Patients on Antithrombotics for Colonoscopy
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|ClinicalTrials.gov Identifier: NCT03363061|
Recruitment Status : Recruiting
First Posted : December 6, 2017
Last Update Posted : March 1, 2018
|Condition or disease|
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|
|Estimated Enrollment :||6000 participants|
|Official Title:||Prospective Collection of Clinical and Laboratory Variables of Patients Receiving Antithrombotics and Requiring Colonoscopy|
|Actual Study Start Date :||December 8, 2017|
|Estimated Primary Completion Date :||November 30, 2027|
|Estimated Study Completion Date :||November 30, 2028|
The patients should be on antithrombotics on the day of colonoscopy arrangement
- 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.
- 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.
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
|Contact: Moe Htet Kyaw, MBBSfirstname.lastname@example.org|
|Contact: Ka Man Kee, MPHemail@example.com|
|Prince of Wales Hospital||Recruiting|
|Hong Kong, Hong Kong|
|Contact: Daphne Ng, BA 35053855 firstname.lastname@example.org|
|Principal Investigator:||Moe Htet Kyaw, MBBS||Chinese University of Hong Kong|