UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030744 |
|---|---|
| Receipt number | 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 16:41:51 |
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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.
Region
| Japan |
Condition
Condition
Non-valvular atrial fibrillation
Classification by specialty
| Medicine in general | Cardiology | Neurology |
| Gastrointestinal surgery |
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
| Not applicable |
Age-upper limit
| Not applicable |
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
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | Hisashi |
| Middle name | |
| Last name | Nakagaki |
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
| 1st name | Masafumi |
| Middle name | |
| Last name | Kobayashi |
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 or person
Institute
Daiichi Sankyo Co., Ltd
Medical Science Department
Institute
Department
Personal name
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
| 2018 | Year | 01 | Month | 10 | Day |
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.
Results date posted
| 2020 | Year | 06 | Month | 29 | Day |
Results Delayed
Results Delay Reason
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.
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.
Adverse events
Adverse events were not evaluated in this study.
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.
Plan to share IPD
not planned
IPD sharing Plan description
not planned
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 10 | Month | 20 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 20 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2017 | Year | 10 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 03 | Month | 27 | Day |
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
Management information
Registered date
| 2018 | Year | 01 | Month | 10 | Day |
Last modified on
| 2020 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034955
