UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021973 |
|---|---|
| Receipt number | R000025329 |
| Scientific Title | Multicenter prospective study on the usefulness and safety of edoxaban replacement before the endoscopic therapy with high-risk bleeding group during anticoagulant therapy with warfarin |
| Date of disclosure of the study information | 2016/04/18 |
| Last modified on | 2018/10/20 13:30:35 |
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Basic information
Public title
Multicenter prospective study on the usefulness and safety of edoxaban replacement before the endoscopic therapy with high-risk bleeding group during anticoagulant therapy with warfarin
Acronym
Disestive disorders requiring the endoscopic therapy in high-risk bleeding group
Scientific Title
Multicenter prospective study on the usefulness and safety of edoxaban replacement before the endoscopic therapy with high-risk bleeding group during anticoagulant therapy with warfarin
Scientific Title:Acronym
Disestive disorders requiring the endoscopic therapy in high-risk bleeding group
Region
| Japan |
Condition
Condition
Disestive disorders requiring the endoscopic therapy in high-risk bleeding group
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To verify that usefulness and safety of the endoscopic therapy by edoxaban replacement versus heparin replacement in high-risk bleeding group from anticoagulant therapy with warfarin
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The frequency of bleeding for 2 weeks after the endoscopic therapy
Key secondary outcomes
The frequency of thrombotic events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
edoxaban replacement in high-risk bleeding group from anticoagulant therapy with warfarin.
Interventions/Control_2
heparin replacement in high-risk bleeding group from anticoagulant therapy with warfarin
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients in the anticoagulation therapy with warfarin is needed the endoscopic therapy in high-risk bleeding group, and meet following criteria:
1)The patient written consent has been obtained
2)The patient over the age of 20
3) The patient's platelet 50000 / mm3 or more
Key exclusion criteria
1) The patient who has taken warfarin after heart valve replacement
2) The patient with severe comorbidity
3) The patient cannot be obtained with informed consent
4) The patient prohibited the participant of this study by their research investigator
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichi Hashimoto |
Organization
Kagoshima University
Division name
Digestive and Lifestyle Diseases
Zip code
Address
8-35-1 Sakuragaoka, Kagoshima
TEL
0992755326
kumdsh@m.kufm.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinichi Hashimoto |
Organization
Kagoshima University
Division name
Digestive and Lifestyle Diseases
Zip code
Address
8-35-1 Sakuragaoka, Kagoshima
TEL
0992755326
Homepage URL
kumdsh@m.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Digestive and Lifestyle Diseases, Kagoshima University
Institute
Department
Personal name
Funding Source
Organization
Digestive and Lifestyle Diseases, Kagoshima University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 04 | Month | 18 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 04 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 18 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 18 | Day |
Last modified on
| 2018 | Year | 10 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025329
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
