Japan
state: Tokushima
city: Edogawa-ku
country: Japan
state: Tokyo
city: Hachioji
country: Japan
state: Tokyo
city: Higashikurume
country: Japan
state: Tokyo
city: Itabashi-ku
country: Japan
state: Tokyo
city: Itabashi-ku
country: Japan
state: Tokyo
city: Meguro-ku
country: Japan
state: Tokyo
city: Ota-ku
country: Japan
state: Tokyo
city: Shibuya-ku
country: Japan
state: Tokyo
city: Shinagawa-ku
country: Japan
state: Tokyo
city: Shinjuku-ku
country: Japan
state: Tokyo
city: Higashikawada
country: Japan
state: Yamagata
city: Shimonoseki
country: Japan
state: Yamaguchi
city: Shunan
country: Japan
state: Yamaguchi
city: Fukui
country: Japan
city: Fukuoka
country: Japan
city: Fukuoka
country: Japan
city: Fukuoka
country: Japan
city: Fukuoka
country: Japan
city: Gifu
country: Japan
city: Kagoshima
country: Japan
city: Kumamoto
country: Japan
city: Kyoto
country: Japan
city: Nagasaki
country: Japan
city: Oita
country: Japan
city: Oita
country: Japan
city: Oita
country: Japan
city: Oita
country: Japan
city: Okayama
country: Japan
city: Okayama
country: Japan
city: Okinawa
country: Japan
city: Osaka
country: Japan
city: Osaka
country: Japan
city: Osaka
country: Japan
city: Osaka
country: Japan
city: Osaka
country: Japan
city: Osaka
country: Japan
city: Shizuoka
country: Japan
city: Shizuoka
country: Japan
city: Shizuoka
country: Japan
city: Tokushima
country: Japan
city: Tottori
country: Japan
city: Toyama
country: Japan
city: Wakayama
country: Japan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Hori M, Matsumoto M, Tanahashi N, Momomura S, Uchiyama S, Goto S, Izumi T, Koretsune Y, Kajikawa M, Kato M, Ueda H, Iwamoto K, Tajiri M; J-ROCKET AF study investigators. Rivaroxaban vs. warfarin in Japanese patients with atrial fibrillation - the J-ROCKET AF study -. Circ J. 2012;76(9):2104-11. doi: 10.1253/circj.cj-12-0454. Epub 2012 Jun 5.
citation: Chan MY, Lin M, Lucas J, Moseley A, Thompson JW, Cyr D, Ueda H, Kajikawa M, Ortel TL, Becker RC. Plasma proteomics of patients with non-valvular atrial fibrillation on chronic anti-coagulation with warfarin or a direct factor Xa inhibitor. Thromb Haemost. 2012 Dec;108(6):1180-91. doi: 10.1160/TH12-05-0310. Epub 2012 Oct 10.
citation: Tanahashi N, Hori M, Matsumoto M, Momomura S, Uchiyama S, Goto S, Izumi T, Koretsune Y, Kajikawa M, Kato M, Ueda H, Iwamoto K, Tajiri M; J-ROCKET AF Study Investigators. Rivaroxaban versus warfarin in Japanese patients with nonvalvular atrial fibrillation for the secondary prevention of stroke: a subgroup analysis of J-ROCKET AF. J Stroke Cerebrovasc Dis. 2013 Nov;22(8):1317-25. doi: 10.1016/j.jstrokecerebrovasdis.2012.12.010. Epub 2013 Jan 22.
citation: Hori M, Matsumoto M, Tanahashi N, Momomura S, Uchiyama S, Goto S, Izumi T, Koretsune Y, Kajikawa M, Kato M, Ueda H, Iwamoto K, Tajiri M; J-ROCKET AF study investigators. Safety and efficacy of adjusted dose of rivaroxaban in Japanese patients with non-valvular atrial fibrillation: subanalysis of J-ROCKET AF for patients with moderate renal impairment. Circ J. 2013;77(3):632-8. doi: 10.1253/circj.cj-12-0899. Epub 2012 Dec 8.
citation: Tanigawa T, Kaneko M, Hashizume K, Kajikawa M, Ueda H, Tajiri M, Paolini JF, Mueck W. Model-based dose selection for phase III rivaroxaban study in Japanese patients with non-valvular atrial fibrillation. Drug Metab Pharmacokinet. 2013;28(1):59-70. doi: 10.2133/dmpk.dmpk-12-rg-034. Epub 2012 Jul 17.
citation: Kaneko M, Tanigawa T, Hashizume K, Kajikawa M, Tajiri M, Mueck W. Confirmation of model-based dose selection for a Japanese phase III study of rivaroxaban in non-valvular atrial fibrillation patients. Drug Metab Pharmacokinet. 2013;28(4):321-31. doi: 10.2133/dmpk.dmpk-12-rg-109. Epub 2013 Jan 22.
citation: Matsumoto M, Hori M, Tanahashi N, Momomura S, Uchiyama S, Goto S, Izumi T, Koretsune Y, Kajikawa M, Kato M, Ueda H, Iekushi K, Yamanaka S, Tajiri M; J-ROCKET AF Study Investigators. Rivaroxaban versus warfarin in Japanese patients with non-valvular atrial fibrillation in relation to hypertension: a subgroup analysis of the J-ROCKET AF trial. Hypertens Res. 2014 May;37(5):457-62. doi: 10.1038/hr.2014.1. Epub 2014 Jan 30.
citation: Uchiyama S, Hori M, Matsumoto M, Tanahashi N, Momomura S, Goto S, Izumi T, Koretsune Y, Kajikawa M, Kato M, Ueda H, Iekushi K, Yamanaka S, Tajiri M; J-ROCKET AF Study Investigators. Net clinical benefit of rivaroxaban versus warfarin in Japanese patients with nonvalvular atrial fibrillation: a subgroup analysis of J-ROCKET AF. J Stroke Cerebrovasc Dis. 2014 May-Jun;23(5):1142-7. doi: 10.1016/j.jstrokecerebrovasdis.2013.10.001. Epub 2013 Nov 1.
citation: Hori M, Matsumoto M, Tanahashi N, Momomura S, Uchiyama S, Goto S, Izumi T, Koretsune Y, Kajikawa M, Kato M, Ueda H, Iekushi K, Yamanaka S, Tajiri M; J-ROCKET AF Study Investigators. Rivaroxaban versus warfarin in Japanese patients with nonvalvular atrial fibrillation in relation to the CHADS2 score: a subgroup analysis of the J-ROCKET AF trial. J Stroke Cerebrovasc Dis. 2014 Feb;23(2):379-83. doi: 10.1016/j.jstrokecerebrovasdis.2013.07.021. Epub 2013 Aug 15.
citation: Hori M, Kajikawa M. The J-ROCKET AF Study: a matter of ethnicity or a matter of weight? Reply. Circ J. 2013;77(10):2637. doi: 10.1253/circj.cj-13-0879. Epub 2013 Aug 1. No abstract available.
citation: Hori M, Matsumoto M, Tanahashi N, Momomura S, Uchiyama S, Goto S, Izumi T, Koretsune Y, Kajikawa M, Kato M, Ueda H, Iekushi K, Yamanaka S, Tajiri M; J-ROCKET AF Study Investigators. Rivaroxaban vs. warfarin in Japanese patients with non-valvular atrial fibrillation in relation to age. Circ J. 2014;78(6):1349-56. doi: 10.1253/circj.cj-13-1324. Epub 2014 Apr 7.