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
2 other identifiers
interventional
984
1 country
164
Brief Summary
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.
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 Aug 2016
Typical duration for phase_3 atrial-fibrillation
164 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
First Submitted
Initial submission to the registry
June 13, 2016
CompletedFirst Posted
Study publicly available on registry
June 16, 2016
CompletedStudy Start
First participant enrolled
August 5, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 27, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 27, 2019
CompletedResults Posted
Study results publicly available
November 19, 2020
CompletedNovember 19, 2020
November 1, 2020
3.4 years
June 13, 2016
October 26, 2020
November 17, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (9)
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
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
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
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
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
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)
- +4 more secondary outcomes
Study Arms (2)
DU-176b 15 mg group
EXPERIMENTALDU-176b orally administered at a dose of 15 mg once daily.
Placebo group
PLACEBO COMPARATORPlacebo orally administered once daily.
Interventions
Eligibility Criteria
You may qualify if:
- Patients with Nonvalvular Atrial Fibrillation (NVAF) aged 80 years or older who are ineligible for available oral anticoagulation therapy
You may not qualify if:
- Patients with active bleeding
- Patients who have poorly controlled hypertension
- Patients who have liver dysfunction accompanied with disorder of blood coagulation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (164)
Social Corporation Keigakukai Minamiosaka Hospital
Osaka, Osaka, 559-0012, Japan
Hakujikai Memorial Hospital
Adachi-ku, 123-0864, Japan
Ageo Central General Hospital
Ageo, 362-8588, Japan
Medical Corporation Aijinkai Akashi Medical Center
Akashi, 674-0063, Japan
Ako City Hospital
Akō, 678-0232, Japan
Amagasaki New Town Hospital
Amagasaki, 661-0976, Japan
Anjo Kosei Hospital
Anjo, 446-8602, Japan
Shin-Ai Kai Honda Hospital
Annaka, 379-0124, Japan
Toyooka Chuo Hospital
Asahikawa, 078-8237, Japan
Tokyo Medical and Dental University Medical Hospital
Bunkyō City, 113-8519, Japan
Nippon Medical School Hospital
Bunkyō City, 113-8603, Japan
Fukuokaken Saiseikai Futsukaichi Hospital
Chikushino-shi, 818-8516, Japan
Aichi Koseiren Chita Kosei Hospital
Chita, 470-2404, Japan
Kashinoki Internal Medicine Clinic
Date, 960-0418, Japan
Medical Plaza Edogawa
Edagawa, 133-0052, Japan
Fukui General Clinic
Fukui, 910-0067, Japan
National Hospital Organization Kyushu Medical Center
Fukuoka, 810-0065, Japan
Onga Nakama Medical Association Onga Hospital
Fukuoka, 811-4342, Japan
Fukushima Daiichi Hospital
Fukushima, 960-8251, Japan
Funabashi Municipal Medical Center
Funabashi, 273-8588, Japan
Gifu Heart Center
Gifu, 500-8384, Japan
Minamino Cardiovascular Hospital
Hachiōji, 192-0918, Japan
Tokyo Tenshi Hospital
Hachiōji, 193-0811, Japan
Social welfare corporation Hakodate koseiin Hakodate Goryoukaku Hospital
Hakodate, 040-8585, Japan
National Hospital Organization Hakodate Hospital
Hakodate, 041-8512, Japan
National Hospital Organization Hamada Medical Center
Hamada, 697-8511, Japan
Hamamatsu Medical Center
Hamamatsu, 432-8580, Japan
Okitama Public General Hospital
Higashinakama, 992-0601, Japan
Social Medical Corporation, the Yamatokai Foundation Central Clinic affiliated clinic of Higashiyamato Hospital
Higashiyamato, 207-0014, Japan
Hikone Municipal Hospital
Hikone, 522-8539, Japan
Kanazawa Medical University Himi Municipal Hospital
Himi, 935-8531, Japan
Hiratsuka kyosai Hospital
Hiratsuka, 254-8502, Japan
Hirosaki Stroke and Rehabilitation Center
Hirosaki, 036-8104, Japan
Local Independent Administrative Corporation Hiroshima City Hospital Organization Hiroshima City Hiroshima Citizens Hospital
Hiroshima, 730-8518, Japan
National Hospital Organization Mito Medical Center
Ibaraki, 311-3193, Japan
Nippon Medical School Chiba Hokusoh Hospital
Inzai, 270-1694, Japan
Tokai University Hospital
Isehara, 259-1193, Japan
Kubo Clinic
