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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000021973
Receipt No. 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

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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&#39;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
Email 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
Email kumdsh@m.kufm.kagoshima-u.ac.jp

Sponsor
Institute Digestive and Lifestyle Diseases, Kagoshima University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025329

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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