Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
984 participants
INTERVENTIONAL
2016-08-05
2019-12-27
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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DU-176b 15 mg group
DU-176b orally administered at a dose of 15 mg once daily.
Du-176b
DU-176b orally administered at a dose of 15 mg once daily.
Placebo group
Placebo orally administered once daily.
placebo
Placebo orally administered once daily.
Interventions
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Du-176b
DU-176b orally administered at a dose of 15 mg once daily.
placebo
Placebo orally administered once daily.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients who have poorly controlled hypertension
* Patients who have liver dysfunction accompanied with disorder of blood coagulation
80 Years
ALL
No
Sponsors
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Daiichi Sankyo Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Leader
Role: STUDY_DIRECTOR
Daiichi Sankyo
Locations
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Social Corporation Keigakukai Minamiosaka Hospital
Osaka, Osaka, Japan
Hakujikai Memorial Hospital
Adachi-ku, , Japan
Ageo Central General Hospital
Ageo, , Japan
Medical Corporation Aijinkai Akashi Medical Center
Akashi, , Japan
Ako City Hospital
Akō, , Japan
Amagasaki New Town Hospital
Amagasaki, , Japan
Anjo Kosei Hospital
Anjo, , Japan
Shin-Ai Kai Honda Hospital
Annaka, , Japan
Toyooka Chuo Hospital
Asahikawa, , Japan
Tokyo Medical and Dental University Medical Hospital
Bunkyō City, , Japan
Nippon Medical School Hospital
Bunkyō City, , Japan
Fukuokaken Saiseikai Futsukaichi Hospital
Chikushino-shi, , Japan
Aichi Koseiren Chita Kosei Hospital
Chita, , Japan
Kashinoki Internal Medicine Clinic
Date, , Japan
Medical Plaza Edogawa
Edagawa, , Japan
Fukui General Clinic
Fukui, , Japan
National Hospital Organization Kyushu Medical Center
Fukuoka, , Japan
Onga Nakama Medical Association Onga Hospital
Fukuoka, , Japan
Fukushima Daiichi Hospital
Fukushima, , Japan
Funabashi Municipal Medical Center
Funabashi, , Japan
Gifu Heart Center
Gifu, , Japan
Minamino Cardiovascular Hospital
Hachiōji, , Japan
Tokyo Tenshi Hospital
Hachiōji, , Japan
Social welfare corporation Hakodate koseiin Hakodate Goryoukaku Hospital
Hakodate, , Japan
National Hospital Organization Hakodate Hospital
Hakodate, , Japan
National Hospital Organization Hamada Medical Center
Hamada, , Japan
Hamamatsu Medical Center
Hamamatsu, , Japan
Okitama Public General Hospital
Higashinakama, , Japan
Social Medical Corporation, the Yamatokai Foundation Central Clinic affiliated clinic of Higashiyamato Hospital
Higashiyamato, , Japan
Hikone Municipal Hospital
Hikone, , Japan
Kanazawa Medical University Himi Municipal Hospital
Himi, , Japan
Hiratsuka kyosai Hospital
Hiratsuka, , Japan
Hirosaki Stroke and Rehabilitation Center
Hirosaki, , Japan
Local Independent Administrative Corporation Hiroshima City Hospital Organization Hiroshima City Hiroshima Citizens Hospital
Hiroshima, , Japan
National Hospital Organization Mito Medical Center
Ibaraki, , Japan
Nippon Medical School Chiba Hokusoh Hospital
Inzai, , Japan
Tokai University Hospital
Isehara, , Japan
Kubo Clinic
Isesaki, , Japan
Shimane University Hospital
Izumo, , Japan
National Hospital Organization Kagoshima Medical Center
Kagoshima, , Japan
National Hospital Organization Kanazawa Medical Center
Kanazawa, , Japan
Kasugai Municipal Hospital
Kasugai, , Japan
Asano Kanamachi Clinic
Katsushikachō, , Japan
Saiseikai Kawaguchi General Hospital
Kawaguchi, , Japan
St. Marianna University School of Medicine Hospital
Kawasaki, , Japan
Kitasato University Medical Center
Kitamoto, , Japan
Kobe Rosai Hospital
Kobe, , Japan
Nose Hospital
Kobe, , Japan
Medical Corporation Sakurakai Takahashi Hospital
Kobe, , Japan
Nakayama Clinic of Internal Medicine and Cardiology
Kochi, , Japan
Yamanashi Prefectural Central Hospital
Kofu, , Japan
Kanno Reism Heart Clinic
Kosugi-shiraishi, , Japan
