Study of DU-176b Aged 80 Years or Older

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study of DU-176b in Patients With NVAF Aged 80 Years or Older Who Are Ineligible for Available Oral Anticoagulation Therapy

The purpose of this study is to evaluate the efficacy and safety of edoxaban in patients with non-valvular NVAF aged 80 years or older who are ineligible for available oral anticoagulation therapy.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Drug: Du-176b; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 984
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Adachi-ku, Japan, 123-0864
    • Hakujikai Memorial Hospital
  • Ageo-city, Japan, 362-8588
    • Ageo Central General Hospital
  • Akashi-city, Japan, 674-0063
    • Medical Corporation Aijinkai Akashi Medical Center
  • Ako-city, Japan, 678-0232
    • Ako City Hospital
  • Amagasaki-city, Japan, 661-0976
    • Amagasaki New Town Hospital
  • Anjō-city, Japan, 446-8602
    • Anjo Kosei Hospital
  • Annaka-city, Japan, 379-0124
    • Shin-Ai Kai Honda Hospital
  • Asahikawa-city, Japan, 078-8237
    • Toyooka Chuo Hospital
  • Bunkyō-Ku, Japan, 113-8519
    • Tokyo Medical and Dental University Medical Hospital
  • Bunkyō-Ku, Japan, 113-8603
    • Nippon Medical School Hospital
  • Chikushino-city, Japan, 818-8516
    • Fukuokaken Saiseikai Futsukaichi Hospital
  • Chita, Japan, 470-2404
    • Aichi Koseiren Chita Kosei Hospital
  • Date-city, Japan, 960-0418
    • Kashinoki Internal Medicine Clinic
  • Edagawa, Japan, 133-0052
    • Medical Plaza Edogawa
  • Fukui-city, Japan, 910-0067
    • Fukui General Clinic
  • Fukuoka, Japan, 811-4342
    • Onga Nakama Medical Association Onga Hospital
  • Fukuoka-city, Japan, 810-0065
    • National Hospital Organization Kyushu Medical Center
  • Fukushima-city, Japan, 960-8251
    • Fukushima Daiichi Hospital
  • Funabashi-city, Japan, 273-8588
    • Funabashi Municipal Medical Center
  • Gifu-city, Japan, 500-8384
    • Gifu Heart Center
  • Hachiōji-city, Japan, 192-0918
    • Minamino Cardiovascular Hospital
  • Hachiōji-city, Japan, 193-0811
    • Tokyo Tenshi Hospital
  • Hakodate-city, Japan, 040-8585
    • Social welfare corporation Hakodate koseiin Hakodate Goryoukaku Hospital
  • Hakodate-city, Japan, 041-8512
    • National Hospital Organization Hakodate Hospital
  • Hamada-city, Japan, 697-8511
    • National Hospital Organization Hamada Medical Center
  • Hamamatsu-city, Japan, 432-8580
    • Hamamatsu Medical Center
  • Higashinakama, Japan, 992-0601
    • Okitama Public General Hospital
  • Higashiyamato, Japan, 207-0014
    • Social Medical Corporation, the Yamatokai Foundation Central Clinic affiliated clinic of Higashiyamato Hospital
  • Hikone, Japan, 522-8539
    • Hikone Municipal Hospital
  • Himi, Japan, 935-8531
    • Kanazawa Medical University Himi Municipal Hospital
  • Hiratsuka-city, Japan, 254-8502
    • Hiratsuka Kyosai Hospital
  • Hirosaki-city, Japan, 036-8104
    • Hirosaki Stroke and Rehabilitation Center
  • Hiroshima-city, Japan, 730-8518
    • Local Independent Administrative Corporation Hiroshima City Hospital Organization Hiroshima City Hiroshima Citizens Hospital
  • Ibaraki, Japan, 311-3193
    • National Hospital Organization Mito Medical Center
  • Inzai-city, Japan, 270-1694
    • Nippon Medical School Chiba Hokusoh Hospital
  • Isehara-city, Japan, 259-1193
    • Tokai University Hospital
  • Isesaki, Japan, 372-0841
    • Kubo Clinic
  • Izumo-city, Japan, 693-8501
    • Shimane University Hospital
  • Kagoshima-city, Japan, 892-0853
    • National Hospital Organization Kagoshima Medical Center
  • Kanazawa-city, Japan, 920-8650
    • National Hospital Organization Kanazawa Medical Center
  • Kasugai-city, Japan, 486-8510
    • Kasugai Municipal Hospital
  • Katsushikachō, Japan, 125-0041
    • Asano Kanamachi Clinic
  • Kawaguchi-city, Japan, 332-8558
    • Saiseikai Kawaguchi General Hospital
  • Kawasaki-city, Japan, 216-8511
    • St. Marianna University School of Medicine Hospital
  • Kitamoto-city, Japan, 364-8501
    • Kitasato University Medical Center
