Colorectal polypectomy and endoscopic mucosal resection: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Update 2024.
Monika Ferlitsch, Cesare Hassan, Raf Bisschops...
https://pubmed.ncbi.nlm.nih.gov/38670139Actively Recruiting
Phase 3
Age: 18Years +
All Genders
ID07052799
Aspirin Continuation or Interruption in Patients at Moderate Risk for Cardiovascular Events Undergoing Colonoscopy and/or Polypectomy; a Placebo-controlled Trial
Led by Chinese University of Hong Kong · Updated on 2026-03-18
2514
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of continuing versus interrupting aspirin in adults who take aspirin for heart disease and are undergoing colonoscopy or polypectomy. This trial aims to compare cardiovascular events and bleeding risks related to either continuing aspirin or stopping it before the procedure. Previous studies were mainly observational, and there has been no randomized trial to confirm the best approach. Participants will be randomly assigned to receive either aspirin 80mg or a placebo for about 8 days before and after their colonoscopy. This large, phase 3 trial uses a placebo-controlled and quadruple-blind design to carefully assess outcomes. The study will last from February 2026 to December 2031, with treatments given around the time of colonoscopy. During the trial, participants will be monitored for cardiovascular events and major bleeding within 30 days after the procedure. Researchers will track mortality and other health outcomes during this period. The study aims to provide clear evidence on whether continuing aspirin affects bleeding risk or heart complications, helping guide future clinical care.
CONDITIONS
Brief Title
Aspirin Continuation or Interruption in Patients at Moderate Risk for Cardiovascular Events Undergoing Colonoscopy and/or Polypectomy
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients taking aspirin 80mg daily or more for secondary prevention of cardiovascular diseases
- Patients scheduled for elective colonoscopy for colorectal cancer screening
You will not qualify if you...
- Patients who had a coronary stent within the past 6 months
- Patients with a cardiovascular event within the past 3 months
- Patients currently using anticoagulants like warfarin or NOACs or other antiplatelet drugs (P2Y12 receptor antagonists)
- Patients with bleeding disorders such as hemophilia, von Willebrand's disease, or liver cirrhosis-related coagulopathy
- Patients with terminal cancer or serious medical illnesses
- Patients unable or unwilling to provide consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Approximately 11 days (8 days with a window of -5 to +3 days around colonoscopy)
Participants receive either aspirin 80mg or placebo for approximately 8 days before and after their colonoscopy procedure.
1 baseline visit and 1 procedure visit
Follow-up
Duration - 30 days
Participants are monitored for cardiovascular events, bleeding, and other outcomes for 30 days after colonoscopy.
Follow-up visits as needed within 30 days post-procedure
Trial Site Locations
Total: 1 location
1
Prince of Wales Hospital
Hong Kong, Hong Kong
Actively Recruiting
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Research Team
J
James Yun Wong Lau, MD
C
Cecilia Chan, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
Collaborative meta-analysis of randomised trials of antiplatelet therapy for prevention of death, myocardial infarction, and stroke in high risk patients.
Antithrombotic Trialists' Collaboration
https://pubmed.ncbi.nlm.nih.gov/11786451Periprocedural management of aspirin during colonoscopy: a survey of practice patterns in the United States.
Richard Robbins, Chenlu Tian, Amit Singal...
https://pubmed.ncbi.nlm.nih.gov/25975531Aspirin in patients undergoing noncardiac surgery.
P J Devereaux, Marko Mrkobrada, Daniel I Sessler...
https://pubmed.ncbi.nlm.nih.gov/24679062Impact of preoperative maintenance or interruption of aspirin on thrombotic and bleeding events after elective non-cardiac surgery: the multicentre, randomized, blinded, placebo-controlled, STRATAGEM trial.
J Mantz, C M Samama, F Tubach...
https://pubmed.ncbi.nlm.nih.gov/21873632To continue or discontinue aspirin in the perioperative period: a randomized, controlled clinical trial.
A Oscarsson, A Gupta, M Fredrikson...
https://pubmed.ncbi.nlm.nih.gov/20150346Risk of colonoscopic post-polypectomy bleeding in patients on single antiplatelet therapy: systematic review with meta-analysis.
Marco Valvano, Stefano Fabiani, Marco Magistroni...
https://pubmed.ncbi.nlm.nih.gov/35028736Post-polypectomy bleeding in the English National Health Service Bowel Cancer Screening Programme.
Edmund Derbyshire, Pali Hungin, Claire Nickerson...
https://pubmed.ncbi.nlm.nih.gov/28753697The national colonoscopy audit: a nationwide assessment of the quality and safety of colonoscopy in the UK.
Daniel R Gavin, Roland M Valori, John T Anderson...
https://pubmed.ncbi.nlm.nih.gov/22661458Endoscopy in patients on antiplatelet or anticoagulant therapy: British Society of Gastroenterology (BSG) and European Society of Gastrointestinal Endoscopy (ESGE) guideline update.
Andrew M Veitch, Franco Radaelli, Raza Alikhan...
https://pubmed.ncbi.nlm.nih.gov/34362780