Study Completed

Atrial Fibrillation

Bayer Identifier:

12620

ClinicalTrials.gov Identifier:

NCT00494871

EudraCT Number:

Not Available

EU CT Number:

Not Available

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

Trial purpose

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

Key Participants Requirements

Sex

Both

Age

20 Years

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

Trial summary

Enrollment Goal

1280

Trial Dates

June 2007 - January 2010

Phase

Phase 3

Could I Receive a placebo

Products

Xarelto (Rivaroxaban, BAY59-7939)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	Kihara Cardiovascular and Internal Hospital	Asahikawa, 078-8214, Japan
Completed	Nikko Memorial Hospital	Muroran, 051-8501, Japan
Completed	Hakodate Goryoukaku Hospital	Hakodate, 040-8611, Japan
Completed	Seihoku Chuo Hospital	Goshogawara, 037-0053, Japan
Completed	General Hanamaki Hospital	Hanamaki, 025-0075, Japan
Completed	Sendai East Neurosurgical Hospital	Sendai, 983-0821, Japan
Completed	Tohoku Kosai Hospital	Sendai, 980-0803, Japan
Completed	Namegata District General Hospital	Namegata, 311-3516, Japan
Completed	Kinu Medical Association Hospital	Joso, 303-0016, Japan
Completed	Maebashi Red Cross Hospital	Mebashi, 371-0014, Japan
Completed	Saitama National Hospital	Wako, 351-0102, Japan
Completed	Kitasato University Medeical Center	Kitamoto, 364-8501, Japan
Completed	Saino Clinic	Tokorozawa, 359-1141, Japan
Completed	Asahi Central Hospital	Asahi, 289-2511, Japan
Completed	Kitahara Neurosurgical Institute	Hachioji, 192-0045, Japan
Completed	Tenshi Hospital	Sapporo, 065-8611, Japan
Completed	Sapporo Minami-ichijo Hospital	Sapporo, 060-0061, Japan
Completed	Miyanomori Memorial Hospital	Sapporo, 064-8570, Japan
Completed	Oji General Hospital	Tomakomai, 053-8506, Japan
Completed	Sendai Medical Center	Sendai, 983-8520, Japan
Completed	Mito Medical Center	Higashiibaraki, 311-3193, Japan
Completed	Ibaraki Prefectural Central Hospital	Kasama, 309-1793, Japan
Completed	Aida Kinen Rehabilitation Hospital	Moriya, 302-0112, Japan
Completed	Tokorozawa Heart Center	Tokorozawa, 359-1142, Japan
Completed	Itabashi Medical Association Hospital	Itabashi-ku, 175-0082, Japan
Completed	Tokyo Heart Center	Shinagawa-ku, 141-0001, Japan
Completed	Kanagawa Cardiovascular and Respiratory Center	Yokohama, 236-0051, Japan
Completed	Tachikawa General Hospital	Nagaoka, 940-8621, Japan
Completed	Toyama University Hospital	Toyama, 930-0194, Japan
Completed	Suwa Red Cross Hospital	Suwa, 392-8510, Japan
Completed	Saigata National Hospital	Joetsu, 949-3193, Japan
Completed	Komoro Kosei General Hospital	Komoro, 384-8588, Japan
Completed	Ogaki Municipal Hospital	Ogaki, 503-8502, Japan
Terminated	Fukuroi Municipal Hospital	Fukuroi, 437-0061, Japan
Completed	Seirei Mikatahara General Hospital	Hamamatsu, 433-8558, Japan
Completed	Social Insurance Chukyo Hospital	Nagoya, 457-8510, Japan
Completed	Nagoya Ekisaikai Hospital	Nagoya, 454-8502, Japan
Completed	Kanazawa Medical Center	Kanazawa, 920-8650, Japan
Completed	Takatsuki Red Cross Hospital	Takatsuki, 569-1096, Japan
Completed	Sakurabashi Watanabe Hospital	Osaka, 530-0001, Japan
Completed	Higashiosaka City General Hospital	Higashiosaka, 578-8588, Japan
Completed	Osaka-Minami Medical Center	Kawachinagano, 586-8521, Japan
Completed	Yoshida Hospital	Kobe, 652-0803, Japan
Completed	Japanese Red Cross Okayama Hospital	Okayama, 700-8607, Japan
Completed	Ehime National Hospital	Toon, 791-0281, Japan
Completed	Sumitomo Besshi Hospital	Niihama, 792-8543, Japan
Completed	Fujinomiya City General Hospital	Fujinomiya, 418-0076, Japan
Completed	Iwata City Hospital	Iwata, 438-8550, Japan
