UMIN-CTR Clinical Trial
| Recruitment status | Completed |
| Unique ID issued by UMIN | UMIN000030744 |
| Receipt No. | R000034955 |
| Scientific Title | Real world survey of Edoxaban for non-valvular atrial fibrillation patients using a Japanese healthcare database. |
| Date of disclosure of the study information | 2018/01/10 |
| Last modified on | 2020/06/29 (Ver. 10) |
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| Basic information | ||
| Public title | Real world survey of Edoxaban for non-valvular atrial fibrillation patients using a Japanese healthcare database. | |
| Acronym | Real world survey of Edoxaban for non-valvular atrial fibrillation patients using a Japanese healthcare database. | |
| Scientific Title | Real world survey of Edoxaban for non-valvular atrial fibrillation patients using a Japanese healthcare database. | |
| Scientific Title:Acronym | Real world survey of Edoxaban for non-valvular atrial fibrillation patients using a Japanese healthcare database. | |
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| Condition | |||||
| Condition | Non-valvular atrial fibrillation | ||||
| Classification by specialty |
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| Classification by malignancy | Others | ||||
| Genomic information | NO | ||||
| Objectives | |
| Narrative objectives1 | The objective of the study is to clarify the actual condition of patients using Edoxaban, the onset situation of bleeding events and to compare with the patients using Warfarin and not using anti-coagulant. |
| Basic objectives2 | Others |
| Basic objectives -Others | Retrospective study |
| Trial characteristics_1 | Exploratory |
| Trial characteristics_2 | Pragmatic |
| Developmental phase | Not applicable |
| Assessment | |
| Primary outcomes | 1,stroke
2,systemic embolism 3,bleeding |
| Key secondary outcomes | |
| Base | |
| Study type | Observational |
| Study design | |
| Basic design | |
| Randomization | |
| Randomization unit | |
| Blinding | |
| Control | |
| Stratification | |
| Dynamic allocation | |
| Institution consideration | |
| Blocking | |
| Concealment | |
| Intervention | |
| No. of arms | |
| Purpose of intervention | |
| Type of intervention | |
| Interventions/Control_1 | |
| Interventions/Control_2 | |
| Interventions/Control_3 | |
| Interventions/Control_4 | |
| Interventions/Control_5 | |
| Interventions/Control_6 | |
| Interventions/Control_7 | |
| Interventions/Control_8 | |
| Interventions/Control_9 | |
| Interventions/Control_10 | |
| Eligibility | ||||
| Age-lower limit |
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| Age-upper limit |
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| Gender | Male and Female | |||
| Key inclusion criteria | Patients with non-valvular atrial fibrillation | |||
| Key exclusion criteria | 1, Patients who underwent total knee replacement surgery
2, Patients who underwent total hip replacement surgery 3, Patients who underwent hip fracture surgery 4, Patients who have an artificial heart valves 5, Patients who have been given the diagnosis of rheumatic mitral valve diseases 6, Patients who have stroke, systemic embolism events, and/or bleeding events |
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| Target sample size | 5000 | |||
| Research contact person | |||||||
| Name of lead principal investigator |
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| Organization | Daiichi Sankyo Co., Ltd | ||||||
| Division name | Medical Science Department | ||||||
| Zip code | 103-8426 | ||||||
| Address | 3-5-1 Nihonbashi-honcho Chuo-ku, Tokyo, 103-8426, Japan | ||||||
| TEL | 03-6225-1053 | ||||||
| nakagaki.hisashi.sh@daiichisankyo.co.jp | |||||||
| Public contact | |||||||
| Name of contact person |
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| Organization | Linical Co., Ltd | ||||||
| Division name | Corporate Planning Department | ||||||
| Zip code | 532-0003 | ||||||
| Address | 1-6-1 Miyahara Yodogawa-ku, Osaka, 532-0003, Japan | ||||||
| TEL | 06-6150-2478 | ||||||
| Homepage URL | |||||||
| kobayashi-masafumi@linical.co.jp | |||||||
| Sponsor | |
| Institute | Daiichi Sankyo Co., Ltd
Medical Science Department |
| Institute | |
| Department | |
| Funding Source | |
| Organization | Daiichi Sankyo Co., Ltd
Medical Science Department |
| Organization | |
