UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016387 |
|---|---|
| Receipt number | 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 18:03:50 |
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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
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
ouchi.hirohide.bm@daiichisankyo.co.jp
Sponsor or person
Institute
DAIICHI SANKYO COMPANY, LIMITED
Institute
Department
Personal name
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.
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019034
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