AzTrials
AzTrials

Atrial FibrillationPhase 3NCT00494871

Efficacy and Safety of Rivaroxaban for the Prevention of Stroke in Subjects With Non-Valvular Atrial Fibrillation

A Phase 3 study testing Rivaroxaban (Xarelto, BAY59-7939) and Warfarin in people with Atrial Fibrillation, run by Bayer at 165 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Atrial Fibrillation
What is being tested?
Rivaroxaban (Xarelto, BAY59-7939) and Warfarin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,280 participants
Where
165 sitesJapan
Study dates
Jun 2007to Jan 2010
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Significant mitral stenosis
  • Patients in whom anticoagulants are contraindicated

Trial locations and contacts

165 sites in 1 country.

165 sites in 1 country

Japan165 sites

  • Study site

    Asahi, Chiba, 289-2511

  • Study site

    Asahikawa, Hokkaido, 078-8214

  • Study site

    Atsugi, Kanagawa, 243-8551

  • Study site

    Beppu, Oita Prefecture, 874-0011

  • Study site

    Beppu, Oita Prefecture, 874-0901

  • Study site

    Chikushi-gun, Fukuoka, 811-1244

  • Study site

    Chikushino-shi, Fukuoka, 818-8502

  • Study site

    Chikushino-shi, Fukuoka, 818-8516

  • Study site

    Chitose, Hokkaido, 066-0034

  • Study site

    Daitō, Osaka, 574-0074

  • Study site

    Edogawa-ku, Tokyo, 133-0052

  • Study site

    Fujinomiya, Shizuoka, 418-0076

  • Study site

    Fujisawa, Kanagawa, 251-0041

  • Study site

    Fujisawa, Kanagawa, 251-8550

  • Study site

    Fukui-shi, Fukui, 910-0067

  • Study site

    Fukuoka, Fukuoka, 810-8563

  • Study site

    Fukuoka, Fukuoka, 811-0213

  • Study site

    Fukuoka, Fukuoka, 813-0044

  • Study site

    Fukuoka, Fukuoka, 814-0180

  • Study site

    Fukuroi, Shizuoka, 437-0061

  • Study site

    Funabashi, Chiba, 274-8503

  • Study site

    Gifu, Gifu, 500-8225

  • Study site

    Goshogawara, Aomori, 037-0053

  • Study site

    Hachiōji, Tokyo, 192-0045

  • Study site

    Hakodate, Hokkaido, 040-8611

  • Study site

    Hamamatsu, Shizuoka, 432-8580

  • Study site

    Hamamatsu, Shizuoka, 433-8558

  • Study site

    Hanamaki, Iwate, 025-0075

  • Study site

    Hanyū, Saitama, 348-8505

  • Study site

    Higashiibaraki, Ibaraki, 311-3193

  • Study site

    Higashikawada, Yamagata, 999-7782

  • Study site

    Higashikurume, Tokyo, 203-0033

  • Study site

    Higashiosaka, Osaka, 578-8588

  • Study site

    Hirakata, Osaka, 573-0153

  • Study site

    Hirakata, Osaka, 573-8511

  • Study site

    Hirosaki, Aomori, 036-8082

  • Study site

    Hirosaki, Aomori, 036-8545

  • Study site

    Hitachi, Ibaraki, 317-0077

  • Study site

    Imabari, Ehime, 799-1592

  • Study site

    Imba, Chiba, 270-1694

  • Study site

    Iwata, Shizuoka, 438-8550

  • Study site

    Izumi, Kagoshima-ken, 899-0131

  • Study site

    Jōetsu, Niigata, 949-3193

  • Study site

    Jōsō, Ibaraki, 303-0016

  • Study site

    Kagoshima, Kagoshima-ken, 891-0116

  • Study site

    Kamakura, Kanagawa, 247-8533

  • Study site

    Kanazawa, Ishikawa-ken, 920-8650

  • Study site

    Kasama, Ibaraki, 309-1793

  • Study site

    Kasaoka, Okayama-ken, 714-0043

  • Study site

    Kasuga, Fukuoka, 816-0833

  • Study site

    Kasuga, Fukuoka, 816-0864

  • Study site

    Kasugai, Aichi-ken, 487-0013

  • Study site

    Kasukage, Saitama, 344-0035

  • Study site

    Kawachi-Nagano, Osaka, 586-8521

  • Study site

    Kawasaki, Kanagawa, 216-8511

  • Study site

    Kishiwada, Osaka, 596-8522

  • Study site

    Kitakyushu, Fukuoka, 800-0057

  • Study site

    Kitakyushu, Fukuoka, 806-8501

  • Study site

    Kitamoto, Saitama, 364-8501

  • Study site

