Efficacy and Safety of Rivaroxaban for the Prevention of Stroke in Subjects With Non-Valvular Atrial Fibrillation
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
1 other identifier
interventional
1,280
1 country
165
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 atrial-fibrillation
Started Jun 2007
165 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 29, 2007
CompletedFirst Posted
Study publicly available on registry
July 2, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedResults Posted
Study results publicly available
April 19, 2012
CompletedApril 20, 2015
April 1, 2015
2.5 years
June 29, 2007
March 28, 2012
April 1, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Event Rate of the Composite Endpoint of Adjudicated Major Bleeding or Adjudicated Non-major Clinically Relevant Bleeding
Major bleeding: clinically overt bleeding (COB) associated with a fall in hemoglobin ≥2 g/dL, leading to transfusion ≥2 units of packed red blood cells or whole blood, occurring in a critical site or contributing to death. Non-major clinically relevant bleeding: COB that does not meet the definition of major bleeding, but requires medical intervention or unscheduled contact with the physician, (temporary) discontinuation of the study treatment, discomfort to the subject such as pain, or impairment of activities of daily life.
Up to 2 days after the last dose
Secondary Outcomes (11)
Event Rate of the Composite Endpoint of Adjudicated Stroke and Non-central Nervous System (CNS) Systemic Embolism
Up to 2 days after the last dose
Event Rate of the Composite Endpoint of Adjudicated Stroke, Non-CNS Systemic Embolism, and Vascular Death
Up to 2 days after the last dose
Event Rate of the Composite Endpoint of Adjudicated Stroke, Non-CNS Systemic Embolism, Myocardial Infarction, and Vascular Death
Up to 2 days after the last dose
Event Rate of Stroke
Up to 2 days after the last dose
Event Rate of Non-CNS Systemic Embolism
Up to 2 days after the last dose
- +6 more secondary outcomes
Study Arms (2)
Rivaroxaban (Xarelto, BAY59-7939)
EXPERIMENTALParticipants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
Warfarin
ACTIVE COMPARATORParticipants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
Interventions
Participants orally administered rivaroxaban 15 mg OD (CrCL \[creatinine clearance\] \>= 50 mL/min) or 10 mg OD (CrCL 30-49 mL/min)
Participants orally administered a warfarin potassium tablet (INR \[international normalized ratio\] target was 1.6-2.6 for patients \>70 years and 2.0-3.0 for patients \<70 years)
Participants orally administered a warfarin placebo tablet (adjusted based upon sham INR values)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Significant mitral stenosis
- Patients in whom anticoagulants are contraindicated
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
- Janssen R&D, L.L.C.collaborator
Study Sites (165)
Unknown Facility
Kasugai, Aichi-ken, 487-0013, Japan
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Nagoya, Aichi-ken, 453-8511, Japan
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Nagoya, Aichi-ken, 454-8502, Japan
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Nagoya, Aichi-ken, 455-8530, Japan
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Nagoya, Aichi-ken, 457-8510, Japan
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Nagoya, Aichi-ken, 462-0825, Japan
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Okazaki, Aichi-ken, 444-8553, Japan
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Goshogawara, Aomori, 037-0053, Japan
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Hirosaki, Aomori, 036-8082, Japan
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Hirosaki, Aomori, 036-8545, Japan
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Asahi, Chiba, 289-2511, Japan
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Funabashi, Chiba, 274-8503, Japan
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Imba, Chiba, 270-1694, Japan
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Matsudo, Chiba, 270-2251, Japan
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Matsudo, Chiba, 271-0077, Japan
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Yotsukaidō, Chiba, 284-0032, Japan
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Imabari, Ehime, 799-1592, Japan
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Matsuyama, Ehime, 790-0024, Japan
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Matsuyama, Ehime, 790-0925, Japan
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Matsuyama, Ehime, 791-8026, Japan
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Niihama, Ehime, 792-8543, Japan
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Saijō, Ehime, 793-0030, Japan
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Tōon, Ehime, 791-0281, Japan
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Fukui-shi, Fukui, 910-0067, Japan
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Chikushi-gun, Fukuoka, 811-1244, Japan
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Chikushino-shi, Fukuoka, 818-8502, Japan
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Chikushino-shi, Fukuoka, 818-8516, Japan
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Fukuoka, Fukuoka, 810-8563, Japan
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Fukuoka, Fukuoka, 811-0213, Japan
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Fukuoka, Fukuoka, 813-0044, Japan
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Fukuoka, Fukuoka, 814-0180, Japan
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Kasuga, Fukuoka, 816-0833, Japan
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Kasuga, Fukuoka, 816-0864, Japan
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Kitakyushu, Fukuoka, 800-0057, Japan
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Kitakyushu, Fukuoka, 806-8501, Japan
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Kurume, Fukuoka, 830-8577, Japan
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Ogōri, Fukuoka, 838-0141, Japan
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Yame, Fukuoka, 834-0004, Japan