| Division | |
| Category of Funding Organization | Profit organization |
| Nationality of Funding Organization | Japan |
| Other related organizations | |
| Co-sponsor | |
| Name of secondary funder(s) | |
| IRB Contact (For public release) | |
| Organization | N/A |
| Address | N/A |
| Tel | 0 |
| @ | |
| Secondary IDs | |
| Secondary IDs | NO |
| Study ID_1 | |
| Org. issuing International ID_1 | |
| Study ID_2 | |
| Org. issuing International ID_2 | |
| IND to MHLW | |
| Institutions | |
| Institutions | |
| Other administrative information | |||||||
| Date of disclosure of the study information |
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| Related information | |
| URL releasing protocol | https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000034955 |
| Publication of results | Unpublished |
| Result | |||||||
| URL related to results and publications | https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000034955 | ||||||
| Number of participants that the trial has enrolled | 4414 | ||||||
| Results | Total of 4,144 edoxaban-treated patients were matched with same number of warfarin patients and no-anticoagulant patients. Median follow-up period for the edoxaban arm, warfarin arm, and no-anticoagulant arm was 82, 39, and 324 days. For the comparison of the edoxaban and warfarin arms, and edoxaban and no-anticoagulant arm, no difference was found in the incidence of stroke/systemic embolism. The findings are limited by the short mean follow-up period in both treatment arms. |
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| Results date posted |
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| Results Delayed | |||||||
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| Date of the first journal publication of results | |||||||
| Baseline Characteristics | Mean age in the edoxaban, warfarin and no-anticoagulant arm was 73.7, 74.3, and 74.7 years; the proportion of men was 56 percent in each arm. Mean body weight was 57.3, 56.8, and 54.0 kg. Mean CHADS2 score and CHA2DS2-VASc score for each arm were 2.0 and 3.4. Median follow-up period in the edoxaban, warfarin, and no-anticoagulant arms was 82, 39, and 328 days, respectively, which diverged from expected duration for chronic anticoagulant treatment. |
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| Participant flow | In 18,650,596 inpatient and outpatient patients included in the medical database between April 2008 and December 2016, 319,295 patients were defined as having NVAF. In NVAF, 4,414 patients were administered edoxaban, 36,431 patients were administered warfarin, and 17,655 patients did not receive any anticoagulants. The 4,414 patients in warfarin arm and the no-anticoagulant arm were matched against 4,414 patients in the edoxaban arm. |
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| Adverse events | Adverse events were not evaluated in this study. |
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| Outcome measures | The incidence of stroke/systemic embolism event in edoxaban arm, warfarin arm, and no-anticoagulant arm was 2.4%, 2.5%, and 3.7% per year, respectively. The incidence of bleeding events was 1.0%, 1.0%, and 4.5% per year. |
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| Plan to share IPD | not planned | ||||||
| IPD sharing Plan description | not planned | ||||||
| Progress | |||||||
| Recruitment status | Completed | ||||||
| Date of protocol fixation |
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| Date of IRB |
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| Anticipated trial start date |
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| Last follow-up date |
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| Date of closure to data entry | |||||||
| Date trial data considered complete | |||||||
| Date analysis concluded |
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| Other | |
| Other related information | <Study design>
Retrospective comparative study <Arm> 1, NVAF patients who treated with Edoxaban after Sep 2014 2, NVAF patients who treated with Warfarin after Oct 2008 3, NVAF patients who did not receive anti-coagulants after Apr 2008 <Date of IRB> N/A |
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| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034955 |
