Timing of Resumption of Direct Oral Anticoagulants Following Polypectomy

NCT06482333 | Recruiting DMC

• 1 other identifier: Colonoscopy_antithromboticv3
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this prospective randomized non-inferiority trial is to compare two different resumption time of Direct Oral Anticoagulants (DOACs) after colonoscopic polypectomy. We hypothesize that early resumption of DOACs after colonoscopy and polypectomy is associated with comparable post-polypectomy bleeding rate to those with delayed resumption. This study aims to compare the post-polypectomy bleeding risk of two different timing of resuming DOACs (Day 0 vs Day 2):

Conditions

Postpolypectomy Bleeding

Keywords

Postpolypectomy bleeding,; DOAC; Colonoscopy

Outcome Measures

Primary Outcomes (1)

• Post-polypectomy bleeding

  both major and clinically relevant non-major bleeding (CRNMB)

  within 30 days after polypectomy during colonoscopy

Secondary Outcomes (1)

• Occurrence of thromboembolic events within 30 days

  within 30 days after polypectomy during colonoscopy

Study Arms (2)

Late Resumption

ACTIVE COMPARATOR

The first group will recommence DOACs on Day 2 as recommended by current guideline (Late Resumption)

Other: Time for resumption of DOAC

Early Resumption

EXPERIMENTAL

The second group will resume DOACs on the same day of the procedure (Early Resumption).

Other: Time for resumption of DOAC

Interventions

Time for resumption of DOAC OTHER

Time for resumption of DOAC

Early Resumption; Late Resumption

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- All adult patients who are taking DOACs and schedule for elective colonoscopy are potentially eligible. We only included patients who had complete colonoscopy and with polypectomy performed.

You may not qualify if:

• Previous resection of any colonic segments,
• Inflammatory bowel disease or polyposis syndrome
• Patient with large polyp required advanced procedure e.g. endoscopic submucosal dissection (ESD) to remove
• Patients who develop immediate post-polypectomy bleeding during the procedure and requiring haemostasis will also be excluded
• Patient without polypectomy
• Patient without complete colonoscopy done

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Queen Mary Hospital, the University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Interventions

Time

Intervention Hierarchy (Ancestors)

Physical Phenomena

Study Officials

• Wai Keung Leung

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wai Keung Leung

CONTACT

+852 22553348; waikleung@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: July 1, 2024
• Study Start: October 3, 2024
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)