Southern Tohoku Research Institute for Neuroscience, Southern Tohoku Medical Clinic
Kōriyama, , Japan
Hoshi General Hospital
Kōriyama, , Japan
Showa University Koto Toyosu Hospital
Kōtoku, , Japan
Koto Hospital
Kōtoku, , Japan
Saiseikai Kumamoto Hospital
Kumamoto, , Japan
Kure Kyosai Hospital
Kure, , Japan
Tanushimaru Central Hospital
Kurume, , Japan
Kusatsu General Hospital
Kusatsu, , Japan
Japanese Red Cross Kyoto Daini Hospital
Kyoto, , Japan
National Hospital Organization Kyoto Medical Center
Kyoto, , Japan
Machida Municipal Hospital
Machida, , Japan
National Hospital Organization Maizuru Medical Center
Maizuru, , Japan
New Tokyo Heart Clinic
Matsudo, , Japan
Matsue City Hospital
Matsue, , Japan
National Hospital Organization Matsumoto Medical Center
Matsumoto, , Japan
Matsuyama Red Cross Hospital
Matsuyama, , Japan
National Hospital Organization Tokyo Medical Center
Meguro-ku, , Japan
Miyazaki Medical Association Hospital
Miyazaki, , Japan
University of Miyazaki Hospital
Miyazaki, , Japan
Iwate Prefectural Central Hospital
Morioka, , Japan
Nagasaki Harbor Medical Center
Nagasaki, , Japan
Nagoya Ekisaikai Hospital
Nagoya, , Japan
Japanese Red Cross Nagoya Daini Hospital
Nagoya, , Japan
Ohama Daiichi Hospital
Naha, , Japan
Naha City Hospital
Naha, , Japan
Takanohara Central Hospital
Nara, , Japan
JCHO Nihonmatsu Hospital
Nihonmatsu, , Japan
Meiwa Hospital
Nishinomiya, , Japan
Ohyama Memorial Hospital
Nishiwaki, , Japan
Ogawa Cardiovascular Internal Medicine Clinic
Obihiro, , Japan
Shimada Hospital
Ogōri-shimogō, , Japan
Sakurabashi Watanabe Hospital
Osaka, , Japan
Osaka City Juso Hospital
Osaka, , Japan
Kitada Clinic
Osaka, , Japan
Osaka Police Hospital
Osaka, , Japan
Osaka General Medical Center
Osaka, , Japan
National Hospital Organization Osaka Minami Medical Center
Osaka, , Japan
Sato Hospital
Osaka, , Japan
Otaru Kyokai Hospital
Otaru, , Japan
Ogaki Municipal Hospital
Ōgaki, , Japan
Oita Prefectural Hospital
Ōita, , Japan
Kouhoukai Takagi Hospital
Ōkawa, , Japan
Ome Municipal General Hospital
Ōme, , Japan
Omihachiman Community Medical Center
Ōmihachiman, , Japan
National Hospital Organization Nagasaki Medical Center
Ōmura, , Japan
Omori Sanno Hospital
Ōta-ku, , Japan
JCHO Shiga Hospital
Ōtsu, , Japan
Saga-Ken Medical Centre Koseikan
Saga, , Japan
Saitama City Hospital
Saitama, , Japan
Saitama Memorial Hospital
Saitama, , Japan
Saku Central Hospital Advanced Care Center
Saku, , Japan
Kin-ikyo Chuo Hospital
Sapporo, , Japan
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
Sapporo, , Japan
National Hospital Organization Hokkaido Medical Center
Sapporo, , Japan
Sapporo Nishimaruyama Hospital
Sapporo, , Japan
Miyanomori Memorial Hospital
Sapporo, , Japan
Hokkaido Cardiovascular Hospital
Sapporo, , Japan
Shukokai Internal Medicine Sato Hospital
Sendai, , Japan
KKR Tohoku Kosai Hospital
Sendai, , Japan
National Hospital Organization Sendai Medical Center
Sendai, , Japan
Tosei General Hospital
Seto, , Japan
National Hospital Organization Kanmon Medical Center
Shimonoseki, , Japan
Dokkyo Medical University Hospital
Shimosuga, , Japan
Tokyo Heart Center
Shinagawa-Ku, , Japan
Showa University Hospital
Shinagawa-Ku, , Japan
Center Hospital of the National Center for Global Health and Medicine
Shinjuku-Ku, , Japan
Shirakawa Hospital
Shirakawa, , Japan
Iwate Medical University Hospital
Shiwa-gun, , Japan
National Hospital Organization Shizuoka Medical Center
Shizuoka, , Japan
Ikeda Kinen Hospital
Sukagawa, , Japan
Iwase General Hospital
Sukagawa, , Japan
Hyogo Prefectural Awaji Medical Center
Sumoto, , Japan
Nagano Prefectural Shinshu Medical Hospital
Suzaka, , Japan
National Hospital Organization Disaster Medical Center
Tachikawa, , Japan
Social Insurance Tagawa Hospital
Tagawa, , Japan
Kagawa Prefectural Central Hospital
Takamatsu, , Japan
Kouseiren Takaoka Hospital
Takaoka, , Japan
Medical Corporation Aishinkai Higashi Takarazuka Satoh Hospital
Takarazuka, , Japan
Kan-etsu Chu-oh Hospital
Takasaki, , Japan
Takatsuki General Hospital
Takatsuki, , Japan
