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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorChinese University of Hong Kong

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Aspirin 80mg

    Drug

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

  • Placebo Oral Tablet

    Drug

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

Treatment groups

2,514 Participants
are divided into 2 treatment groups
Group A: aspirinActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

cardiovascular events

cardiovascular events defined according to the Antithrombotic Trialists' criteria (nonfatal myocardial infarction, nonfatal stroke, or death from a vascular cause)

Time frame
30 days

Secondary outcomes

1

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

Time frame
30 days
2

mortality by all causes

mortality by all causes

Time frame
30 days

Other outcomes

Sponsors and contacts

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