UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050893 |
|---|---|
| Receipt number | R000058002 |
| Scientific Title | Edoxaban for venous thromboembolism |
| Date of disclosure of the study information | 2023/04/20 |
| Last modified on | 2023/10/19 15:38:13 |
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Basic information
Public title
Edoxaban for venous thromboembolism
Acronym
Edoxaban for venous thromboembolism
Scientific Title
Edoxaban for venous thromboembolism
Scientific Title:Acronym
Edoxaban for venous thromboembolism
Region
| Japan |
Condition
Condition
venous thromboembolism
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate edoxaban for venous thromboembolism.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Recurrent VTE, Major bleeding
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
VTE
Key exclusion criteria
Anticoagulation other than for VTE
Target sample size
8000
Research contact person
Name of lead principal investigator
| 1st name | Yugo |
| Middle name | |
| Last name | Yamashita |
Organization
Graduate School of Medicine, Kyoto University.
Division name
Department of Cardiovascular Medicine
Zip code
606-8507
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
TEL
+81-75-751-4254
yyamashi@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Yugo |
| Middle name | |
| Last name | Yamashita |
Organization
Graduate School of Medicine, Kyoto University.
Division name
Department of Cardiovascular Medicine
Zip code
606-8507
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
TEL
+81-75-751-4254
Homepage URL
yyamashi@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University.
Institute
Department
Personal name
Funding Source
Organization
Daiichi Sankyo
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel
ethcom@kuhp.kyoto-u.ac.jp
ethcom@kuhp.kyoto-u.ac.jp
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
| 2023 | Year | 04 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
| 2023 | Year | 02 | Month | 21 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 29 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 29 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
Management information
Registered date
| 2023 | Year | 04 | Month | 20 | Day |
Last modified on
| 2023 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058002
