UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000016387
Receipt No. R000019034
Scientific Title Special Drug Use Surveillance of LIXIANA Tablet - Long-term use in patients with venous thromboembolism -
Date of disclosure of the study information 2015/01/30
Last modified on 2019/10/04 (Ver. 16)

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Basic information
Public title Special Drug Use Surveillance of LIXIANA Tablet
- Long-term use in patients with venous thromboembolism -
Acronym ETNA-VTE-Japan
Scientific Title Special Drug Use Surveillance of LIXIANA Tablet
- Long-term use in patients with venous thromboembolism -
Scientific Title:Acronym ETNA-VTE-Japan
Region
Japan

Condition
Condition Treatment and recurrence prevention of venous thromboembolism [VTE] (deep vein thrombosis [DVT] and pulmonary thromboembolism [PTE])
Classification by specialty
Cardiology Vascular surgery Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 investigate or establish the safety and effectiveness of LIXIANA newly prescribed and administered for 1 year in the clinical setting.
<The following will be the subject of special monitoring:>
Incidence of bleeding adverse events
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 bleeding AEs
Efficacy
･Occurrence of recurrent VTE
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 [3]) will be considered for admission to the study:
[1] Patients who have just started to receive LIXIANA for the first time for the treatment and secondary (recurrence) prevention of VTE (DVT and PTE)
[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 have given written informed consent to the study
Key exclusion criteria None
Target sample size 1500

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 103-8426, Japan
TEL +81-3-6225-1044
Email wada.kento.k8@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 103-8426, 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 01 Month 30 Day

Related information
URL releasing protocol N.A.
Publication of results Partially published

Result
URL related to results and publications https://www.jstage.jst.go.jp/article/circj/advpub/0/advpub_CJ-18-1362/_article/-char/en
Number of participants that the trial has enrolled 1732
Results 
The results confirm no major concerns about the safety and effectiveness of edoxaban in Japanese patients with VTE in the first 3 months of treatment.
Safety and effectiveness profiles of edoxaban in patients receiving the low dose (30 mg/day), generally administered to patients with high bleeding risk, were similar to those of the standard dose (60 mg/day).
Results date posted
2019 Year 10 Month 04 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2019 Year 05 Month 10 Day
Baseline Characteristics 
In the safety analysis set, 39.4% of patients were aged >=75 years, 58.2% had body weight <=60 kg, and 22.2% had creatinine clearance <50 mL/min.
Participant flow 
A total of 1,732 patients attending 281 institutions were enrolled. At 3 months, data from 1,724 patients had been collected and the data set was finalized. 
Data from 21 of these patients were excluded from the safety analysis set for the following reasons: serious protocol violation (14 patients), safety evaluation not performed (5 patients), and withdrawal of consent (2 patients). Therefore, the safety analysis set comprised data from 1,703 patients. 
Data from 4 of these 1,703 patients were excluded from the effectiveness analysis set for the following reasons: effectiveness evaluation not performed (2 patients) and off-label use (2 patients). Therefore, the effectiveness analysis set comprised data from 1,699 patients.
Adverse events 
ADRs were reported in 8.7% of patients. Serious ADRs were reported in 2.4%
Outcome measures 
Safety
The incidence of bleeding adverse events was 6.3%, with a similar incidence between patients who received low-dose edoxaban (30 mg/day) and patients who received the standard dose (60 mg/day) (6.6% and 5.8%, respectively). 
The incidence of major bleedingwas 1.4%. 

Effectiveness
The incidence of VTE recurrence and symptomatic VTE recurrence in the on-treatment population was 0.8% and 0.4%, respectively. 
The incidence of VTE recurrence in the on-treatment population was not higher in patients who received low-dose edoxaban (30 mg/day) than in patients who received the standard dose (60 mg/day) (0.4% and 1.5%, respectively)
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2015 Year 01 Month 21 Day
Date of IRB
2014 Year 03 Month 04 Day
Anticipated trial start date
2015 Year 02 Month 01 Day
Last follow-up date
2018 Year 07 Month 31 Day
Date of closure to data entry
2019 Year 05 Month 09 Day
Date trial data considered complete
2019 Year 06 Month 02 Day
Date analysis concluded

Other
Other related information 1.Demographic
2.Extent of exposure to LIXIANA, medical treatments for VTE and other medications
3.Efficacy: Occurrence of recurrent VTE
4.Safety: Adverse events (including bleeding AEs)

Management information
Registered date
2015 Year 01 Month 30 Day
Last modified on
2019 Year 10 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019034