NCT03363061

Brief Summary

The use of antithrombotics (antiplatelet agents and anticoagulants) is increasing with an aging global population.Management of antithrombotics in patients undergoing invasive procedures including gastrointestinal endoscopy remains a challenge. Management approach includes taking a precarious balance between the risk of thromboembolism after interruption of antithrombotics and risk of bleeding with the continuation of antithrombotics. Colonoscopy remains one of the commonest endoscopic procedures performed. The optimal management strategy of different antithrombotics during colonoscopy remains unclear.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,000

participants targeted

Target at P75+ for all trials

Timeline
32mo left

Started Dec 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress77%
Dec 2017Nov 2028

First Submitted

Initial submission to the registry

November 30, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 6, 2017

Completed
2 days until next milestone

Study Start

First participant enrolled

December 8, 2017

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2028

Last Updated

January 18, 2022

Status Verified

January 1, 2022

Enrollment Period

10 years

First QC Date

November 30, 2017

Last Update Submit

January 14, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Delayed post polypectomy bleeding

    Delayed post polypectomy bleeding is defined as blood per rectum occurring after colonoscope has been retracted from the anus to 30 days after the procedure requiring hospitalization or treatment.

    Within 30 days

Secondary Outcomes (2)

  • Immediate post polypectomy bleeding

    During Colonoscopy

  • Serious cardiovascular event

    Within 6 months.

Study Arms (1)

Antithrombotics

The patients should be on antithrombotics on the day of colonoscopy arrangement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients receiving antithrombotics at colonoscopy arrangement and undergoing elective colonoscopy

You may qualify if:

  • Patients must be over 18 years of age
  • Patients undergoing elective colonoscopy for any indication, who are receiving antithrombotics
  • Informed consent is obtained

You may not qualify if:

  • Patients under 18 years of age
  • Inability to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

RECRUITING

Related Publications (1)

  • Jiang W, Suen BY, Ho HT, Ching JYL, Chan FKL, Mak JWY. Impact of Physicians' and Patients' Compliance on Outcomes of Colonoscopic Polypectomy With Anti-Thrombotic Therapy. Clin Gastroenterol Hepatol. 2021 Dec;19(12):2559-2566.e1. doi: 10.1016/j.cgh.2020.09.019. Epub 2020 Sep 12.

Study Officials

  • Moe Htet Kyaw, MBBS

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Moe Htet Kyaw, MBBS

CONTACT

Ka Man Kee, MPH

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

November 30, 2017

First Posted

December 6, 2017

Study Start

December 8, 2017

Primary Completion (Estimated)

November 30, 2027

Study Completion (Estimated)

November 30, 2028

Last Updated

January 18, 2022

Record last verified: 2022-01

Locations