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Yame, Fukuoka, 834-0006, Japan
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Kōriyama, Fukushima, 963-8052, Japan
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Gifu, Gifu, 500-8225, Japan
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Ōgaki, Gifu, 503-8502, Japan
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Maebashi, Gunma, 371-8511, Japan
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Mebashi, Gunma, 371-0014, Japan
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Ōtake, Hiroshima, 739-0696, Japan
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Asahikawa, Hokkaido, 078-8214, Japan
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Chitose, Hokkaido, 066-0034, Japan
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Hakodate, Hokkaido, 040-8611, Japan
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Muroran, Hokkaido, 051-8501, Japan
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Otaru, Hokkaido, 047-8510, Japan
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Sapporo, Hokkaido, 004-0052, Japan
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Sapporo, Hokkaido, 060-0033, Japan
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Sapporo, Hokkaido, 060-0061, Japan
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Sapporo, Hokkaido, 060-8570, Japan
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Sapporo, Hokkaido, 064-0807, Japan
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Sapporo, Hokkaido, 064-8570, Japan
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Sapporo, Hokkaido, 065-0027, Japan
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Sapporo, Hokkaido, 065-0033, Japan
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Sapporo, Hokkaido, 065-8611, Japan
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Sunagawa, Hokkaido, 073-0196, Japan
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Tomakomai, Hokkaido, 053-8506, Japan
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Kobe, Hyōgo, 651-0073, Japan
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Kobe, Hyōgo, 651-1145, Japan
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Kobe, Hyōgo, 652-0803, Japan
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Higashiibaraki, Ibaraki, 311-3193, Japan
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Hitachi, Ibaraki, 317-0077, Japan
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Jōsō, Ibaraki, 303-0016, Japan
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Kasama, Ibaraki, 309-1793, Japan
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Moriya, Ibaraki, 302-0112, Japan
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Namegata, Ibaraki, 311-3516, Japan
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Toride, Ibaraki, 302-0022, Japan
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Kanazawa, Ishikawa-ken, 920-8650, Japan
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Nomi, Ishikawa-ken, 923-1100, Japan
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Hanamaki, Iwate, 025-0075, Japan
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Morioka, Iwate, 020-0103, Japan
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Marugame, Kagawa-ken, 763-8502, Japan
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Takamatsu, Kagawa-ken, 760-0018, Japan
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Izumi, Kagoshima-ken, 899-0131, Japan
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Kagoshima, Kagoshima-ken, 891-0116, Japan
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Atsugi, Kanagawa, 243-8551, Japan
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Fujisawa, Kanagawa, 251-0041, Japan
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Fujisawa, Kanagawa, 251-8550, Japan
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Kamakura, Kanagawa, 247-8533, Japan
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Kawasaki, Kanagawa, 216-8511, Japan
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Yokohama, Kanagawa, 227-0046, Japan
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Yokohama, Kanagawa, 231-8682, Japan
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Yokohama, Kanagawa, 236-0037, Japan
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Yokohama, Kanagawa, 236-0051, Japan
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Nangoku, Kochi, 783-8509, Japan
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Kumamoto, Kumamoto, 860-0008, Japan
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Kyoto, Kyoto, 602-8026, Japan
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Uji, Kyoto, 611-0042, Japan
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Kuwana, Mie-ken, 511-0068, Japan
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Sendai, Miyagi, 980-0803, Japan
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Sendai, Miyagi, 981-3107, Japan
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Sendai, Miyagi, 983-0821, Japan
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Sendai, Miyagi, 983-8512, Japan
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Sendai, Miyagi, 983-8520, Japan
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Komoro, Nagano, 384-8588, Japan
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Matsumoto, Nagano, 390-8510, Japan
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Suwa, Nagano, 392-8510, Japan
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Nagasaki, Nagasaki, 850-8555, Japan
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Jōetsu, Niigata, 949-3193, Japan
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Nagaoka, Niigata, 940-8621, Japan
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Beppu, Oita Prefecture, 874-0011, Japan
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Beppu, Oita Prefecture, 874-0901, Japan
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Ōita, Oita Prefecture, 870-0021, Japan
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Ōita, Oita Prefecture, 870-0192, Japan
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Ōita, Oita Prefecture, 870-0263, Japan