  • Kobe city, Japan, 651-0053
    • Kobe Rosai Hospital
  • Kobe-city, Japan, 653-0042
    • Nose Hospital
  • Kobe-city, Japan, 654-0026
    • Medical Corporation Sakurakai Takahashi Hospital
  • Kochi-city, Japan, 781-5106
    • Nakayama Clinic of Internal Medicine and Cardiology
  • Kofu-city, Japan, 400-8506
    • Yamanashi Prefectural Central Hospital
  • Kosugi-shiraishi, Japan, 989-0218
    • Kanno Reism Heart Clinic
  • Koto-Ku, Japan, 135-8577
    • Showa University Koto Toyosu Hospital
  • Koto-Ku, Japan, 136-0072
    • Koto Hospital
  • Kumamoto-city, Japan, 861-4193
    • Saiseikai Kumamoto Hospital
  • Kure-city, Japan, 737-8505
    • Kure Kyosai Hospital
  • Kurume-city, Japan, 839-1213
    • Tanushimaru Central Hospital
  • Kusatsu-city, Japan, 525-8585
    • Kusatsu General Hospital
  • Kyoto-city, Japan, 602-8026
    • Japanese Red Cross Kyoto Daini Hospital
  • Kyoto-city, Japan, 612-8555
    • National Hospital Organization Kyoto Medical Center
  • Kōriyama-city, Japan, 963-8052
    • Southern Tohoku Research Institute for Neuroscience, Southern Tohoku Medical Clinic
  • Kōriyama-city, Japan, 963-8501
    • Hoshi General Hospital
  • Machida-city, Japan, 194-0023
    • Machida Municipal Hospital
  • Maizuru-city, Japan, 625-8502
    • National Hospital Organization Maizuru Medical Center
  • Matsudo-city, Japan, 271-0077
    • New Tokyo Heart Clinic
  • Matsue-city, Japan, 690-8509
    • Matsue City Hospital
  • Matsumoto-city, Japan, 399-8701
    • National Hospital Organization Matsumoto Medical Center
  • Matsuyama-city, Japan, 790-8524
    • Matsuyama Red Cross Hospital
  • Meguro-ku, Japan, 152-8902
    • National Hospital Organization Tokyo Medical Center
  • Miyazaki-city, Japan, 880-0834
    • Miyazaki Medical Association Hospital
  • Miyazaki-city, Japan, 889-1692
    • University of Miyazaki Hospital
  • Morioka-city, Japan, 020-0066
    • Iwate Prefectural Central Hospital
  • Nagasaki-city, Japan, 850-8555
    • Nagasaki Harbor Medical Center
  • Nagoya-city, Japan, 454-8502
    • Nagoya Ekisaikai Hospital
  • Nagoya-city, Japan, 466-8650
    • Japanese Red Cross Nagoya Daini Hospital
  • Naha-city, Japan, 900-0005
    • Ohama Daiichi Hospital
  • Naha-city, Japan, 902-8511
    • Naha City Hospital
  • Nara-city, Japan, 631-0805
    • Takanohara Central Hospital
  • Nihonmatsu, Japan, 964-0871
    • JCHO Nihonmatsu Hospital
  • Nishinomiya-city, Japan, 663-8186
    • Meiwa Hospital
  • Nishiwaki-city, Japan, 679-0321
    • Ohyama Memorial Hospital
  • Obihiro-city, Japan, 080-0871
    • Ogawa Cardiovascular Internal Medicine Clinic
  • Ogaki-city, Japan, 503-8502
    • Ogaki Municipal Hospital
  • Ogōri-shimogō, Japan, 838-0141
    • Shimada Hospital
  • Ome-city, Japan, 198-0042
    • Ome Municipal General Hospital
  • Omura-city, Japan, 856-8562
    • National Hospital Organization Nagasaki Medical Center
  • Osaka, Japan, 586-0008
    • National Hospital Organization Osaka Minami Medical Center
  • Osaka-city, Japan, 530-0001
    • Sakurabashi Watanabe Hospital
  • Osaka-city, Japan, 532-0034
    • Osaka City Juso Hospital
  • Osaka-city, Japan, 538-0044
    • Kitada Clinic
  • Osaka-city, Japan, 543-0035
    • Osaka Police Hospital
  • Osaka-city, Japan, 558-8558
    • Osaka General Medical Center
  • Osaka-city, Japan, 989-6143
    • Sato Hospital
  • Otaru-city, Japan, 047-8510
    • Otaru Kyokai Hospital
  • Saga-city, Japan, 840-8571
    • Saga-ken Medical Centre Koseikan
  • Saitama-city, Japan, 336-8522
    • Saitama City Hospital
  • Saitama-city, Japan, 337-0012
    • Saitama Memorial Hospital
  • Saku-city, Japan, 385-0051
    • Saku Central Hospital Advanced Care Center
  • Sapporo-city, Japan, 007-8505
    • Kin-ikyo Chuo Hospital
  • Sapporo-city, Japan, 060-0033
    • Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
  • Sapporo-city, Japan, 063-0005
    • National Hospital Organization Hokkaido Medical Center
  • Sapporo-city, Japan, 064-8557
    • Sapporo Nishimaruyama Hospital
  • Sapporo-city, Japan, 064-8570
    • Miyanomori Memorial Hospital
  • Sapporo-city, Japan, 064-8622