    Kobe, Hyōgo, 651-0073

  • Study site

    Kobe, Hyōgo, 651-1145

  • Study site

    Kobe, Hyōgo, 652-0803

  • Study site

    Komoro, Nagano, 384-8588

  • Study site

    Kōriyama, Fukushima, 963-8052

  • Study site

    Kumamoto, Kumamoto, 860-0008

  • Study site

    Kurume, Fukuoka, 830-8577

  • Study site

    Kusatsu, Shiga, 525-8585

  • Study site

    Kuwana, Mie-ken, 511-0068

  • Study site

    Kyoto, Kyoto, 602-8026

  • Study site

    Maebashi, Gunma, 371-8511

  • Study site

    Marugame, Kagawa-ken, 763-8502

  • Study site

    Matsudo, Chiba, 270-2251

  • Study site

    Matsudo, Chiba, 271-0077

  • Study site

    Matsumoto, Nagano, 390-8510

  • Study site

    Matsuyama, Ehime, 790-0024

  • Study site

    Matsuyama, Ehime, 790-0925

  • Study site

    Matsuyama, Ehime, 791-8026

  • Study site

    Mebashi, Gunma, 371-0014

  • Study site

    Meguro-ku, Tokyo, 153-8515

  • Study site

    Morioka, Iwate, 020-0103

  • Study site

    Moriya, Ibaraki, 302-0112

  • Study site

    Muroran, Hokkaido, 051-8501

  • Study site

    Nagaoka, Niigata, 940-8621

  • Study site

    Nagasaki, Nagasaki, 850-8555

  • Study site

    Nagoya, Aichi-ken, 453-8511

  • Study site

    Nagoya, Aichi-ken, 454-8502

  • Study site

    Nagoya, Aichi-ken, 455-8530

  • Study site

    Nagoya, Aichi-ken, 457-8510

  • Study site

    Nagoya, Aichi-ken, 462-0825

  • Study site

    Namegata, Ibaraki, 311-3516

  • Study site

    Nangoku, Kochi, 783-8509

  • Study site

    Narutochō-mitsuishi, Tokushima, 772-8503

  • Study site

    Niihama, Ehime, 792-8543

  • Study site

    Nomi, Ishikawa-ken, 923-1100

  • Study site

    Ōgaki, Gifu, 503-8502

  • Study site

    Ogōri, Fukuoka, 838-0141

  • Study site

    Ōita, Oita Prefecture, 870-0021

  • Study site

    Ōita, Oita Prefecture, 870-0192

  • Study site

    Ōita, Oita Prefecture, 870-0263

  • Study site

    Ōita, Oita Prefecture, 870-0917

  • Study site

    Okayama, Okayama-ken, 700-8558

  • Study site

    Okayama, Okayama-ken, 700-8607

  • Study site

    Okazaki, Aichi-ken, 444-8553

  • Study site

    Okinawa, Okinawa, 904-8585

  • Study site

    Osaka, Osaka, 530-0001

  • Study site

    Osaka, Osaka, 530-8480

  • Study site

    Osaka, Osaka, 537-0011

  • Study site

    Osaka, Osaka, 540-0006

  • Study site

    Osaka, Osaka, 558-0011

  • Study site

    Osaka, Osaka, 558-8558

  • Study site

    Ōta-ku, Tokyo, 145-0065

  • Study site

    Ōtake, Hiroshima, 739-0696

  • Study site

    Otaru, Hokkaido, 047-8510

  • Study site

    Saijō, Ehime, 793-0030

  • Study site

    Sapporo, Hokkaido, 004-0052

  • Study site

    Sapporo, Hokkaido, 060-0033

  • Study site

    Sapporo, Hokkaido, 060-0061

  • Study site

    Sapporo, Hokkaido, 060-8570

  • Study site

    Sapporo, Hokkaido, 064-0807

  • Study site

    Sapporo, Hokkaido, 064-8570

  • Study site

    Sapporo, Hokkaido, 065-0027

  • Study site

    Sapporo, Hokkaido, 065-0033

  • Study site

    Sapporo, Hokkaido, 065-8611

  • Study site

    Sendai, Miyagi, 980-0803

  • Study site

    Sendai, Miyagi, 981-3107

  • Study site

    Sendai, Miyagi, 983-0821

  • Study site

    Sendai, Miyagi, 983-8512

  • Study site

    Sendai, Miyagi, 983-8520

  • Study site

    Shibuya-ku, Tokyo, 150-0013

  • Study site

    Shimada, Shizuoka, 427-8502

  • Study site

    Shimajiri, Okinawa, 901-0493

  • Study site

    Shimonoseki, Yamaguchi, 750-0061

  • Study site

    Shinagawa-ku, Tokyo, 141-0001

  • Study site

    Shinjuku-ku, Tokyo, 162-8655

  • Study site

    Shizuoka, Shizuoka, 421-0193

  • Study site

    Shizuoka, Shizuoka, 422-8527

  • Study site

    Shizuoka, Shizuoka, 424-8636

  • Study site

