RecruitingPhase 3NCT07052799

Aspirin Continuation or Interruption in Patients at Moderate Risk for Cardiovascular Events Undergoing Colonoscopy and/or Polypectomy

Aspirin Continuation or Interruption in Patients at Moderate Risk for Cardiovascular Events Undergoing Colonoscopy and/or Polypectomy; a Placebo-controlled Trial


Sponsor

Chinese University of Hong Kong

Enrollment

2,514 participants

Start Date

Feb 10, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

One in 4 adults between 50 and 80 reports taking regular aspirin. The prevalence of aspirin uses increases with age as well as co-morbid vascular diseases. Patients with cardiovascular diseases are at risk of developing colorectal neoplasms. In patients undergoing screening colonoscopy, interruption of aspirin is believed to be associated with increased cardiovascular events. Continuation of aspirin can however be associated with an increased risk of post-polypectomy bleeding. International guidelines on periendoscopy management recommend the continuation of aspirin based on evidence from cohort studies, mostly retrospective, suggesting that the rate of bleeding is low. Cardiovascular complications from aspirin interruption can lead to disabilities and occasional deaths. The cardiovascular risks following aspirin continuation or interruption in endoscopy have not been well studied. There has been no randomized study to compare either strategy. Endoscopists are divided on their opinion on whether to stop or to continue aspirin. The proposed large randomized controlled trial (RCT) is powered to detect small differences in both outcomes. Findings from this RCT will address this important question and inform our clinical practice.


Eligibility

Min Age: 18 Years

Inclusion Criteria1

  • patients receiving aspirin (80mg daily or more) for secondary prevention against cardiovascular diseases who require elective colonoscopy for colorectal cancer screening.

Exclusion Criteria6

  • 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

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Interventions

DRUGAspirin 80mg

8-day (-5, +3) supply of aspirin 80mg before and after colonoscopy

DRUGPlacebo Oral Tablet

8-day (-5, +3) supply of placebo before and after colonoscopy


Locations(1)

Prince of Wales Hospital

Hong Kong, Hong Kong

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NCT07052799


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