Isesaki, 372-0841, Japan
Shimane University Hospital
Izumo, 693-8501, Japan
National Hospital Organization Kagoshima Medical Center
Kagoshima, 892-0853, Japan
National Hospital Organization Kanazawa Medical Center
Kanazawa, 920-8650, Japan
Kasugai Municipal Hospital
Kasugai, 486-8510, Japan
Asano Kanamachi Clinic
Katsushikachō, 125-0041, Japan
Saiseikai Kawaguchi General Hospital
Kawaguchi, 332-8558, Japan
St. Marianna University School of Medicine Hospital
Kawasaki, 216-8511, Japan
Kitasato University Medical Center
Kitamoto, 364-8501, Japan
Kobe Rosai Hospital
Kobe, 651-0053, Japan
Nose Hospital
Kobe, 653-0042, Japan
Medical Corporation Sakurakai Takahashi Hospital
Kobe, 654-0026, Japan
Nakayama Clinic of Internal Medicine and Cardiology
Kochi, 781-5106, Japan
Yamanashi Prefectural Central Hospital
Kofu, 400-8506, Japan
Kanno Reism Heart Clinic
Kosugi-shiraishi, 989-0218, Japan
Southern Tohoku Research Institute for Neuroscience, Southern Tohoku Medical Clinic
Kōriyama, 963-8052, Japan
Hoshi General Hospital
Kōriyama, 963-8501, Japan
Showa University Koto Toyosu Hospital
Kōtoku, 135-8577, Japan
Koto Hospital
Kōtoku, 136-0072, Japan
Saiseikai Kumamoto Hospital
Kumamoto, 861-4193, Japan
Kure Kyosai Hospital
Kure, 737-8505, Japan
Tanushimaru Central Hospital
Kurume, 839-1213, Japan
Kusatsu General Hospital
Kusatsu, 525-8585, Japan
Japanese Red Cross Kyoto Daini Hospital
Kyoto, 602-8026, Japan
National Hospital Organization Kyoto Medical Center
Kyoto, 612-8555, Japan
Machida Municipal Hospital
Machida, 194-0023, Japan
National Hospital Organization Maizuru Medical Center
Maizuru, 625-8502, Japan
New Tokyo Heart Clinic
Matsudo, 271-0077, Japan
Matsue City Hospital
Matsue, 690-8509, Japan
National Hospital Organization Matsumoto Medical Center
Matsumoto, 399-8701, Japan
Matsuyama Red Cross Hospital
Matsuyama, 790-8524, Japan
National Hospital Organization Tokyo Medical Center
Meguro-ku, 152-8902, Japan
Miyazaki Medical Association Hospital
Miyazaki, 880-0834, Japan
University of Miyazaki Hospital
Miyazaki, 889-1692, Japan
Iwate Prefectural Central Hospital
Morioka, 020-0066, Japan
Nagasaki Harbor Medical Center
Nagasaki, 850-8555, Japan
Nagoya Ekisaikai Hospital
Nagoya, 454-8502, Japan
Japanese Red Cross Nagoya Daini Hospital
Nagoya, 466-8650, Japan
Ohama Daiichi Hospital
Naha, 900-0005, Japan
Naha City Hospital
Naha, 902-8511, Japan
Takanohara Central Hospital
Nara, 631-0805, Japan
JCHO Nihonmatsu Hospital
Nihonmatsu, 964-0871, Japan
Meiwa Hospital
Nishinomiya, 663-8186, Japan
Ohyama Memorial Hospital
Nishiwaki, 679-0321, Japan
Ogawa Cardiovascular Internal Medicine Clinic
Obihiro, 080-0871, Japan
Shimada Hospital
Ogōri-shimogō, 838-0141, Japan
Sakurabashi Watanabe Hospital
Osaka, 530-0001, Japan
Osaka City Juso Hospital
Osaka, 532-0034, Japan
Kitada Clinic
Osaka, 538-0044, Japan
Osaka Police Hospital
Osaka, 543-0035, Japan
Osaka General Medical Center
Osaka, 558-8558, Japan
National Hospital Organization Osaka Minami Medical Center
Osaka, 586-0008, Japan
Sato Hospital
Osaka, 989-6143, Japan
Otaru Kyokai Hospital
Otaru, 047-8510, Japan
Ogaki Municipal Hospital
Ōgaki, 503-8502, Japan
Oita Prefectural Hospital
Ōita, 870-8511, Japan
Kouhoukai Takagi Hospital
Ōkawa, 831-0016, Japan
Ome Municipal General Hospital
Ōme, 198-0042, Japan
Omihachiman Community Medical Center
Ōmihachiman, 523-0082, Japan
National Hospital Organization Nagasaki Medical Center
Ōmura, 856-8562, Japan
Omori Sanno Hospital
Ōta-ku, 143-0023, Japan
JCHO Shiga Hospital
Ōtsu, 520-0846, Japan
Saga-Ken Medical Centre Koseikan
Saga, 840-8571, Japan
Saitama City Hospital
Saitama, 336-8522, Japan
Saitama Memorial Hospital
Saitama, 337-0012, Japan
Saku Central Hospital Advanced Care Center
Saku, 385-0051, Japan
Kin-ikyo Chuo Hospital
Sapporo, 007-8505, Japan
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
Sapporo, 060-0033, Japan
National Hospital Organization Hokkaido Medical Center
Sapporo, 063-0005, Japan
Sapporo Nishimaruyama Hospital
Sapporo, 064-8557, Japan
Miyanomori Memorial Hospital
Sapporo, 064-8570, Japan
Hokkaido Cardiovascular Hospital
Sapporo, 064-8622, Japan
Shukokai Internal Medicine Sato Hospital
Sendai, 980-0011, Japan
KKR Tohoku Kosai Hospital
Sendai, 980-0803, Japan
National Hospital Organization Sendai Medical Center
Sendai, 983-8520, Japan
Tosei General Hospital
