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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000017011
Receipt No. R000019728
Scientific Title Special Drug Use Surveillance of LIXIANA Tablet and OD Tablet - Long-term use in patients with non-valvular atrial fibrillation -
Date of disclosure of the study information 2015/04/12
Last modified on 2019/04/04

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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

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 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 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 kogure.seiji.ia@daiichisankyo.co.jp

Public contact
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

Sponsor
Institute DAIICHI SANKYO COMPANY, LIMITED
Institute
Department

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 N.A.
Address N.A.
Tel N.A.
Email N.A.

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 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

Progress
Recruitment status No longer recruiting
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
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 04 Month 04 Day


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

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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