UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031523 |
|---|---|
| Receipt number | 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 | 2020/03/02 09:23:29 |
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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 | 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
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
yokoyaj@med.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University Graduate School of Medical and Dental Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035983
