A study on efficacy and safety of Edoxaban on high-risk gastrointestinal endoscopic procedures

A study on efficacy and safety of Edoxaban on high-risk gastrointestinal endoscopic procedures - Edoxaban study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000031523

Enrollment

Registered

2018-03-08

Start date

2018-04-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

All diseases that require high-risk gastrointestinal endoscopic procedures such as endoscopic polypectomy, endoscopic mucosal resection, endoscopic submucosal dissection or endoscopic mucosal ablation

Interventions

Replace warfarin to edoxaban before endoscopic procedures

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Post-procedural bleeding rate (soon after registration to 2 months after endoscopic procedures, >= CTCAE v4.0 Grade 3)	—

Secondary

Measure	Time frame
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	—

Countries

Japan

Contacts

Public ContactJunji Yokoyama

Niigata University Medical and Dental Hospital Division of Endoscopy

yokoyaj@med.niigata-u.ac.jp025-223-6161

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026