    • Hokkaido Cardiovascular Hospital
  • Sendai-city, Japan, 980-0011
    • Shukokai Internal Medicine Sato Hospital
  • Sendai-city, Japan, 980-0803
    • KKR Tohoku Kosai Hospital
  • Sendai-city, Japan, 983-8520
    • National Hospital Organization Sendai Medical Center
  • Seto-city, Japan, 489-8642
    • Tosei General Hospital
  • Shimonoseki-city, Japan, 752-8510
    • National Hospital Organization Kanmon Medical Center
  • Shimosuga, Japan, 321-0293
    • Dokkyo Medical University Hospital
  • Shinagawa-Ku, Japan, 141-0001
    • Tokyo Heart Center
  • Shinagawa-Ku, Japan, 142-8666
    • Showa University Hospital
  • Shinjuku-Ku, Japan, 162-8655
    • Center Hospital of the National Center for Global Health and Medicine
  • Shirakawa-city, Japan, 961-0092
    • Shirakawa Hospital
  • Shiwa-gun, Japan, 020-8505
    • Iwate Medical University Hospital
  • Shizuoka, Japan, 411-8611
    • National Hospital Organization Shizuoka Medical Center
  • Sukagawa-city, Japan, 962-0001
    • Ikeda Kinen Hospital
  • Sukagawa-city, Japan, 962-8503
    • Iwase General Hospital
  • Sumoto-city, Japan, 656-0021
    • Hyogo Prefectural Awaji Medical Center
  • Suzaka-city, Japan, 382-0000
    • Nagano Prefectural Shinshu Medical Hospital
  • Tachikawa-city, Japan, 190-0014
    • National Hospital Organization Disaster Medical Center
  • Tagawa, Japan, 826-8585
    • Social Insurance Tagawa Hospital
  • Takamatsu-city, Japan, 760-8557
    • Kagawa Prefectural Central Hospital
  • Takaoka-city, Japan, 933-8555
    • Kouseiren Takaoka Hospital
  • Takarazuka-city, Japan, 665-0873
    • Medical Corporation Aishinkai Higashi Takarazuka Satoh Hospital
  • Takasaki-city, Japan, 370-3513
    • Kan-etsu chu-oh Hospital
  • Takatsuki-city, Japan, 569-1192
    • Takatsuki General Hospital
  • Tanabe-city, Japan, 646-8558
    • National Hospital Organization Minami Wakayama Medical Center
  • Tenri-city, Japan, 632-8552
    • Tenri Hospital
  • Tokorozawa-city, Japan, 359-0022
    • Kuwanomi Hongou Clinic
  • Tokorozawa-city, Japan, 359-1141
    • Saino Clinic
  • Tokorozawa-city, Japan, 359-1142
    • Tokorozawa Heart Center
  • Tokushima-city, Japan, 770-8503
    • Tokushima University Hospital
  • Tokushima-city, Japan, 770-8539
    • Tokushima Prefectural Central Hospital
  • Tokyo, Japan, 176-8530
    • Nerima General Hospital
  • Tomakomai-city, Japan, 053-8567
    • Tomakomai City Hospital
  • Tomioka-city, Japan, 370-2393
    • Public Tomioka General Hospital
  • Toon-city, Japan, 791-0281
    • National Hospital Organization Ehime Medical Center
  • Toshima-ku, Japan, 170-0001
    • Yamaguchi Clinic
  • Tosu, Japan, 841-0005
    • Yayoigaoka Kage Hospital
  • Toyohashi-city, Japan, 440-8510
    • National Hospital Organization Toyohashi Medical Center
  • Toyota-city, Japan, 471-0821
    • Toyota Memorial Hospital
  • Tsukuba-city, Japan, 300-2622
    • Tsukuba Memorial Hospital
  • Uruma-city, Japan, 904-2293
    • Okinawa Prefectural Chubu Hospital
  • Utsunomiya-city, Japan, 320-8580
    • National Hospital Organization Tochigi Medical Center
  • Uwajima, Japan, 798-8510
    • Uwajima City Hospital
  • Wakayama-city, Japan, 640-8505
    • Wakayama Rosai Hospital
  • Yanagawa-city, Japan, 832-0059
    • Nagata Hospital
  • Yatsushiro-city, Japan, 866-8660
    • Kumamoto General Hospital
  • Yokohama-city, Japan, 221-0855
    • Yokohama Municipal Citizen's Hospital
  • Yokohama-city, Japan, 222-0036
    • Yokohama Rosai Hospital
  • Yokohama-city, Japan, 227-8501
    • Showa University Fujigaoka Hospital
  • Yokohama-city, Japan, 231-8553
    • JCHO Yokohama Chuo Hospital
  • Yokohama-city, Japan, 231-8682
    • Yokohama City Minato Red Cross Hospital
  • Yokohama-city, Japan, 232-0024
    • Yokohama City University Medical Center
  • Yokohama-city, Japan, 234-8503
    • Saiseikai Yokohamashi Nanbu Hospital
  • Yokohama-city, Japan, 236-0037
    • Yokohama Minami Kyousai Hospital
  • Yokohama-city, Japan, 245-8575
    • National Hospital Organization Yokohama Medical Center
  • Yokohama-city, Japan, 247-8581