    Shūnan, Yamaguchi, 745-8522

  • Study site

    Sunagawa, Hokkaido, 073-0196

  • Study site

    Suwa, Nagano, 392-8510

  • Study site

    tabashi City, Tokyo, 173-8610

  • Study site

    tabashi City, Tokyo, 175-0082

  • Study site

    Takamatsu, Kagawa-ken, 760-0018

  • Study site

    Takatsuki, Osaka, 569-1096

  • Study site

    Tokorozawa, Saitama, 359-1141

  • Study site

    Tokorozawa, Saitama, 359-1142

  • Study site

    Tokushima, Tokushima, 770-0011

  • Study site

    Tomakomai, Hokkaido, 053-8506

  • Study site

    Tōon, Ehime, 791-0281

  • Study site

    Toride, Ibaraki, 302-0022

  • Study site

    Tottori-shi, Tottori, 689-0203

  • Study site

    Toyama, Toyama, 930-0194

  • Study site

    Toyonaka, Osaka, 560-0022

  • Study site

    Uji, Kyoto, 611-0042

  • Study site

    Wakayama, Wakayama, 640-8505

  • Study site

    Wako, Saitama, 351-0102

  • Study site

    Yame, Fukuoka, 834-0004

  • Study site

    Yame, Fukuoka, 834-0006

  • Study site

    Yao, Osaka, 581-0011

  • Study site

    Yokohama, Kanagawa, 227-0046

  • Study site

    Yokohama, Kanagawa, 231-8682

  • Study site

    Yokohama, Kanagawa, 236-0037

  • Study site

    Yokohama, Kanagawa, 236-0051

  • Study site

    Yotsukaidō, Chiba, 284-0032

  • Study site

    Yufu, Oita Prefecture, 879-5593

Other trials in Japan

About this study

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

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

Read the detailed description

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

Being tested
Rivaroxaban (Xarelto, BAY59-7939), Warfarin, Rivaroxaban placebo, Warfarin placebo
Keywords
BAY59-7939, Rivaroxaban, Non-Valvular Atrial Fibrillation, Japanese Patients, Phase III, 12620
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rivaroxaban (Xarelto, BAY59-7939)Drug

    Participants orally administered rivaroxaban 15 mg OD (CrCL [creatinine clearance] >= 50 mL/min) or 10 mg OD (CrCL 30-49 mL/min)

  • WarfarinDrug

    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)

  • Rivaroxaban placeboDrug

    Participants orally administered a rivaroxaban placebo tablet

  • Warfarin placeboDrug

    Participants orally administered a warfarin placebo tablet (adjusted based upon sham INR values)

Study groups in NCT00494871
Study groupRoleWhat they receive
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
Receives: Drug: Rivaroxaban (Xarelto, BAY59-7939); Drug: Warfarin placebo
WarfarinActive comparatorParticipants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
Receives: Drug: Warfarin; Drug: Rivaroxaban placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 2 days after the last dose

Secondary outcomes (11)

  1. Event Rate of the Composite Endpoint of Adjudicated Stroke and Non-central Nervous System (CNS) Systemic Embolism

    This is the principal efficacy endpoint. Stroke included hemorrhagic, ischemic infarction and unknown. Arterial emboli in the following areas were "non-CNS systemic embolism": peripheral arterial in the upper and lower extremities, renal, mesenteric, splenic, hepatic, ocular/retinal and others. Pulmonary embolism or myocardial infarction was excluded.

    Measured: Up to 2 days after the last dose

  2. Event Rate of the Composite Endpoint of Adjudicated Stroke, Non-CNS Systemic Embolism, and Vascular Death

    Stroke included hemorrhagic, ischemic infarction and unknown. Arterial emboli in the following areas were "non-CNS systemic embolism": peripheral arterial in the upper and lower extremities, renal, mesenteric, splenic, hepatic, ocular/retinal and others. Pulmonary embolism or myocardial infarction was excluded. Any death that was not clearly non-vascular.