Seto, 489-8642, Japan
National Hospital Organization Kanmon Medical Center
Shimonoseki, 752-8510, Japan
Dokkyo Medical University Hospital
Shimosuga, 321-0293, Japan
Tokyo Heart Center
Shinagawa-Ku, 141-0001, Japan
Showa University Hospital
Shinagawa-Ku, 142-8666, Japan
Center Hospital of the National Center for Global Health and Medicine
Shinjuku-Ku, 162-8655, Japan
Shirakawa Hospital
Shirakawa, 961-0092, Japan
Iwate Medical University Hospital
Shiwa-gun, 020-8505, Japan
National Hospital Organization Shizuoka Medical Center
Shizuoka, 411-8611, Japan
Ikeda Kinen Hospital
Sukagawa, 962-0001, Japan
Iwase General Hospital
Sukagawa, 962-8503, Japan
Hyogo Prefectural Awaji Medical Center
Sumoto, 656-0021, Japan
Nagano Prefectural Shinshu Medical Hospital
Suzaka, 382-0000, Japan
National Hospital Organization Disaster Medical Center
Tachikawa, 190-0014, Japan
Social Insurance Tagawa Hospital
Tagawa, 826-8585, Japan
Kagawa Prefectural Central Hospital
Takamatsu, 760-8557, Japan
Kouseiren Takaoka Hospital
Takaoka, 933-8555, Japan
Medical Corporation Aishinkai Higashi Takarazuka Satoh Hospital
Takarazuka, 665-0873, Japan
Kan-etsu Chu-oh Hospital
Takasaki, 370-3513, Japan
Takatsuki General Hospital
Takatsuki, 569-1192, Japan
National Hospital Organization Minami Wakayama Medical Center
Tanabe, 646-8558, Japan
Tenri Hospital
Tenri, 632-8552, Japan
Kuwanomi Hongou Clinic
Tokorozawa, 359-0022, Japan
Saino Clinic
Tokorozawa, 359-1141, Japan
Tokorozawa Heart Center
Tokorozawa, 359-1142, Japan
Tokushima University Hospital
Tokushima, 770-8503, Japan
Tokushima Prefectural Central Hospital
Tokushima, 770-8539, Japan
Nerima General Hospital
Tokyo, 176-8530, Japan
Tomakomai City Hospital
Tomakomai, 053-8567, Japan
Public Tomioka General Hospital
Tomioka, 370-2393, Japan
Yamaguchi Clinic
Toshima-ku, 170-0001, Japan
Yayoigaoka Kage Hospital
Tosu, 841-0005, Japan
National Hospital Organization Toyohashi Medical Center
Toyohashi, 440-8510, Japan
TOYOTA Memorial Hospital
Toyota, 471-0821, Japan
National Hospital Organization Ehime Medical Center
Tōon, 791-0281, Japan
Tsukuba Memorial Hospital
Tsukuba, 300-2622, Japan
Okinawa Prefectural Chubu Hospital
Uruma, 904-2293, Japan
National Hospital Organization Tochigi Medical Center
Utsunomiya, 320-8580, Japan
Uwajima City Hospital
Uwajima, 798-8510, Japan
Wakayama Rosai Hospital
Wakayama, 640-8505, Japan
Nagata Hospital
Yanagawa, 832-0059, Japan
Kumamoto General Hospital
Yatsushiro, 866-8660, Japan
Yokohama Municipal Citizen's Hospital
Yokohama, 221-0855, Japan
Yokohama Rosai Hospital
Yokohama, 222-0036, Japan
Showa University Fujigaoka Hospital
Yokohama, 227-8501, Japan
JCHO Yokohama Chuo Hospital
Yokohama, 231-8553, Japan
Yokohama City Minato Red Cross Hospital
Yokohama, 231-8682, Japan
Yokohama City University Medical Center
Yokohama, 232-0024, Japan
Saiseikai Yokohamashi Nanbu Hospital
Yokohama, 234-8503, Japan
Yokohama Minami Kyousai Hospital
Yokohama, 236-0037, Japan
National Hospital Organization Yokohama Medical Center
Yokohama, 245-8575, Japan
Yokohama Sakae Kyosai Hospital
Yokohama, 247-8581, Japan
Related Publications (6)
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.
PMID: 38240204DERIVEDCochrane 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.
PMID: 36700520DERIVEDMikami 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.
PMID: 36056729DERIVEDKuroda 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.
PMID: 35416910DERIVEDYoshida 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.
PMID: 35226559DERIVEDOkumura 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.
PMID: 32865374DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Contact for Clinical Trial Information
- Organization
- Daiichi Sankyo
Study Officials
- STUDY DIRECTOR
Global Clinical Leader
Daiichi Sankyo
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
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 13, 2016
First Posted
June 16, 2016
Study Start
August 5, 2016
Primary Completion
December 27, 2019
Study Completion
December 27, 2019
Last Updated
November 19, 2020
Results First Posted
November 19, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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.
- 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.
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/