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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Terminated |
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 | 2020/03/02 |
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 |
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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 |
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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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 40 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |