Timing of Resumption of Direct Oral Anticoagulants Following Polypectomy

April 27, 2026 updated by: LEUNG Wai Keung, The University of Hong Kong

Timing of Resumption of Direct Oral Anticoagulants Following Colonoscopy Polypectomy: a Prospective Randomized Non-inferiority Trial

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):

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Eligible patients will only be randomly assigned to two different arms after total colonoscopy and polypectomy. The first group will recommence DOACs on Day 2 as recommended by current guideline (Late Resumption), while the second group will resume DOACs on the same day of the procedure (Early Resumption).

All procedures will be conducted by experienced endoscopists with more than 5-year of colonoscopy experiences All polyps detected will be removed, except for very large lesion that would require endoscopic submucosal dissection in which another session will be scheduled. These patients will not be enrolled in this study if polyp removal is not performed. A standard protocol for polypectomy will be adopted in this study. Polyps smaller than 3mm will be removed by cold biopsy forceps or cold snare polypectomy, while those between 3mm and 10mm will be removed with a cold snare. Polyps larger than 10mm will be removed by cold snare if feasible, but hot snare is also allowed for these lesions. Prophylactic endoclip would be applied to polyp >=10mm in diameter; and can also be applied to smaller polyp subject to endoscopist's discretion as the benefits of prophylactic clipping is still uncertain in patients on DOACs. Photo-documentation of all polyps and their polypectomy sites would be required. Immediate bleeding during polypectomy, as defined as active spurting or continuous oozing despite observation for more than 1 minute, should be dealt with as usual practice with adrenaline injection, endoclips and thermocoagulation. These patients will be excluded from this study.

All patients will be followed up from the day of colonoscopy (Day 0) to Day 30. The patients (and their carers) will be given clear written and verbal instruction on the exact date of resumption of DOAC according to the group assigned (Day 0 or Day 2). Patients will also be given a list of warning symptoms to observe including bleeding (per-rectal bleeding or haematochezia), or thrombo-embolic events (stroke, chest pain and limb weakness or numbness, etc) for reference. They will be given a contact number for direct contact to the research team (during office hour) or are given advice to attend to the nearest emergency department in the presence of these warning symptoms. Patients will be contacted by research staff on day 2 and day 7 by phone to ensure their compliance with DOACs resumption schedule and any potential adverse event. A follow up visit at day 30 will be arranged for histological reports as well as any potential adverse events. All unscheduled medical attendance and hospitalization will be recorded up to Day 30. For patients who default on day 30 follow up, phone contact will be made, and their medical record will be searched through the electronic medical system of the Hospital Authority, which covers all public hospitals of Hong Kong, to look for any unscheduled emergency attendance and hospitalization

Regular progress meeting will be conducted every 6 months to discuss patient's enrolment and any adverse events. As the investigators are not blinded to the treatment allocation, an independent safety committee including cardiologist, neurologist and endoscopist (not involved in this study) will be formed to study all adverse events and its potential association with the assigned group. The safety committee will meet every 12 months unless requested by the study team due to emerging safety data.

A planned interim analysis will also be conducted after enrolling the first 100 patients to look for any safety signals or concerns, particularly if the bleeding risk in the early resumption group turns out to be much higher than the late resumption group. After deliberation by the safety committee, early termination of trial may be triggered if significant and persistent difference in outcomes between two groups occurs to an extent that patient outcome is affected.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
194

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Queen Mary Hospital, The University of Hong Kong
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

- 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Late Resumption
The first group will recommence DOACs on Day 2 as recommended by current guideline (Late Resumption)
Other: Time for resumption of DOAC
Time for resumption of DOAC
Experimental: Early Resumption
The second group will resume DOACs on the same day of the procedure (Early Resumption).
Other: Time for resumption of DOAC
Time for resumption of DOAC

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Post-polypectomy bleeding
Time Frame: within 30 days after polypectomy during colonoscopy
both major and clinically relevant non-major bleeding (CRNMB)
within 30 days after polypectomy during colonoscopy

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Occurrence of thromboembolic events within 30 days
Time Frame: within 30 days after polypectomy during colonoscopy
Occurrence of thromboembolic events within 30 days
within 30 days after polypectomy during colonoscopy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Hong Kong

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Wai Keung Leung, The University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 3, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 25, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 1, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Colonoscopy_antithromboticv3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings