UMIN-CTR Clinical Trial

Basic information
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
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

Objectives
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

Assessment
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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
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

Research contact person
Name of lead principal investigator	1st name Middle name Last name Wada
Organization	DAIICHI SANKYO COMPANY, LIMITED
Division name	Post Marketing Study Department
Zip code
Address	3-5-1, Nihonbashi Honcho, Chuo-ku, Tokyo, Japan
TEL	+81-3-6225-1044
Email	wada.kento.k8@daiichisankyo.co.jp

Public contact
Name of contact person	1st name Middle name Last name Ouchi
Organization	DAIICHI SANKYO COMPANY, LIMITED
Division name	Post Marketing Study Department
Zip code
Address	3-5-1, Nihonbashi Honcho, Chuo-ku, Tokyo, Japan
TEL	+81-3-6225-1044
Homepage URL
Email	ouchi.hirohide.bm@daiichisankyo.co.jp

Sponsor
Institute	DAIICHI SANKYO COMPANY, LIMITED
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	DAIICHI SANKYO COMPANY, LIMITED
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
Address
Tel
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	2015 Year 04 Month 12 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
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	2015 Year 03 Month 20 Day
Date of IRB
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
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)

Management information
Registered date	2015 Year 04 Month 01 Day
Last modified on	2019 Year 10 Month 04 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019728

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