UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055684 |
|---|---|
| Receipt number | R000063489 |
| Scientific Title | The Prescribing Patterns of Edoxaban15mg for Very Elderly Non-Valvular Atrial Fibrillation (NVAF) Patients in Japan. |
| Date of disclosure of the study information | 2024/10/02 |
| Last modified on | 2025/10/01 15:24:19 |
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Basic information
Public title
The Prescribing Patterns of Edoxaban15mg for Very Elderly Non-Valvular Atrial Fibrillation (NVAF) Patients in Japan.
Acronym
The Prescribing Patterns of Edoxaban15mg for Very Elderly Non-Valvular Atrial Fibrillation (NVAF) Patients in Japan.
Scientific Title
The Prescribing Patterns of Edoxaban15mg for Very Elderly Non-Valvular Atrial Fibrillation (NVAF) Patients in Japan.
Scientific Title:Acronym
The Prescribing Patterns of Edoxaban15mg for Very Elderly Non-Valvular Atrial Fibrillation (NVAF) Patients in Japan.
Region
| Japan |
Condition
Condition
Non-Valvular Atrial Fibrillation
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In the real world,
To observe the trends in prescription share for each DOAC, WF, and no OAC group before and after launching edoxaban 15mg in all NVAF patients aged 80 years and older.
To observe the characteristics of patients prescribed edoxaban15mg for elderly NVAF.
Basic objectives2
Others
Basic objectives -Others
Descriptive statistics of patient background.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To observe the characteristics (bleeding risk factor, etc) of patients prescribed edoxaban15mg for elderly NVAF.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 80 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Jan.2019-Dec.2023
Include patients who meet all of the following conditions.
1.Patients aged 80 years and older.
2.Patients with an ICD10 code for atrial fibrillation.
Key exclusion criteria
Exclude patients who meet any of the following conditions.
1.Patients with diagnosis of valvular atrial fibrillation, chronic rheumatic heart disease.
2.Patients with history of mechanical heart valves.
3.Patients with diagnosis of deep vein thrombosis and pulmonary thromboembolism
4.Patients with history of total knee replacement, total hip replacement and hip fracture surgery.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Yoshi |
| Middle name | |
| Last name | Yasuda |
Organization
Daiichi Sankyo Co., Ltd.
Division name
Primary Medical Science Department
Zip code
103-8426
Address
3-5-1, Nihonbashi-Honcho, Chuo-ku, Tokyo, Japan
TEL
03-6225-1111
yoshi.yasuda@daiichisankyo.com
Public contact
Name of contact person
| 1st name | Masako |
| Middle name | |
| Last name | Sugimoto |
Organization
Daiichi Sankyo Co., Ltd.
Division name
Primary Medical Science Department
Zip code
103-8426
Address
3-5-1, Nihonbashi-Honcho, Chuo-ku, Tokyo, Japan
TEL
03-6225-1111
Homepage URL
masako.sugimoto@daiichisankyo.com
Sponsor or person
Institute
Daiichi Sankyo Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Daiichi Sankyo Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Daiichi Sankyo Co., Ltd.
Address
3-5-1, Nihonbashi-Honcho, Chuo-ku, Tokyo, Japan
Tel
0362251111
masako.sugimoto@daiichisankyo.com
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
| 2024 | Year | 10 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
5027
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 08 | Month | 21 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 06 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 25 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective cohort study
Management information
Registered date
| 2024 | Year | 10 | Month | 01 | Day |
Last modified on
| 2025 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063489