    Measured: Up to 2 days after the last dose

  3. Event Rate of the Composite Endpoint of Adjudicated Stroke, Non-CNS Systemic Embolism, Myocardial Infarction, and Vascular Death

    Stroke included hemorrhagic, ischemic infarction and unknown. Arterial emboli in the following areas were "non-CNS systemic embolism": peripheral arterial in the upper and lower extremities, renal, mesenteric, splenic, hepatic, ocular/retinal and others. Pulmonary embolism or myocardial infarction was excluded. Myocardial infarction: assessed based on either cardiac biomarkers, new abnormal Q waves appeared on electrocardiogram for ≥2 leads, or autopsy confirmation. Any death that was not clearly non-vascular.

    Measured: Up to 2 days after the last dose

  4. Event Rate of Stroke

    All events were adjudicated and confirmed by a central independent committee blinded to treatment. Stroke included hemorrhagic (Stroke with local collections of intraparenchymal blood. Subarachnoid hemorrhage, subdural hemorrhage, and epidural hemorrhage were excluded.), ischemic infarction (Stroke without focal collection of intracranial blood) and unknown (No imaging data and anatomic findings were available.).

    Measured: Up to 2 days after the last dose

  5. Event Rate of Non-CNS Systemic Embolism

    All events were adjudicated and confirmed by a central independent committee blinded to treatment. Non-CNS systemic embolism was abrupt vascular insufficiency associated with clinical or radiological evidence of arterial occlusion in the absence of other likely mechanisms (such as trauma, atherosclerosis, and instrumentation). Arterial emboli in the following areas were "non-CNS systemic embolism": peripheral arterial in the upper and lower extremities, renal, mesenteric, splenic, hepatic, ocular/retinal and others. Pulmonary embolism or myocardial infarction was excluded from this category.

    Measured: Up to 2 days after the last dose

  6. Event Rate of Myocardial Infarction

    All events were adjudicated and confirmed by a central independent committee blinded to treatment. Myocardial infarction was assessed based on either cardiac bio-markers (troponin I, troponin T, or creatine kinase-muscle and brain subunit isozyme), new abnormal Q waves appeared on ECG for 2 or more leads, or autopsy confirmation.

    Measured: Up to 2 days after the last dose

  7. Event Rate of Vascular Death

    All events were adjudicated and confirmed by a central independent committee blinded to treatment. Any death that was not clearly non-vascular (e.g., deaths due to spontaneous bleeding, myocardial infarction, stroke, cardiac failure, and arrhythmia)

    Measured: Up to 2 days after the last dose

  8. Event Rate of Stroke With Serious Residual Disability

    All events were adjudicated and confirmed by a central independent committee blinded to treatment. A stroke was considered disabling if the participant's modified Rankin score was between 3 and 5, inclusive.

    Measured: Up to 2 days after the last dose

  9. Event Rate of All-cause Death

    All events were adjudicated and confirmed by a central independent committee blinded to treatment. All-cause death included vascular death and non-vascular death.

    Measured: Up to 2 days after the last dose

  10. Event Rate of Adjudicated Major Bleeding

    All events were adjudicated and confirmed by a central independent committee blinded to treatment. Major bleeding was clinically overt bleeding associated with a fall in hemoglobin of 2 g/dL or higher, leading to a transfusion of 2 or more units of packed red blood cells or whole blood, occurring in a critical site or contributing to death.

    Measured: Up to 2 days after the last dose

  11. Event Rate Adjudicated Non-major Clinically Relevant Bleeding

    All events were adjudicated and confirmed by a central independent committee blinded to treatment. Non-major clinically relevant bleeding was clinically overt bleeding 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.

    Measured: Up to 2 days after the last dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2007 (estimated)
  2. Study startJun 2007
  3. Primary completionDec 2009
  4. Study completionJan 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
1,280 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00494871
Sponsor's protocol ID
12620
Status last verified
Apr 2015
First submitted
29 Jun 2007
Last updated
20 Apr 2015
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 22664783

  • 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.

    PubMed 23052711

  • 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.

    PubMed 23352688

  • 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.

    PubMed 23229461

  • 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.

    PubMed 22813718

  • 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.

    PubMed 23337693

  • 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.

    PubMed 24477179

  • 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.

    PubMed 24189454

  • 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.

    PubMed 23954611

  • 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.

    PubMed 23903065

  • 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.

    PubMed 24705469

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rivaroxaban (Xarelto, BAY59-7939) and Warfarin in people with Atrial Fibrillation, run by Bayer at 165 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 165 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Apr 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Event Rate of the Composite Endpoint of Adjudicated Major Bleeding or Adjudicated Non-major Clinically Relevant Bleeding (time frame: Up to 2 days after the last dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00494871, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2015.

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