A study to assess the safety of non-vitamin K antagonist oral anticoagulants on high-risk gastrointestinal endoscopic procedures

A study to assess the safety of non-vitamin K antagonist oral anticoagulants on high-risk gastrointestinal endoscopic procedures - NOAC study

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000018284

Enrollment

Registered

2015-07-13

Start date

2015-07-13

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, endoscopic balloon dilation, endoscopic mucosal ablation or percutaneous endoscopic gastrostomy

Interventions

Replacement of warfarin by NOAC before endoscopic procedures

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Taking warfarin or NOAC 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) Clinical bleeding tendency 2) Allergy to NOAC 3) Azole antifungal drugs 4) Pregnant or lactation woman 5) Patients who are disqualified for the study by physicians

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 ContactMasamichi Arao

Osaka International Cancer Institute Department of Gastrointestinal Oncology

arao-ma@mc.pref.osaka.jp06-6945-1181

Outcome results

None listed

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