    • Yokohama Sakae Kyosai Hospital
  • Ōita-city, Japan, 870-8511
    • Oita Prefectural Hospital
  • Ōkawa, Japan, 831-0016
    • Kouhoukai Takagi Hospital
  • Ōmihachiman-city, Japan, 523-0082
    • Omihachiman Community Medical Center
  • Ōta-ku, Japan, 143-0023
    • Omori Sanno Hospital
  • Ōtsu-city, Japan, 520-0846
    • JCHO Shiga Hospital
  • Osaka
    • Osaka-city, Osaka, Japan, 559-0012
      • Social Corporation Keigakukai Minamiosaka Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 80 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with Nonvalvular Atrial Fibrillation (NVAF) aged 80 years or older who are ineligible for available oral anticoagulation therapy

Exclusion Criteria:

• Patients with active bleeding
• Patients who have poorly controlled hypertension
• Patients who have liver dysfunction accompanied with disorder of blood coagulation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DU-176b 15 mg group; DU-176b orally administered at a dose of 15 mg once daily.	Drug: Du-176b; DU-176b orally administered at a dose of 15 mg once daily.; Other Names: edoxaban
Placebo Comparator: Placebo group; Placebo orally administered once daily.	Drug: placebo; Placebo orally administered once daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With a Composite Endpoint of Stroke and Systemic Embolic Events (SEE) in Participants Who Were Administered DU-176b Compared With Placebo	Stroke was defined as an abrupt onset, over minutes to hours, of symptoms representing focal neurological deficit in the domain supplied by a single brain artery (including the retinal artery) and that was not due to an identifiable non-vascular cause (such as brain tumor or trauma). The deficit symptoms had to either last for more than 24 hours or result in death within 24 hours of symptom onset. A systemic embolic event (SEE) was defined as an abrupt episode of arterial insufficiency associated with clinical or radiologic evidence of arterial occlusion in the absence of other likely mechanisms (eg, atherosclerosis and instrumentation).	Randomization up to the time of onset of the initial composite event of stroke or systemic embolic event, or study discontinuation, or end of study (whichever comes first), up to 3 years 2 months postdose (maximum follow-up time)
Number of Participants With Stroke and Systemic Embolic Events (SEE), Including Subcomponents of Stroke and Composite Event of Ischemic Stroke and SEE in Participants Who Were Administered DU-176b Compared With Placebo	Stroke was defined as an abrupt onset, over minutes to hours, of symptoms representing focal neurological deficit in the domain supplied by a single brain artery (including the retinal artery) and that was not due to an identifiable non-vascular cause (such as brain tumor or trauma). The deficit symptoms had to either last for more than 24 hours or result in death within 24 hours of symptom onset. Subcomponents of stroke (ischemic and hemorrhagic) were also reported. A systemic embolic event (SEE) was defined as an abrupt episode of arterial insufficiency associated with clinical or radiologic evidence of arterial occlusion in the absence of other likely mechanisms (eg, atherosclerosis and instrumentation).	Randomization up to the time of onset of the initial composite event of stroke or systemic embolic event, or study discontinuation, or end of study (whichever comes first), up to 3 years 2 months postdose (maximum follow-up time)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With a Composite Endpoint of Stroke, Systemic Embolic Events (SEE), and Death Due to Cardiovascular in Participants Who Were Administered DU-176b Compared With Placebo	Stroke was defined as an abrupt onset, over minutes to hours, of symptoms representing focal neurological deficit in the domain supplied by a single brain artery (including the retinal artery) and that was not due to an identifiable non-vascular cause (such as brain tumor or trauma). The deficit symptoms had to either last for more than 24 hours or result in death within 24 hours of symptom onset. A systemic embolic event (SEE) was defined as an abrupt episode of arterial insufficiency associated with clinical or radiologic evidence of arterial occlusion in the absence of other likely mechanisms (eg, atherosclerosis and instrumentation).	Randomization up to the time of onset of the initial composite event of stroke, systemic embolic event, or death due to CV, or study discontinuation, or end of study (whichever comes first), up to 3 years 2 months postdose (maximum follow-up time)
