Comparing Continuing or Stopping Aspirin in Adults at Moderate Cardiovascular Risk Undergoing Colonoscopy or Polypectomy A Randomized Placebo-Controlled Study
Led by Chinese University of Hong Kong · Updated on 2026-03-18
2514
Participants Needed
1
Research Sites
52 weeks
Total Duration
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
Research Team
J
James Yun Wong Lau, MD
C
Cecilia Chan, PhD
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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
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
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
Endoscopy in patients on antiplatelet or anticoagulant therapy: British Society of Gastroenterology (BSG) and European Society of Gastrointestinal Endoscopy (ESGE) guideline update.
Aspirin for cardiovascular disease prevention among adults in the United States: Trends, prevalence, and participant characteristics associated with use.
Ellen Boakye, S M Iftekhar Uddin, Olufunmilayo H Obisesan...
Impact 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.
Collaborative meta-analysis of randomised trials of antiplatelet therapy for prevention of death, myocardial infarction, and stroke in high risk patients.