Completed	Shimada Municipal Hospital	Shimada, 427-8502, Japan
Completed	Nagoya Daiichi Red Cross Hospital	Nagoya, 453-8511, Japan
Completed	Kuwana City Hospital-Branch Hospital	Kuwana, 511-0068, Japan
Completed	Houju Kinen Hospital	Nomi, 923-1100, Japan
Completed	Tsushima Clinic	Toyonaka, 560-0022, Japan
Completed	Hanwa Memorial Hospital	Osaka, 558-0011, Japan
Completed	Kobe Red Cross Hospital	Kobe, 651-0073, Japan
Completed	Tottori Medical Center	Tottori, 689-0203, Japan
Completed	Health insurance Naruto Hospital	Naruto, 772-8503, Japan
Completed	Kawashima Cardiovascular Clinic	Tokushima, 770-0011, Japan
Completed	Ehime Prefectural Central Hospital	Matsuyama, 790-0024, Japan
Completed	Murakami Kinen Hospital	Saijo, 793-0030, Japan
Completed	Imabari Hospital	Imabari, 799-1592, Japan
Completed	Kyushu Kosei Nenkin Hospital	Kitakyushu, 806-8501, Japan
Completed	Go Neurosurgery Clinic	Chikushi-gun, 811-1244, Japan
Completed	Shinkoga Hospital	Kurume, 830-8577, Japan
Completed	Kumamoto Medical Center	Kumamoto, 860-0008, Japan
Completed	Hashino Department of Circulatory System Internal Medicine	Kagoshima, 891-0116, Japan
Completed	Shonai Amarume Hospital	Higashikawada, 999-7782, Japan
Completed	Chiba Tokushukai Hospital	Funabashi, 274-8503, Japan
Completed	Shonan Kamakura General Hospital	Kamakura, 247-8533, Japan
Completed	Shonan Fujisawa Tokushukai Hospital	Fujisawa, 251-0041, Japan
Completed	Shizuoka Tokushukai Hospital	Shizuoka, 421-0193, Japan
Completed	Nagoya Tokushukai Genaral Hospital	Kasugai, 487-0013, Japan
Completed	Uji Tokushukai Hospital	Uji, 611-0042, Japan
Completed	Nozaki Tokushukai Hospital	Daito, 574-0074, Japan
Completed	Kishiwada Tokushukai Hospital	Kishiwada, 596-8522, Japan
Completed	Kasaoka Daiichi Hospital	Kasaoka, 714-0043, Japan
Completed	Hirakata kohsai Hospital	Hirakata, 573-0153, Japan
Completed	Yame Rihabiri Hospital	Yame, 834-0006, Japan
Completed	Shinkomonji Hospital	Kitakyushu, 800-0057, Japan
Completed	Fukuoka Wajiro Hospital	Fukuoka, 811-0213, Japan
Completed	Fukuoka University Hospital	Fukuoka, 814-0180, Japan
Completed	Fukuoka University Chikushi Hospital	Chikushino, 818-8502, Japan
Completed	Shimada Hospital	Ogori, 838-0141, Japan
Completed	Yano Cardiovascular Medicine Intarnal Medicine Clinic	Fukuoka, 813-0044, Japan
Completed	Higuchi Hospital	Kasuga, 816-0833, Japan
Completed	Nagasaki Municipal Hospital	Nagasaki, 850-8555, Japan
Completed	Nakamura Memorial Hospital	Sapporo, 060-8570, Japan
Completed	Oita Medical Center	Oita, 870-0263, Japan
Completed	Fukuoka Tokushukai Medical Center	Kasuga, 816-0864, Japan
Completed	ChubuTokushukai Hospital	Okinawa, 904-8585, Japan
Completed	Izumi Medical Center	Izumi, 899-0131, Japan
Completed	Takanoko Hospital	Matsuyama, 790-0925, Japan
Completed	Chibanishi General Hospital	Matsudo, 270-2251, Japan
Completed	Kitano Hospital	Osaka, 530-8480, Japan
Completed	Wakayama Rosai Hospital	Wakayama, 640-8505, Japan
Completed	Riverside Clinic	Sapporo, 064-0807, Japan
Completed	Chitose Houyukai Hospital	Chitose, 066-0034, Japan
Completed	Hirosaki National Hospital	Hirosaki, 036-8545, Japan
Completed	Toho University Ohashi Medical Center	Meguro-ku, 153-8515, Japan
Completed	Fukui General Clinic	Fukui, 910-0067, Japan
Completed	Shizuoka City Shimizu Hospital	Shizuoka, 424-8636, Japan
Completed	KKR Takamatsu Hospital	Takamatsu, 760-0018, Japan
Completed	Oita University Hospital	Yufu, 879-5593, Japan
Completed	Matsuzono Second Hospital	Morioka, 020-0103, Japan
Completed	Nanbu Tokushukai Hospital	Shimajiri, 901-0493, Japan
Completed	Saiseikai Futsukaichi Hospital	Chikushino, 818-8516, Japan
