UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Shinichi Hashimoto
Organization	Kagoshima University
Division name	Digestive and Lifestyle Diseases
Address	8-35-1 Sakuragaoka, Kagoshima
TEL	0992755326
Email	kumdsh@m.kufm.kagoshima-u.ac.jp

Public contact
Name of contact person	Shinichi Hashimoto
Organization	Kagoshima University
Division name	Digestive and Lifestyle Diseases
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 04 Month 18 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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