Patients on Antithrombotics for Colonoscopy

NCT ID: NCT03363061

Last Updated: 2022-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

6000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-08

Study Completion Date

2028-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Antithrombotics Colonoscopy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Antithrombotics

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Friendship Hospital

OTHER

Sponsor Role collaborator

Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Mak Wing Yan

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Moe Htet Kyaw, MBBS

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

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Prince of Wales Hospital

Hong Kong, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Moe Htet Kyaw, MBBS

Role: CONTACT

Ka Man Kee, MPH

Role: CONTACT

Facility Contacts

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Daphne Ng, BA

Role: primary

References

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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.

Reference Type DERIVED
PMID: 32931958 (View on PubMed)

Other Identifiers

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Colon Registry

Identifier Type: -

Identifier Source: org_study_id

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