National Hospital Organization Minami Wakayama Medical Center
Tanabe, , Japan
Tenri Hospital
Tenri, , Japan
Kuwanomi Hongou Clinic
Tokorozawa, , Japan
Saino Clinic
Tokorozawa, , Japan
Tokorozawa Heart Center
Tokorozawa, , Japan
Tokushima University Hospital
Tokushima, , Japan
Tokushima Prefectural Central Hospital
Tokushima, , Japan
Nerima General Hospital
Tokyo, , Japan
Tomakomai City Hospital
Tomakomai, , Japan
Public Tomioka General Hospital
Tomioka, , Japan
Yamaguchi Clinic
Toshima-ku, , Japan
Yayoigaoka Kage Hospital
Tosu, , Japan
National Hospital Organization Toyohashi Medical Center
Toyohashi, , Japan
TOYOTA Memorial Hospital
Toyota, , Japan
National Hospital Organization Ehime Medical Center
Tōon, , Japan
Tsukuba Memorial Hospital
Tsukuba, , Japan
Okinawa Prefectural Chubu Hospital
Uruma, , Japan
National Hospital Organization Tochigi Medical Center
Utsunomiya, , Japan
Uwajima City Hospital
Uwajima, , Japan
Wakayama Rosai Hospital
Wakayama, , Japan
Nagata Hospital
Yanagawa, , Japan
Kumamoto General Hospital
Yatsushiro, , Japan
Yokohama Municipal Citizen's Hospital
Yokohama, , Japan
Yokohama Rosai Hospital
Yokohama, , Japan
Showa University Fujigaoka Hospital
Yokohama, , Japan
JCHO Yokohama Chuo Hospital
Yokohama, , Japan
Yokohama City Minato Red Cross Hospital
Yokohama, , Japan
Yokohama City University Medical Center
Yokohama, , Japan
Saiseikai Yokohamashi Nanbu Hospital
Yokohama, , Japan
Yokohama Minami Kyousai Hospital
Yokohama, , Japan
National Hospital Organization Yokohama Medical Center
Yokohama, , Japan
Yokohama Sakae Kyosai Hospital
Yokohama, , Japan
Countries
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References
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Akao M, Yamashita T, Fukuzawa M, Hayashi T, Okumura K. Efficacy and Safety of Low-Dose Edoxaban by Body Weight in Very Elderly Patients With Atrial Fibrillation: A Subanalysis of the Randomized ELDERCARE-AF Trial. J Am Heart Assoc. 2024 Feb 6;13(3):e031506. doi: 10.1161/JAHA.123.031506. Epub 2024 Jan 19.
Cochrane A, Chen C, Stephen J, Ronning OM, Anderson CS, Hankey GJ, Al-Shahi Salman R. Antithrombotic treatment after stroke due to intracerebral haemorrhage. Cochrane Database Syst Rev. 2023 Jan 26;1(1):CD012144. doi: 10.1002/14651858.CD012144.pub3.
Mikami T, Hirabayashi K, Okawa K, Betsuyaku T, Watanabe S, Imamura Y, Tanizawa K, Hayashi T, Akao M, Yamashita T, Okumura K. Laboratory Test Predictors for Major Bleeding in Elderly (>/=80 Years) Patients With Nonvalvular Atrial Fibrillation Treated With Edoxaban 15 mg: Sub-Analysis of the ELDERCARE-AF Trial. J Am Heart Assoc. 2022 Sep 6;11(17):e024970. doi: 10.1161/JAHA.122.024970. Epub 2022 Sep 3.
Kuroda M, Tamiya E, Nose T, Ogimoto A, Taura J, Imamura Y, Fukuzawa M, Hayashi T, Akao M, Yamashita T, Lip GYH, Okumura K. Effect of 15-mg Edoxaban on Clinical Outcomes in 3 Age Strata in Older Patients With Atrial Fibrillation: A Prespecified Subanalysis of the ELDERCARE-AF Randomized Clinical Trial. JAMA Cardiol. 2022 Jun 1;7(6):583-590. doi: 10.1001/jamacardio.2022.0480.
Yoshida T, Nakamura A, Funada J, Amino M, Shimizu W, Fukuzawa M, Watanabe S, Hayashi T, Yamashita T, Okumura K, Akao M. Efficacy and Safety of Edoxaban 15 mg According to Renal Function in Very Elderly Patients With Atrial Fibrillation: A Subanalysis of the ELDERCARE-AF Trial. Circulation. 2022 Mar;145(9):718-720. doi: 10.1161/CIRCULATIONAHA.121.057190. Epub 2022 Feb 28. No abstract available.
Okumura K, Akao M, Yoshida T, Kawata M, Okazaki O, Akashi S, Eshima K, Tanizawa K, Fukuzawa M, Hayashi T, Akishita M, Lip GYH, Yamashita T; ELDERCARE-AF Committees and Investigators. Low-Dose Edoxaban in Very Elderly Patients with Atrial Fibrillation. N Engl J Med. 2020 Oct 29;383(18):1735-1745. doi: 10.1056/NEJMoa2012883. Epub 2020 Aug 30.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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163266
Identifier Type: REGISTRY
Identifier Source: secondary_id
DU176b-C-J316
Identifier Type: -
Identifier Source: org_study_id