UMIN-CTR Clinical Trial

Basic information
Public title	A study on efficacy and safety of Edoxaban on high-risk gastrointestinal endoscopic procedures
Acronym	Edoxaban study
Scientific Title	A study on efficacy and safety of Edoxaban on high-risk gastrointestinal endoscopic procedures
Scientific Title:Acronym	Edoxaban study
Region	Japan

Condition
Condition	All diseases that require high-risk gastrointestinal endoscopic procedures such as endoscopic polypectomy, endoscopic mucosal resection, endoscopic submucosal dissection or endoscopic mucosal ablation
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To reveal the rate of bleeding or thromboembolism during the periendoscopic period when using edoxaban (DOAC: direct oral anticoagulant) instead of warfarin for antithrombotic therapy during the perioperative period of high-risk gastrointestinal endoscopic procedures
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Post-procedural bleeding rate (soon after registration to 2 months after endoscopic procedures, >= CTCAE v4.0 Grade 3)
Key secondary outcomes	1) Thromboembolism rate (soon after registration to 2 months after endoscopic procedures) 2) All complication rate (soon after registration to 2 months after endoscopic procedures) 3) Post-procedural bleeding rate (soon after registration to 2 months after endoscopic procedures, >= CTCAE v4.0 Grade 1) 4) Length of hospital stay

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Replace warfarin to edoxaban before endoscopic procedures
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Japanese patients taking warfarin or edoxaban to prevent thromboembolism caused by non-valvular atrial fibrillation or recurrence of deep vein thrombus 2) 20 years old or older 3) Performance status (ECOG) of 0 to 2 4) Hb: >=9 g/dl 5) Plt: >=100000 /mm3 6) AST, ALT: <=150 U/l 7) eGFR: >=30 ml/min 8) Written informed consent
Key exclusion criteria	1) Patients with clinical bleeding tendency 2) Patient during the other antithrombotic agent except warfarin or edoxaban 3) Allergy to DOAC 4) Patient during azole antifungal drugs 5) Pregnant or lactation woman 6) Patient with mitral stenosis or replacement of the artificial valve 7) Patient with a history of cardioembolic ischemic stroke 8) Patient with a history of ischemic stroke or TIA 9) Patient with anti-phospholipid antibody syndrome 10) Patient with a history of deep vein thrombosis or pulmonary embolism 11) Patients who are disqualified for the study by physicians 12) Patient with contraindication for edoxaban
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Shuji Middle name Last name Terai
Organization	Niigata University Graduate School of Medical and Dental Sciences
Division name	Division of Gastroenterology and Hepatology
Zip code	951-8510
Address	1-757 Asahimachidori, Chuo-ku, Niigata city
TEL	025-227-2207
Email	terais@med.niigata-u.ac.jp

Public contact
Name of contact person	1st name Junji Middle name Last name Yokoyama
Organization	Niigata University Medical and Dental Hospital
Division name	Division of Endoscopy
Zip code	951-8520
Address	1-754 Asahimachidori, Chuo-ku, Niigata city
TEL	025-223-6161
Homepage URL
Email	yokoyaj@med.niigata-u.ac.jp

Sponsor
Institute	Niigata University Graduate School of Medical and Dental Sciences
Institute
Department

Funding Source
Organization	Niigata University Graduate School of Medical and Dental Sciences
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	Niigata University ethic screening committee
Address	1-757 Asahimachidori, Chuo-ku, Niigata city
Tel	0252272625
Email	https://niigata.bvits.com/rinri/

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	新潟大学医歯学総合病院（新潟県）

Other administrative information
Date of disclosure of the study information	2018 Year 03 Month 08 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	12
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	2017 Year 10 Month 19 Day
Date of IRB	2018 Year 01 Month 22 Day
Anticipated trial start date	2018 Year 04 Month 01 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 02 Month 28 Day
Last modified on	2020 Year 03 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035983

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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