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Patients on Antithrombotics for Colonoscopy

This study is not yet open for participant recruitment.
Verified December 2017 by Moe Htet Kyaw, Chinese University of Hong Kong
Sponsor:
ClinicalTrials.gov Identifier:
NCT03363061
First Posted: December 6, 2017
Last Update Posted: December 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Moe Htet Kyaw, Chinese University of Hong Kong
  Purpose
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
Antithrombotics Colonoscopy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Collection of Clinical and Laboratory Variables of Patients Receiving Antithrombotics and Requiring Colonoscopy

Resource links provided by NLM:


Further study details as provided by Moe Htet Kyaw, Chinese University of Hong Kong:

Primary Outcome Measures:
  • Delayed post polypectomy bleeding [ Time Frame: 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    Delayed post polypectomy bleeding is defined as blood per rectum occurring after colonoscope has been retracted from the anus to 30 days after the procedure requiring hospitalization or treatment.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:
  • Immediate post polypectomy bleeding [ Time Frame: 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.

  • Serious cardiovascular event [ Time Frame: 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.


Estimated Enrollment: 6000
Anticipated Study Start Date: December 8, 2017
Estimated Study Completion Date: November 30, 2028
Estimated Primary Completion Date: November 30, 2027 (Final data collection date for primary outcome measure)
Groups/Cohorts
Antithrombotics
The patients should be on antithrombotics on the day of colonoscopy arrangement

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients receiving antithrombotics at colonoscopy arrangement and undergoing elective colonoscopy
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03363061


Contacts
Contact: Moe Htet Kyaw, MBBS 35053476 moehkyaw@cuhk.edu.hk
Contact: Ka Man Kee, MPH 35053855 carmenkee@cuhk.edu.hk

Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Moe Htet Kyaw, MBBS Chinese University of Hong Kong
  More Information

Responsible Party: Moe Htet Kyaw, Research Assistant Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT03363061     History of Changes
Other Study ID Numbers: Colon Registry
First Submitted: November 30, 2017
First Posted: December 6, 2017
Last Update Posted: December 8, 2017
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No