Atrial FibrillationPhase 3NCT02801669
Study of DU-176b Aged 80 Years or Older
A Phase 3 study testing Du-176b in people with Atrial Fibrillation, run by Daiichi Sankyo Co., Ltd. at 164 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 80 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Du-176b
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 984 participants
- Where
- 164 sitesJapan
- Study dates
- 5 Aug 2016to 27 Dec 2019
- 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 80 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients with Nonvalvular Atrial Fibrillation (NVAF) aged 80 years or older who are ineligible for available oral anticoagulation therapy
Who cannot join
- Patients with active bleeding
- Patients who have poorly controlled hypertension
- Patients who have liver dysfunction accompanied with disorder of blood coagulation
Trial locations and contacts
164 sites in 1 country.
164 sites in 1 country
Japan164 sites
Hakujikai Memorial Hospital
Adachi-ku, 123-0864
Ageo Central General Hospital
Ageo, 362-8588
Medical Corporation Aijinkai Akashi Medical Center
Akashi, 674-0063
Ako City Hospital
Akō, 678-0232
Amagasaki New Town Hospital
Amagasaki, 661-0976
Anjo Kosei Hospital
Anjo, 446-8602
Shin-Ai Kai Honda Hospital
Annaka, 379-0124
Toyooka Chuo Hospital
Asahikawa, 078-8237
Tokyo Medical and Dental University Medical Hospital
Bunkyō City, 113-8519
Nippon Medical School Hospital
Bunkyō City, 113-8603
Fukuokaken Saiseikai Futsukaichi Hospital
Chikushino-shi, 818-8516
Aichi Koseiren Chita Kosei Hospital
Chita, 470-2404
Kashinoki Internal Medicine Clinic
Date, 960-0418
Medical Plaza Edogawa
Edagawa, 133-0052
Fukui General Clinic
Fukui, 910-0067
National Hospital Organization Kyushu Medical Center
Fukuoka, 810-0065
Onga Nakama Medical Association Onga Hospital
Fukuoka, 811-4342
Fukushima Daiichi Hospital
Fukushima, 960-8251
Funabashi Municipal Medical Center
Funabashi, 273-8588
Gifu Heart Center
Gifu, 500-8384
Minamino Cardiovascular Hospital
Hachiōji, 192-0918
Tokyo Tenshi Hospital
Hachiōji, 193-0811
Social welfare corporation Hakodate koseiin Hakodate Goryoukaku Hospital
Hakodate, 040-8585
National Hospital Organization Hakodate Hospital
Hakodate, 041-8512
National Hospital Organization Hamada Medical Center
Hamada, 697-8511
Hamamatsu Medical Center
Hamamatsu, 432-8580
Okitama Public General Hospital
Higashinakama, 992-0601
Social Medical Corporation, the Yamatokai Foundation Central Clinic affiliated clinic of Higashiyamato Hospital
Higashiyamato, 207-0014
Hikone Municipal Hospital
Hikone, 522-8539
Kanazawa Medical University Himi Municipal Hospital
Himi, 935-8531
Hiratsuka kyosai Hospital
Hiratsuka, 254-8502
Hirosaki Stroke and Rehabilitation Center
Hirosaki, 036-8104
Local Independent Administrative Corporation Hiroshima City Hospital Organization Hiroshima City Hiroshima Citizens Hospital
Hiroshima, 730-8518
National Hospital Organization Mito Medical Center
Ibaraki, 311-3193
Nippon Medical School Chiba Hokusoh Hospital
Inzai, 270-1694
Tokai University Hospital
Isehara, 259-1193
Kubo Clinic
Isesaki, 372-0841
Shimane University Hospital
Izumo, 693-8501
National Hospital Organization Kagoshima Medical Center
Kagoshima, 892-0853
National Hospital Organization Kanazawa Medical Center
Kanazawa, 920-8650
Kasugai Municipal Hospital
Kasugai, 486-8510
Asano Kanamachi Clinic
Katsushikachō, 125-0041
Saiseikai Kawaguchi General Hospital
Kawaguchi, 332-8558
St. Marianna University School of Medicine Hospital
Kawasaki, 216-8511
Kitasato University Medical Center