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Ōita, Oita Prefecture, 870-0917, Japan
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Yufu, Oita Prefecture, 879-5593, Japan
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Kasaoka, Okayama-ken, 714-0043, Japan
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Okayama, Okayama-ken, 700-8558, Japan
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Okayama, Okayama-ken, 700-8607, Japan
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Okinawa, Okinawa, 904-8585, Japan
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Shimajiri, Okinawa, 901-0493, Japan
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Daitō, Osaka, 574-0074, Japan
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Higashiosaka, Osaka, 578-8588, Japan
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Hirakata, Osaka, 573-0153, Japan
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Hirakata, Osaka, 573-8511, Japan
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Kawachi-Nagano, Osaka, 586-8521, Japan
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Kishiwada, Osaka, 596-8522, Japan
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Osaka, Osaka, 530-0001, Japan
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Osaka, Osaka, 530-8480, Japan
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Osaka, Osaka, 537-0011, Japan
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Osaka, Osaka, 540-0006, Japan
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Osaka, Osaka, 558-0011, Japan
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Osaka, Osaka, 558-8558, Japan
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Takatsuki, Osaka, 569-1096, Japan
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Toyonaka, Osaka, 560-0022, Japan
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Yao, Osaka, 581-0011, Japan
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Hanyū, Saitama, 348-8505, Japan
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Kasukage, Saitama, 344-0035, Japan
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Kitamoto, Saitama, 364-8501, Japan
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Tokorozawa, Saitama, 359-1141, Japan
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Tokorozawa, Saitama, 359-1142, Japan
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Wako, Saitama, 351-0102, Japan
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Kusatsu, Shiga, 525-8585, Japan
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Fujinomiya, Shizuoka, 418-0076, Japan
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Fukuroi, Shizuoka, 437-0061, Japan
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Hamamatsu, Shizuoka, 432-8580, Japan
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Hamamatsu, Shizuoka, 433-8558, Japan
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Iwata, Shizuoka, 438-8550, Japan
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Shimada, Shizuoka, 427-8502, Japan
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Shizuoka, Shizuoka, 421-0193, Japan
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Shizuoka, Shizuoka, 422-8527, Japan
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Shizuoka, Shizuoka, 424-8636, Japan
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Narutochō-mitsuishi, Tokushima, 772-8503, Japan
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Tokushima, Tokushima, 770-0011, Japan
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Edogawa-ku, Tokyo, 133-0052, Japan
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Hachiōji, Tokyo, 192-0045, Japan
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Higashikurume, Tokyo, 203-0033, Japan
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Itabashi-ku, Tokyo, 173-8610, Japan
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Itabashi-ku, Tokyo, 175-0082, Japan
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Meguro-ku, Tokyo, 153-8515, Japan
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Ōta-ku, Tokyo, 145-0065, Japan
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Shibuya-ku, Tokyo, 150-0013, Japan
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Shinagawa-ku, Tokyo, 141-0001, Japan
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Shinjuku-ku, Tokyo, 162-8655, Japan
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Tottori-shi, Tottori, 689-0203, Japan
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Toyama, Toyama, 930-0194, Japan
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Wakayama, Wakayama, 640-8505, Japan
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Higashikawada, Yamagata, 999-7782, Japan
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Shimonoseki, Yamaguchi, 750-0061, Japan
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Shūnan, Yamaguchi, 745-8522, Japan
Related Publications (11)
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.
PMID: 22664783RESULTChan 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.
PMID: 23052711RESULTTanahashi 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.
PMID: 23352688RESULTHori 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.
PMID: 23229461RESULTTanigawa 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.
PMID: 22813718RESULTKaneko 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.
PMID: 23337693RESULTMatsumoto 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.
PMID: 24477179RESULTUchiyama 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.
PMID: 24189454RESULTHori 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.
PMID: 23954611RESULTHori 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.
PMID: 23903065RESULTHori 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.
PMID: 24705469RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- BAYER
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 29, 2007
First Posted
July 2, 2007
Study Start
June 1, 2007
Primary Completion
December 1, 2009
Study Completion
January 1, 2010
Last Updated
April 20, 2015
Results First Posted
April 19, 2012
Record last verified: 2015-04