Completed	Ebara Hospital	Ota-ku, 145-0065, Japan
Completed	Kusatsu General Hospital	Kusatsu, 525-8585, Japan
Completed	Otaru Hospital	Otaru, 047-8510, Japan
Completed	Hoshigaoka Koseinenkin Hospital	Hirakata, 573-8511, Japan
Completed	Aizawa Hospital	Matsumoto, 390-8510, Japan
Completed	Kyoto Second Red Cross Hospital	Kyoto, 602-8026, Japan
Completed	Osaka General Medical Center	Osaka, 558-8558, Japan
Completed	Sunagawa City Medical Center	Sunagawa, 073-0196, Japan
Completed	Chubu Rosai Hospital	Nagoya, 455-8530, Japan
Completed	Hiroshima-Nishi Medical Center	Otake, 739-0696, Japan
Completed	Osaka National Hospital	Osaka, 540-0006, Japan
Completed	Sendai Cardiovascular Center	Sendai, 981-3107, Japan
Completed	Hitachi General Hospital	Hitachi, 317-0077, Japan
Completed	Nippon Medical School Chiba Hokusoh Hospital	Imba, 270-1694, Japan
Completed	Yotsukaidou Tokushukai Hospital	Yotsukaido, 284-0032, Japan
Completed	Yokohama Minami Kyousai Hospital	Yokohama, 236-0037, Japan
Completed	Shonan Atsugi Hospital	Atsugi, 243-8551, Japan
Completed	Saiseikai Matsuyama Hospital	Matsuyama, 791-8026, Japan
Completed	Inoue Cardiovascular Clinic	Oita, 870-0917, Japan
Completed	Hanyu General Hospital	Hanyu, 348-8505, Japan
Completed	Tachibanadai Hospital	Yokohama, 227-0046, Japan
Completed	Tohoku KoseiNenkin Hospital	Sendai, 983-8512, Japan
Completed	Tokuyama Central Hospital	Shunan, 745-8522, Japan
Completed	Inobefunai Clinic	Oita, 870-0021, Japan
Completed	Yokohama City Minato Red Cross Hospital	Yokohama, 231-8682, Japan
Completed	National Center for Global Health and Medicine Hospital	Shinjuku-ku, 162-8655, Japan
Completed	Shakaihoken Kobe Central Hospital	Kobe, 651-1145, Japan
Completed	JA Kochi Hospital	Nangoku, 783-8509, Japan
Completed	Kagawa Rosai Hospital	Marugame, 763-8502, Japan
Completed	Okayama University Hospital	Okayama, 700-8558, Japan
Completed	St. Marianna University of School Medicine Hospital	Kawasaki, 216-8511, Japan
Completed	Nihon University Itabashi Hospital	Itabashi-ku, 173-8610, Japan
Completed	Hashimoto Internal Medicine	Gifu, 500-8225, Japan
Completed	Hata Hospital	Beppu, 874-0901, Japan
Completed	Okazaki City Hospital	Okazaki, 444-8553, Japan
Completed	Sapporo Higashi Tokushukai Hospital	Sapporo, 065-0033, Japan
Completed	Shin-Sapporo Cardiological Hospital	Sapporo, 004-0052, Japan
Completed	Shuwa General Hospital	Kasukage, 344-0035, Japan
Completed	JR Sapporo Hospital	Sapporo, 060-0033, Japan
Completed	Shimonoseki Kosei Hospital	Shimonoseki, 750-0061, Japan
Completed	Beppu Medical Center	Beppu, 874-0011, Japan
Completed	Close To You EST Clinic	Hirosaki, 036-8082, Japan
Completed	Yagi Neurosurgery Hospital	Osaka, 537-0011, Japan
Completed	Oita Oka Hospital	Oita, 870-0192, Japan
Completed	Takiyama Hospital	Higashikurume, 203-0033, Japan
Completed	Hamamatsu Medical Center	Hamamatsu, 432-8580, Japan
Completed	Shin Tokyo Clinic	Matsudo, 271-0077, Japan
Completed	Kusaba Internal and CV Hp	Yame, 834-0004, Japan
Completed	Aishin Memorial Hospital	Sapporo, 065-0027, Japan
Completed	Shizuoka Saiseikai General Hospital	Shizuoka, 422-8527, Japan
Completed	Okuma Hospital	Nagoya, 462-0825, Japan
Completed	Gunma University Hospital	Maebashi, 371-8511, Japan
Completed	Tokyo Metoropolitan Hiroo Hospital	Shibuya-ku, 150-0013, Japan
Completed	Yao Tokushukai General Hospital	Yao, 581-0011, Japan
Completed	Medical Plaza Edogawa	Edogawa-ku, 133-0052, Japan
Completed	Fujisawa City Hospital	Fujisawa, 251-8550, Japan
Completed	Kyushu Medical Center	Fukuoka, 810-8563, Japan
Completed	JA Toride Medical Center	Toride, 302-0022, Japan
Completed	Southern Tohoku Medical Clinic	Koriyama, 963-8052, Japan

