Edoxaban study

Not Applicable

• Conditions: All diseases that require high-risk gastrointestinal endoscopic procedures such as endoscopic polype

• Registration Number: JPRN-jRCTs031180190
• Lead Sponsor: Terai Shuji

Brief Summary

The incidence rate of thrombosis and embolism associated with the replacement of warfarin to edoxaban before surgery and the withdrawal of edoxaban for 1 ~ 2 days from the day of surgery was 0%. In addition, the incidence of postprocedural bleeding was 14.3%, almost the same as the previous occurrence rate by heparin bridge therapy. On the other hand, the length of hospitalization was 8.7 days, which was significantly shorter than heparin bridge therapy.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-06
• Study Completion: 2021-10-14
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

1) Japanese patients taking Warfarin or Edoxban to prevent thromboembolism caused by non-valvula 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: >= 100,000 /mm3
6) AST,ALT: <= 150 U/l
7) eGFR: >= 30 ml/min
8) Written informed consent

Exclusion Criteria

1) Patients with clinical bleeding tendency
2) Patients during the other antithrombotic agent except warfarin or
Edoxaban
3) Allergy to DOAC
4) Patients during azole antifungal drugs
5) Pregnant or lactation woman
6) Patients with mitral stenosis or replacement of the artificial valve
7) Patients with a history of cardiogenic ischemic stroke
8) Patients with a history of ischemic stroke or TIA
9) Patients with mitral valve regurgitation or aortic valvular disease
10) Patients with anti-phospholipid antibody syndrome
11) Patients with a history of deep vein thrombosis or pulmonary embolism
12) Patients who are disqualified for the study by physicians
13) Patients 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 v5.0 Grade 3)

Secondary Outcome Measures

Name	Time	Method
1) thromboembolism rate (soon after registration to 2 months after endoscopic procedures)<br>2) All complication rate (soon after registration to 2 months after endoscopic procedures)<br>3) Post-procedural bleeding rate (soon after registration to 2 months after endoscopic procedures, >= CTCAE v5.0 Grade 1)<br>4) Length of hospital stay