Continuing versus stopping daily aspirin before colonoscopy with possible polyp removal
Aspirin Continuation or Interruption in Patients at Moderate Risk for Cardiovascular Events Undergoing Colonoscopy and/or Polypectomy; a Placebo-controlled Trial
PHASE3 · Chinese University of Hong Kong · NCT07052799
This trial tests whether people taking daily low‑dose aspirin to prevent heart problems should keep taking aspirin or stop it before an elective colonoscopy with possible polyp removal to balance heart and bleeding risks.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 2514 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chinese University of Hong Kong (other) |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT07052799 on ClinicalTrials.gov |
What this trial studies
This is a randomized, phase 3 trial comparing continuation of daily low‑dose aspirin (80 mg) versus interruption (placebo) in patients who take aspirin for secondary cardiovascular prevention and are undergoing elective colonoscopy with potential polypectomy. Participants are randomly assigned to continue aspirin or receive placebo around the time of the procedure, and outcomes include post‑polypectomy bleeding and cardiovascular events. The trial focuses on short‑term periendoscopic safety and clinically important bleeding and thrombotic endpoints. Results aim to provide randomized evidence to inform guideline recommendations about peri‑colonoscopy aspirin management.
Who should consider this trial
Good fit: Ideal candidates are people taking daily aspirin (≥80 mg) for secondary prevention of cardiovascular disease who need an elective colonoscopy and possible polypectomy and who do not have recent stents, recent cardiac events, use of anticoagulants or other antiplatelet drugs, bleeding disorders, or terminal illness.
Not a fit: Patients with a coronary stent within 6 months, a cardiovascular event within 3 months, concurrent anticoagulant or P2Y12 inhibitor use, active bleeding disorders, or terminal illnesses are excluded and would not benefit from participating.
Why it matters
Potential benefit: If successful, the trial could identify a safer approach that reduces heart complications from stopping aspirin without causing an unacceptable increase in bleeding after polypectomy.
How similar studies have performed: Most existing evidence comes from large retrospective cohort series suggesting low bleeding rates with aspirin continuation but there has been no prior randomized trial directly comparing continuation versus interruption in this setting.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients receiving aspirin (80mg daily or more) for secondary prevention against cardiovascular diseases who require elective colonoscopy for colorectal cancer screening. Exclusion Criteria: * patients who received a coronary stent of any type within 6 months * patients who had a cardiovascular event within 3 months * patients who had concurrent use of anticoagulants (warfarin or NOAC) or other antiplatelet drugs (P2Y12 receptor antagonists) * patient with bleeding diathesis e.g., hemophilia, von Willebrand's disease or coagulopathy from liver cirrhosis * patient with terminal malignancies or medical illnesses. * patient who is unable or refuse to give consents
Where this trial is running
Hong Kong
- Prince of Wales Hospital — Hong Kong, Hong Kong (RECRUITING)
Study contacts
- Principal investigator: James Yun Wong Lau, MD — Chinese University of Hong Kong
- Study coordinator: James Yun Wong Lau, MD
- Email: laujyw@surgery.cuhk.edu.hk
- Phone: +85235051445
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Myocardial Infarction, Cardiovascular Events, Post Polypectomy Bleeding in Antiplatelet Patients, Aspirin continuation or interruption, polypectomy, cardiovascular events