A study on efficacy and safety of Edoxaban on high-risk gastrointestinal endoscopic procedures
Not Applicable
- Conditions
- All diseases that require high-risk gastrointestinal endoscopic procedures such as endoscopic polypectomy, endoscopic mucosal resection, endoscopic submucosal dissection or endoscopic mucosal ablation
- Registration Number
- JPRN-UMIN000031523
- Lead Sponsor
- iigata University Graduate School of Medical and Dental Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Post-procedural bleeding rate (soon after registration to 2 months after endoscopic procedures, >= CTCAE v4.0 Grade 3)
- Secondary Outcome Measures
Name Time Method 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