Edoxaban study

JRCT ID: jRCTs031180190

Registered date:06/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: All diseases that require high-risk gastrointestinal endoscopic procedures such as endoscopic polype
• Date of first enrollment: 05/10/2018
• Target sample size: 40
• Study type: Interventional
• Intervention(s): Replace warfarin to Edoxaban before endoscopic procedures

Outcome(s)

• Primary Outcome: Post-procedural bleeding rate (soon after registration to 2 months after endoscopic procedures, >= CTCAE v5.0 Grade 3)

Secondary Outcome

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 v5.0 Grade 1)
4) Length of hospital stay

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Terai Shuji
• Source(s) of Monetary Support: DAIICHI SANKYO COMPANY, LIMITED
• Secondary ID(s): UMIN000031523