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Patients on Antithrombotics for Colonoscopy

Sponsor
Chinese University of Hong Kong (Other)
Overall Status
Recruiting
CT.gov ID
NCT03363061
Collaborator
Beijing Friendship Hospital (Other)
6,000
Enrollment
1
Location
131.7
Anticipated Duration (Months)
45.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The use of antithrombotics (antiplatelet agents and anticoagulants) is increasing with an aging global population. Cardiovascular disease is a leading cause of death worldwide. Clinical Practice Research Datalink (CPRD) GOLD database suggests that over 915 000 people in the UK have suffered a myocardial infarction and over 1.3 million are living with angina in 2013. Two percent of people in developed countries are on long-term anticoagulation and up to 10% in the elderly 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. The availability of new antithrombotic agents adds to the complexity of antithrombotic management during endoscopy. Warfarin has been the only oral anticoagulant available until the introduction of direct oral anticoagulants (DOACs). Newer antiplatelet agents (prasugrel and ticagrelor, vorapaxar) are becoming more commonly used for the treatment of the acute coronary syndrome.

    There remain gaps in the management approach of patients receiving antithrombotics and requiring endoscopy. It is still uncertain of the actual bleeding risk associated with antithrombotic use during endoscopy. Colonoscopy remains one of the commonest endoscopic procedures performed. It is the gold standard for direct evaluation of the colon for patients with the suspected colonic disease. It is also used as a screening test for prevention of colorectal cancer by colonoscopic polypectomy of precancerous polyps.The optimal management strategy of different antithrombotics during colonoscopy remains unclear.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    6000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Prospective Collection of Clinical and Laboratory Variables of Patients Receiving Antithrombotics and Requiring Colonoscopy
    Actual Study Start Date :
    Dec 8, 2017
    Anticipated Primary Completion Date :
    Nov 30, 2027
    Anticipated Study Completion Date :
    Nov 30, 2028

    Arms and Interventions

    Arm Intervention/Treatment
    Antithrombotics

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

    Outcome Measures

    Primary Outcome Measures

    1. Delayed post polypectomy bleeding [Within 30 days]

      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.

    Secondary Outcome Measures

    1. Immediate post polypectomy bleeding [During Colonoscopy]

      Immediate post polypectomy bleeding is defined as bleeding at the time of colonoscopy after polypectomy and requiring endoscopic intervention at the same colonoscopy.

    2. Serious cardiovascular event [Within 6 months.]

      Serious cardiovascular event is defined as nonfatal myocardial infarction, nonfatal stroke, or death from a vascular cause as defined by Anti-Platelet Trialists Collaboration criteria within 6 months.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients must be over 18 years of age

    • Patients undergoing elective colonoscopy for any indication, who are receiving antithrombotics

    • Informed consent is obtained

    Exclusion Criteria:

    • Patients under 18 years of age

    • Inability to give informed consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Prince of Wales Hospital Hong Kong Hong Kong

    Sponsors and Collaborators

    • Chinese University of Hong Kong
    • Beijing Friendship Hospital

    Investigators

    • Principal Investigator: Moe Htet Kyaw, MBBS, Chinese University of Hong Kong

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mak Wing Yan, Associate professor, Chinese University of Hong Kong
    ClinicalTrials.gov Identifier:
    NCT03363061
    Other Study ID Numbers:
    • Colon Registry
    First Posted:
    Dec 6, 2017
    Last Update Posted:
    Jan 18, 2022
    Last Verified:
    Jan 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jan 18, 2022