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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000031523
Receipt No. R000035983
Scientific Title A study on efficacy and safety of Edoxaban on high-risk gastrointestinal endoscopic procedures
Date of disclosure of the study information 2018/03/08
Last modified on 2018/12/08

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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
Middle name
Last name Shuji Terai
Organization Niigata University Graduate School of Medical and Dental Sciences
Division name Division of Gastroenterology and Hepatology
Zip code
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
Middle name
Last name Junji Yokoyama
Organization Niigata University Medical and Dental Hospital
Division name Division of Endoscopy
Zip code
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
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 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
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 Enrolling by invitation
Date of protocol fixation
2017 Year 10 Month 19 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 01 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
2018 Year 02 Month 28 Day
Last modified on
2018 Year 12 Month 08 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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