UMIN-CTR Clinical Trial

Public title

Special Drug Use Surveillance of
LIXIANA Tablet and OD Tablet
- Long-term use in patients with non-valvular atrial fibrillation -

Acronym

ETNA-AF-Japan

Scientific Title

Special Drug Use Surveillance of
LIXIANA Tablet and OD Tablet
- Long-term use in patients with non-valvular atrial fibrillation -

Scientific Title:Acronym

ETNA-AF-Japan

Region

Japan

Condition

Prevention of ischemic stroke and systemic embolism in patients with non-valvular atrial fibrillation.

Classification by specialty

Cardiology	Neurology	Neurosurgery
Cardiovascular surgery

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

investigate or establish the safety and effectiveness of LIXIANA Tablet and OD Tablet newly prescribed and administered for 2 years for the prevention of ischemic stroke and systemic embolism in patients with nonvalvular atrial fibrillation(NVAF) in the clinical setting.
The following will be the subject of special monitoring:
･Incidence of bleeding adverse events (AEs)
･Incidence of ischemic stroke and systemic embolism

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase IV

Primary outcomes

Safety
(1)Occurrence of individual ADRs
(2)Occurrence of serious AEs
(3)Occurrence of ADRs by factors
(4)Occurrence of bleeding AEs
(5)Occurrence of bleeding AEs by factors

Efficacy
(1) Occurrence of endpoint events (death, stroke [excluding TIA], systemic embolism, and myocardial infarction)
(2) Occurrence of endpoint events by factors

Safety and efficacy in special populations
･Data from the study will be analyzed to investigate the safety and efficacy of LIXIANA in pediatric patients, elderly patients, pregnant/delivering women, patients with hepatic impairment and those with renal impairment.

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 who meet the following
requirements when starting to
receive LIXIANA (at the time of
enrollment for [4]) will be
considered for admission to the
study:
[1]Patients with NVAF who have just started to receive LIXIANA for the first time to prevent ischemic stroke and systemic embolism
[2] Patients who are to start
treatment with LIXIANA during the
period of contract (as per the signed
contract between the institution and
the sponsor) and during the
enrollment period
[3]Patients who will be available for long-term follow-up
[4]Patients who have given written informed consent to the study

Key exclusion criteria

None

Target sample size

10000

Name of lead principal investigator

1st name	Kento
Middle name
Last name	Wada

Organization

DAIICHI SANKYO COMPANY, LIMITED

Division name

Post Marketing Study Department

Zip code

103-8426

Address

3-5-1, Nihonbashi Honcho, Chuo-ku, Tokyo, Japan

TEL

+81-3-6225-1044

Email

wada.kento.k8@daiichisankyo.co.jp

Name of contact person

1st name	Hirohide
Middle name
Last name	Ouchi

Organization

DAIICHI SANKYO COMPANY, LIMITED

Division name

Post Marketing Study Department

Zip code

103-8426

Address

3-5-1, Nihonbashi Honcho, Chuo-ku, Tokyo, Japan

TEL

+81-3-6225-1044

Homepage URL

Email

ouchi.hirohide.bm@daiichisankyo.co.jp

Institute

DAIICHI SANKYO COMPANY, LIMITED

Institute

Department

Personal name

Organization

DAIICHI SANKYO COMPANY, LIMITED

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

N.A.

Email

N.A.

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

2015

Year

04

Month

12

Day

URL releasing protocol

Publication of results

Partially published

URL related to results and publications

Number of participants that the trial has enrolled

11569

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

Recruitment status

Completed

Date of protocol fixation

2015

Year

03

Month

20

Day

Date of IRB

2014

Year

03

Month

04

Day

Anticipated trial start date

2015

Year

04

Month

13

Day

Last follow-up date

2019

Year

09

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

1.Demographic
2.Extent of exposure to LIXIANA,anticoagulant/antiplatelet and other medications
3.Efficacy:Occurrence of endpoint events (death, stroke [excluding TIA], systemic embolism, and myocardial infarction)
4.Safety:Occurrence of AEs (including bleeding AEs)

Registered date

2015

Year

04

Month

01

Day

Last modified on

2019

Year

10

Month

04

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019728