Patients on Antithrombotics for Colonoscopy

Prospective Collection of Clinical and Laboratory Variables of Patients Receiving Antithrombotics and Requiring Colonoscopy

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.

Study Overview

• Status: Recruiting
• Conditions: Colonoscopy; Antithrombotics

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 Type: Observational
• Enrollment (Anticipated): 6000

Contacts and Locations

• Study Contact: Name: Moe Htet Kyaw, MBBS; Phone Number: 35053476; Email: moehkyaw@cuhk.edu.hk
• Study Contact Backup: Name: Ka Man Kee, MPH; Phone Number: 35053855; Email: carmenkee@cuhk.edu.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Prince of Wales Hospital
    • Contact: Daphne Ng, BA; Phone Number: 35053855; Email: daphneng@cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients receiving antithrombotics at colonoscopy arrangement and undergoing elective colonoscopy

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Antithrombotics; The patients should be on antithrombotics on the day of colonoscopy arrangement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immediate post polypectomy bleeding	Immediate post polypectomy bleeding is defined as bleeding at the time of colonoscopy after polypectomy and requiring endoscopic intervention at the same colonoscopy.	During Colonoscopy
Serious cardiovascular event	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.	Within 6 months.

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Collaborators: Beijing Friendship Hospital
• Investigators: Principal Investigator: Moe Htet Kyaw, MBBS, Chinese University of Hong Kong

Publications and helpful links

General Publications

• 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 record dates

Study Major Dates

• Study Start (Actual): December 8, 2017
• Primary Completion (Anticipated): November 30, 2027
• Study Completion (Anticipated): November 30, 2028

Study Registration Dates

• First Submitted: November 30, 2017
• First Submitted That Met QC Criteria: November 30, 2017
• First Posted (Actual): December 6, 2017

Study Record Updates

• Last Update Posted (Actual): January 18, 2022
• Last Update Submitted That Met QC Criteria: January 14, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: Colon Registry

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No