Number of Participants With a Composite Endpoint of a Major Adverse Cardiovascular Event (MACE) in Participants Who Were Administered DU-176b Compared With Placebo	Major adverse cardiovascular events (MACE) included a composite of non-fatal myocardial infarction (MI), non-fatal stroke, non-fatal systemic embolic events (SEE), and deaths due to cardiovascular (CV) or bleeding. Stroke was defined as an abrupt onset, over minutes to hours, of symptoms representing focal neurological deficit in the domain supplied by a single brain artery (including the retinal artery) and that was not due to an identifiable non-vascular cause (such as brain tumor or trauma). The deficit symptoms had to either last for more than 24 hours or result in death within 24 hours of symptom onset. A SEE was defined as an abrupt episode of arterial insufficiency associated with clinical or radiologic evidence of arterial occlusion in the absence of other likely mechanisms (eg, atherosclerosis and instrumentation).	Randomization up to the time of onset of the initial MACE event, or study discontinuation, or end of study (whichever comes first), up to 3 years 2 months postdose (maximum follow-up time)
Number of Participants With a Composite Endpoint of Stroke, Systemic Embolic Events (SEE), and All-Cause Mortality in Participants Who Were Administered DU-176b Compared With Placebo	Stroke was defined as an abrupt onset, over minutes to hours, of symptoms representing focal neurological deficit in the domain supplied by a single brain artery (including the retinal artery) and that was not due to an identifiable non-vascular cause (such as brain tumor or trauma). The deficit symptoms had to either last for more than 24 hours or result in death within 24 hours of symptom onset. A systemic embolic event (SEE) was defined as an abrupt episode of arterial insufficiency associated with clinical or radiologic evidence of arterial occlusion in the absence of other likely mechanisms (eg, atherosclerosis and instrumentation). All-cause mortality was defined as death due to cardiovascular and mortality due to all other causes.	Randomization up to the time of onset of the initial composite event of stroke, SEE, all-cause mortality, or study discontinuation, or end of study (whichever comes first), up to 3 years 2 months postdose (maximum follow-up time)
Number of Participants With Net Clinical Benefit in Participants Who Were Administered DU-176b Compared With Placebo	Net clinical benefit included a composite of stroke, systemic embolic events (SEE), major bleeding, and all-cause mortality. Stroke was defined as an abrupt onset of symptoms representing focal neurological deficit in the domain supplied by a single brain artery that was not due to an identifiable non-vascular cause. The deficit symptoms had to either last >24 hours or result in death within 24 hours of symptom onset. A SEE was defined as an abrupt episode of arterial insufficiency associated with clinical or radiologic evidence of arterial occlusion in the absence of other likely mechanisms. Major bleeding was defined as overt bleeding that met at least 1 of the following criteria: fatal bleeding; retroperitoneal, intracranial, intraocular, intrathecal, intraarticular, or pericardial bleeding, or symptomatic intramuscular bleeding accompanied by compartment syndrome; or clinically overt bleeding that decreased hemoglobin by at least 2.0 g/dL and required blood transfusion.	Randomization up to the time of onset of the initial composite event of stroke, SEE, major bleeding, all-cause mortality, or study discontinuation, or end of study (whichever comes first), up to 3 years 2 months postdose (maximum follow-up time)
