UMIN-CTR Clinical Trial

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

Non-valvular atrial fibrillation

Classification by specialty

Medicine in general	Cardiology	Neurology
Gastrointestinal surgery

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

1,stroke
2,systemic embolism
3,bleeding

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Daiichi Sankyo Co., Ltd
Medical Science Department

Institute

Department

Personal name

Organization

Daiichi Sankyo Co., Ltd
Medical Science Department

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

N/A

Address

N/A

Tel

0

Email

@

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

01

Month

10

Day

URL releasing protocol

https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000034955

Publication of results

Unpublished

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

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 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

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