Primary Outcome

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
Safety Issue:
Yes

Secondary Outcome

Event rate of the composite endpoint of adjudicated stroke and non-central nervous system (CNS) systemic embolism
Time Frame:
Up to 2 days after the last dose
Safety Issue:
No
Event rate of the composite endpoint of adjudicated stroke, non-CNS systemic embolism, and vascular death
Time Frame:
Up to 2 days after the last dose
Safety Issue:
No
Event rate of the composite endpoint of adjudicated stroke, non-CNS systemic embolism, myocardial infarction, and vascular death
Time Frame:
Up to 2 days after the last dose
Safety Issue:
No
Event rate of stroke
Time Frame:
Up to 2 days after the last dose
Safety Issue:
No
Event rate of non-CNS systemic embolism
Time Frame:
Up to 2 days after the last dose
Safety Issue:
No
Event rate of myocardial infarction
Time Frame:
Up to 2 days after the last dose
Safety Issue:
No
Event rate of vascular death
Time Frame:
Up to 2 days after the last dose
Safety Issue:
No
Event rate of stroke with serious residual disability
Time Frame:
Up to 2 days after the last dose
Safety Issue:
No
Event rate of all-cause death
Time Frame:
Up to 2 days after the last dose
Safety Issue:
No
Event rate of adjudicated major bleeding
Time Frame:
Up to 2 days after the last dose
Safety Issue:
Yes
Event rate adjudicated non-major clinically relevant bleeding
Time Frame:
Up to 2 days after the last dose
Safety Issue:
Yes

Trial design

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

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Prevention

Allocation

Randomized

Blinding

Double Blind

Assignment

Parallel Assignment

Trial Arms

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to Bayer Healthcare products.