Number of Participants With All-Cause Mortality in Participants Who Were Administered DU-176b Compared With Placebo	All-cause mortality was defined as death due to cardiovascular and mortality due to all other causes.	Randomization up to death (due to any cause), or study discontinuation, or end of study (whichever comes first), up to 3 years 2 months postdose (maximum follow-up time)
Number of Participants With Major Bleeding During On-Treatment Period in Participants Who Were Administered DU-176b Compared With Placebo	Major bleeding was defined as overt bleeding that met at least 1 of the following criteria: fatal bleeding; retroperitoneal, intracranial, intraocular, intrathecal, intraarticular, or pericardial bleeding, or symptomatic intramuscular bleeding accompanied by compartment syndrome; or clinically overt bleeding that decreased hemoglobin by at least 2.0 g/dL and required blood transfusion.	Baseline up to study discontinuation or end of study (whichever comes first), up to 3 years 2 months postdose (maximum follow-up time)
Number of Participants With Major Bleeding or Clinically Relevant Non-major Bleedings During On-Treatment Period in Participants Who Were Administered DU-176b Compared With Placebo	Major bleeding was defined as overt bleeding that met at least 1 of the following criteria: fatal bleeding; retroperitoneal, intracranial, intraocular, intrathecal, intraarticular, or pericardial bleeding, or symptomatic intramuscular bleeding accompanied by compartment syndrome; or clinically overt bleeding that decreased hemoglobin by at least 2.0 g/dL and required blood transfusion. Clinically overt bleeding that required treatment was taken to be clinically relevant non-major bleeding, including for example (but was not limited to) the bleeding that led to the diagnostic tests and treatments as specified in the protocol. The clinically overt bleeding requiring treatment did not include outpatient examinations that did not involve any of the medical procedures (diagnostic tests or treatments) as specified in the protocol.	Baseline up to study discontinuation or end of study (whichever comes first), up to 3 years 2 months postdose (maximum follow-up time)
Number of Participants With All Bleeding Events and Minor Bleeding Events During On-Treatment Period in Participants Who Were Administered DU-176b Compared With Placebo	All bleeding events include major and clinically relevant non-major bleeding events. Other overt bleeding events that did not meet the criteria for major bleeding or clinically relevant non-major bleeding were taken to be minor bleeding (for example, epistaxis that did not require treatment). All events other than the above (such as a decrease in hemoglobin without overt bleeding) were classified as "non-bleeding event."	Baseline up to study discontinuation or end of study (whichever comes first), up to 3 years 2 months postdose (maximum follow-up time)
Plasma Concentration of DU-176 in Participants Who Were Administered DU-176b		Week 8: Predose,1-3 hours (h) and 4-8 h postdose

Collaborators and Investigators

• Sponsor: Daiichi Sankyo Co., Ltd.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2016
• Primary Completion (Actual): December 27, 2019
• Study Completion (Actual): December 27, 2019

Study Registration Dates

• First Submitted: June 13, 2016
• First Submitted That Met QC Criteria: June 15, 2016
• First Posted (Estimate): June 16, 2016

Study Record Updates

• Last Update Posted (Actual): November 19, 2020
• Last Update Submitted That Met QC Criteria: November 17, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: atrial fibrillation; prevention; anticoagulants; oral; factor Xa; edoxaban; DU-176b
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Edoxaban
• Other Study ID Numbers: DU176b-C-J316; 163266 (Registry Identifier: JAPIC CTI)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
• IPD Sharing Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
• IPD Sharing Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR