About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
patients receiving aspirin (80mg daily or more) for secondary prevention against cardiovascular diseases who require elective colonoscopy for colorectal cancer screening.
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Aspirin 80mg
Drug8-day (-5, +3) supply of aspirin 80mg before and after colonoscopy
Placebo Oral Tablet
Drug8-day (-5, +3) supply of placebo before and after colonoscopy
Treatment groups
Trial outcomes
Primary outcomes
cardiovascular events
cardiovascular events defined according to the Antithrombotic Trialists' criteria (nonfatal myocardial infarction, nonfatal stroke, or death from a vascular cause)
Secondary outcomes
major bleeding during colonoscopy
major bleeding during colonoscopy defined as bleeding requiring transfusion, angiographic embolization, or surgery. PPB is defined by bleeding after withdrawal of the colonoscope
mortality by all causes
mortality by all causes
Sponsors and contacts
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