Kitamoto, 364-8501
Kobe Rosai Hospital
Kobe, 651-0053
Nose Hospital
Kobe, 653-0042
Medical Corporation Sakurakai Takahashi Hospital
Kobe, 654-0026
Nakayama Clinic of Internal Medicine and Cardiology
Kochi, 781-5106
Yamanashi Prefectural Central Hospital
Kofu, 400-8506
Southern Tohoku Research Institute for Neuroscience, Southern Tohoku Medical Clinic
Kōriyama, 963-8052
Hoshi General Hospital
Kōriyama, 963-8501
Kanno Reism Heart Clinic
Kosugi-shiraishi, 989-0218
Showa University Koto Toyosu Hospital
Kōtoku, 135-8577
Koto Hospital
Kōtoku, 136-0072
Saiseikai Kumamoto Hospital
Kumamoto, 861-4193
Kure Kyosai Hospital
Kure, 737-8505
Tanushimaru Central Hospital
Kurume, 839-1213
Kusatsu General Hospital
Kusatsu, 525-8585
Japanese Red Cross Kyoto Daini Hospital
Kyoto, 602-8026
National Hospital Organization Kyoto Medical Center
Kyoto, 612-8555
Machida Municipal Hospital
Machida, 194-0023
National Hospital Organization Maizuru Medical Center
Maizuru, 625-8502
New Tokyo Heart Clinic
Matsudo, 271-0077
Matsue City Hospital
Matsue, 690-8509
National Hospital Organization Matsumoto Medical Center
Matsumoto, 399-8701
Matsuyama Red Cross Hospital
Matsuyama, 790-8524
National Hospital Organization Tokyo Medical Center
Meguro-ku, 152-8902
Miyazaki Medical Association Hospital
Miyazaki, 880-0834
University of Miyazaki Hospital
Miyazaki, 889-1692
Iwate Prefectural Central Hospital
Morioka, 020-0066
Nagasaki Harbor Medical Center
Nagasaki, 850-8555
Nagoya Ekisaikai Hospital
Nagoya, 454-8502
Japanese Red Cross Nagoya Daini Hospital
Nagoya, 466-8650
Ohama Daiichi Hospital
Naha, 900-0005
Naha City Hospital
Naha, 902-8511
Takanohara Central Hospital
Nara, 631-0805
JCHO Nihonmatsu Hospital
Nihonmatsu, 964-0871
Meiwa Hospital
Nishinomiya, 663-8186
Ohyama Memorial Hospital
Nishiwaki, 679-0321
Ogawa Cardiovascular Internal Medicine Clinic
Obihiro, 080-0871
Ogaki Municipal Hospital
Ōgaki, 503-8502
Shimada Hospital
Ogōri-shimogō, 838-0141
Oita Prefectural Hospital
Ōita, 870-8511
Kouhoukai Takagi Hospital
Ōkawa, 831-0016
Ome Municipal General Hospital
Ōme, 198-0042
Omihachiman Community Medical Center
Ōmihachiman, 523-0082
National Hospital Organization Nagasaki Medical Center
Ōmura, 856-8562
Social Corporation Keigakukai Minamiosaka Hospital
Osaka, Osaka, 559-0012
Sakurabashi Watanabe Hospital
Osaka, 530-0001
Osaka City Juso Hospital
Osaka, 532-0034
Kitada Clinic
Osaka, 538-0044
Osaka Police Hospital
Osaka, 543-0035
Osaka General Medical Center
Osaka, 558-8558
National Hospital Organization Osaka Minami Medical Center
Osaka, 586-0008
Sato Hospital
Osaka, 989-6143
Omori Sanno Hospital
Ōta-ku, 143-0023
Otaru Kyokai Hospital
Otaru, 047-8510
JCHO Shiga Hospital
Ōtsu, 520-0846
Saga-Ken Medical Centre Koseikan
Saga, 840-8571
Saitama City Hospital
Saitama, 336-8522
Saitama Memorial Hospital
Saitama, 337-0012
Saku Central Hospital Advanced Care Center
Saku, 385-0051
Kin-ikyo Chuo Hospital
Sapporo, 007-8505
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
Sapporo, 060-0033
National Hospital Organization Hokkaido Medical Center
Sapporo, 063-0005
Sapporo Nishimaruyama Hospital
Sapporo, 064-8557
Miyanomori Memorial Hospital
Sapporo, 064-8570
Hokkaido Cardiovascular Hospital
Sapporo, 064-8622
Shukokai Internal Medicine Sato Hospital
Sendai, 980-0011
KKR Tohoku Kosai Hospital
Sendai, 980-0803
National Hospital Organization Sendai Medical Center
Sendai, 983-8520
Tosei General Hospital
Seto, 489-8642
National Hospital Organization Kanmon Medical Center
Shimonoseki, 752-8510
Dokkyo Medical University Hospital
Shimosuga, 321-0293
Tokyo Heart Center
Shinagawa-Ku, 141-0001
Showa University Hospital
Shinagawa-Ku, 142-8666
Center Hospital of the National Center for Global Health and Medicine
Shinjuku-Ku, 162-8655
Shirakawa Hospital
Shirakawa, 961-0092
Iwate Medical University Hospital
Shiwa-gun, 020-8505
National Hospital Organization Shizuoka Medical Center
Shizuoka, 411-8611
Ikeda Kinen Hospital
Sukagawa, 962-0001
Iwase General Hospital
Sukagawa, 962-8503
Hyogo Prefectural Awaji Medical Center
Sumoto, 656-0021
Nagano Prefectural Shinshu Medical Hospital
Suzaka, 382-0000
National Hospital Organization Disaster Medical Center
Tachikawa, 190-0014
Social Insurance Tagawa Hospital
Tagawa, 826-8585
Kagawa Prefectural Central Hospital
Takamatsu, 760-8557
Kouseiren Takaoka Hospital
Takaoka, 933-8555
Medical Corporation Aishinkai Higashi Takarazuka Satoh Hospital
Takarazuka, 665-0873
Kan-etsu Chu-oh Hospital
Takasaki, 370-3513
Takatsuki General Hospital
Takatsuki, 569-1192
National Hospital Organization Minami Wakayama Medical Center
Tanabe, 646-8558
Tenri Hospital
Tenri, 632-8552
Kuwanomi Hongou Clinic
Tokorozawa, 359-0022
Saino Clinic
Tokorozawa, 359-1141
Tokorozawa Heart Center
Tokorozawa, 359-1142
Tokushima University Hospital
Tokushima, 770-8503
Tokushima Prefectural Central Hospital
Tokushima, 770-8539
Nerima General Hospital
Tokyo, 176-8530
Tomakomai City Hospital
Tomakomai, 053-8567
Public Tomioka General Hospital
Tomioka, 370-2393
National Hospital Organization Ehime Medical Center
Tōon, 791-0281
Yamaguchi Clinic
Toshima-ku, 170-0001
Yayoigaoka Kage Hospital
Tosu, 841-0005
National Hospital Organization Toyohashi Medical Center
Toyohashi, 440-8510
TOYOTA Memorial Hospital
Toyota, 471-0821
Tsukuba Memorial Hospital
Tsukuba, 300-2622
Okinawa Prefectural Chubu Hospital
Uruma, 904-2293
National Hospital Organization Tochigi Medical Center
Utsunomiya, 320-8580
Uwajima City Hospital
Uwajima, 798-8510
Wakayama Rosai Hospital
Wakayama, 640-8505
Nagata Hospital
Yanagawa, 832-0059
Kumamoto General Hospital
Yatsushiro, 866-8660
Yokohama Municipal Citizen's Hospital
Yokohama, 221-0855
Yokohama Rosai Hospital
Yokohama, 222-0036
Showa University Fujigaoka Hospital
Yokohama, 227-8501
JCHO Yokohama Chuo Hospital
Yokohama, 231-8553
Yokohama City Minato Red Cross Hospital
Yokohama, 231-8682
Yokohama City University Medical Center
Yokohama, 232-0024
Saiseikai Yokohamashi Nanbu Hospital
Yokohama, 234-8503
Yokohama Minami Kyousai Hospital
Yokohama, 236-0037
National Hospital Organization Yokohama Medical Center
Yokohama, 245-8575
Yokohama Sakae Kyosai Hospital
Yokohama, 247-8581
About this study
Official title: 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.
- Conditions
- Atrial Fibrillation
- Being tested
- Du-176b, placebo
- Keywords
- anticoagulants, DU-176b, edoxaban, factor Xa, oral, prevention, atrial fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Du-176bDrug
Also called edoxaban
DU-176b orally administered at a dose of 15 mg once daily.
placeboDrug
Placebo orally administered once daily.
| Study group | Role | What they receive |
|---|---|---|
| DU-176b 15 mg group | Experimental | DU-176b orally administered at a dose of 15 mg once daily. Receives: Drug: Du-176b |
| Placebo group | Placebo comparator | Placebo orally administered once daily. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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
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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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."
Measured: 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
Measured: Week 8: Predose,1-3 hours (h) and 4-8 h postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2016 (estimated)
- Study start5 Aug 2016
- Primary completion27 Dec 2019
- Study completion27 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 984 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Leader, Study director, Daiichi Sankyo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02801669
- Sponsor's protocol ID
- DU176b-C-J316
- Other IDs
- 163266
- Status last verified
- Nov 2020
- First submitted
- 13 Jun 2016
- Last updated
- 19 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: 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/
Publications
Okumura K, Akao M, Fukuzawa M, Igawa Y, Hayashi T, Yamashita T. Association of Edoxaban Pharmacokinetics With Bleeding in Older Patients With Atrial Fibrillation Treated With Low-Dose Edoxaban: A Post Hoc Analysis of a Randomized Controlled Trial. J Am Heart Assoc. 2026 May 19;15(10):e042950. doi: 10.1161/JAHA.125.042950. Epub 2026 May 14.
PubMed 42132160Akao 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.
PubMed 38240204Cochrane 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.
PubMed 36700520Mikami 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.
PubMed 36056729Kuroda 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.
PubMed 35416910Yoshida 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.
PubMed 35226559Okumura 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.
PubMed 32865374
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02801669
- Acronym / sponsor ID
- DU176b-C-J316
- Conditions
- Atrial Fibrillation
- Keywords
- anticoagulants, DU-176b, edoxaban, factor Xa, oral, prevention, atrial fibrillation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 984 participants (actual)
- Lead sponsor
- Daiichi Sankyo Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Aug 2016 (actual)
- Primary completion
- 27 Dec 2019 (actual)
- Study completion
- 27 Dec 2019 (actual)
- First posted
- 16 Jun 2016 (estimated)
- Results
- Posted 19 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DU-176b 15 mg group | Experimental | Drug: Du-176bDU-176b orally administered at a dose of 15 mg once daily. |
| Placebo group | Placebo comparator | Drug: placeboPlacebo orally administered once daily. |
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Patients with Nonvalvular Atrial Fibrillation (NVAF) aged 80 years or older who are ineligible for available oral anticoagulation therapy
Key exclusion criteria (3 listed)
- Patients with active bleeding
- Patients who have poorly controlled hypertension
- Patients who have liver dysfunction accompanied with disorder of blood coagulation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Du-176bAlso: edoxabanDU-176b orally administered at a dose of 15 mg once daily. | Drug | DU-176b 15 mg group |
| placeboPlacebo orally administered once daily. | Drug | Placebo group |
Primary outcome
Number of Participants With a Composite Endpoint of Stroke and Systemic Embolic Events (SEE) in Participants Who Were Administered DU-176b Compared With Placebo
Time frame: 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)
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).
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
Time frame: 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)
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).
9 secondary outcomes
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Week 8: Predose,1-3 hours (h) and 4-8 h postdose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42132160Okumura K, Akao M, Fukuzawa M, Igawa Y, Hayashi T, Yamashita T. Association of Edoxaban Pharmacokinetics With Bleeding in Older Patients With Atrial Fibrillation Treated With Low-Dose Edoxaban: A Post Hoc Analysis of a Randomized Controlled Trial. J Am Heart Assoc. 2026 May 19;15(10):e042950. doi: 10.1161/JAHA.125.042950. Epub 2026 May 14.
- Derived from this study: PubMed 38240204Akao 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.
- Derived from this study: PubMed 36700520Cochrane 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.
- Derived from this study: PubMed 36056729Mikami 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.
- Derived from this study: PubMed 35416910Kuroda 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.
- Derived from this study: PubMed 35226559Yoshida 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.
- Derived from this study: PubMed 32865374Okumura 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.
- Individual participant dataSharing planned: Yes. 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/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Leader study director
Daiichi Sankyo
164 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Du-176b in people with Atrial Fibrillation, run by Daiichi Sankyo Co., Ltd. at 164 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 1 inclusion and 3 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 19 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 164 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. Some participants in this study may receive a placebo. 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 Nov 2020). 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?
Number of Participants With a Composite Endpoint of Stroke and Systemic Embolic Events (SEE) in Participants Who Were Administered DU-176b Compared With Placebo (time frame: 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)). The study lists 2 primary outcomes in all. 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 NCT02801669, which also lists 7 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 19 Nov 2020.