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Name:
UMIN ID:

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 2019/03/29

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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
Email 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
Email 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
Email @

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
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 5000
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
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
2019 Year 03 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034955

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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