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

NCT07052799 | Recruiting Phase 3 DMC

• 1 other identifier: Aspirin Colon Study
• Study Type: interventional
• Target: 2,514
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiovascular Events; Myocardial Infarction (MI); Post Polypectomy Bleeding in Antiplatelet Patients

Keywords

Aspirin continuation or interruption; polypectomy; cardiovascular events

Outcome Measures

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)

  30 days

Secondary Outcomes (2)

• major bleeding during colonoscopy

  30 days

• mortality by all causes

  30 days

Study Arms (2)

aspirin

ACTIVE COMPARATOR

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

Drug: Aspirin 80mg

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo Oral Tablet

Interventions

Aspirin 80mg DRUG

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

aspirin

Placebo Oral Tablet DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

RECRUITING

Related Publications (11)

• Ferlitsch M, Hassan C, Bisschops R, Bhandari P, Dinis-Ribeiro M, Risio M, Paspatis GA, Moss A, Libanio D, Lorenzo-Zuniga V, Voiosu AM, Rutter MD, Pellise M, Moons LMG, Probst A, Awadie H, Amato A, Takeuchi Y, Repici A, Rahmi G, Koecklin HU, Albeniz E, Rockenbauer LM, Waldmann E, Messmann H, Triantafyllou K, Jover R, Gralnek IM, Dekker E, Bourke MJ. Colorectal polypectomy and endoscopic mucosal resection: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Update 2024. Endoscopy. 2024 Jul;56(7):516-545. doi: 10.1055/a-2304-3219. Epub 2024 Apr 26.

  PMID: 38670139 RESULT

• Antithrombotic Trialists' Collaboration. Collaborative meta-analysis of randomised trials of antiplatelet therapy for prevention of death, myocardial infarction, and stroke in high risk patients. BMJ. 2002 Jan 12;324(7329):71-86. doi: 10.1136/bmj.324.7329.71.

  PMID: 11786451 RESULT

• Robbins R, Tian C, Singal A, Agrawal D. Periprocedural management of aspirin during colonoscopy: a survey of practice patterns in the United States. Gastrointest Endosc. 2015 Nov;82(5):895-900. doi: 10.1016/j.gie.2015.03.1976. Epub 2015 May 12.

  PMID: 25975531 RESULT

• Devereaux PJ, Mrkobrada M, Sessler DI, Leslie K, Alonso-Coello P, Kurz A, Villar JC, Sigamani A, Biccard BM, Meyhoff CS, Parlow JL, Guyatt G, Robinson A, Garg AX, Rodseth RN, Botto F, Lurati Buse G, Xavier D, Chan MT, Tiboni M, Cook D, Kumar PA, Forget P, Malaga G, Fleischmann E, Amir M, Eikelboom J, Mizera R, Torres D, Wang CY, VanHelder T, Paniagua P, Berwanger O, Srinathan S, Graham M, Pasin L, Le Manach Y, Gao P, Pogue J, Whitlock R, Lamy A, Kearon C, Baigent C, Chow C, Pettit S, Chrolavicius S, Yusuf S; POISE-2 Investigators. Aspirin in patients undergoing noncardiac surgery. N Engl J Med. 2014 Apr 17;370(16):1494-503. doi: 10.1056/NEJMoa1401105. Epub 2014 Mar 31.

  PMID: 24679062 RESULT

• Mantz J, Samama CM, Tubach F, Devereaux PJ, Collet JP, Albaladejo P, Cholley B, Nizard R, Barre J, Piriou V, Poirier N, Mignon A, Schlumberger S, Longrois D, Aubrun F, Farese ME, Ravaud P, Steg PG; Stratagem Study Group. 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. Br J Anaesth. 2011 Dec;107(6):899-910. doi: 10.1093/bja/aer274. Epub 2011 Aug 27.

  PMID: 21873632 RESULT

• Oscarsson A, Gupta A, Fredrikson M, Jarhult J, Nystrom M, Pettersson E, Darvish B, Krook H, Swahn E, Eintrei C. To continue or discontinue aspirin in the perioperative period: a randomized, controlled clinical trial. Br J Anaesth. 2010 Mar;104(3):305-12. doi: 10.1093/bja/aeq003.

  PMID: 20150346 RESULT

• Valvano M, Fabiani S, Magistroni M, Mancusi A, Longo S, Stefanelli G, Vernia F, Viscido A, Romano S, Latella G. Risk of colonoscopic post-polypectomy bleeding in patients on single antiplatelet therapy: systematic review with meta-analysis. Surg Endosc. 2022 Apr;36(4):2258-2270. doi: 10.1007/s00464-021-08975-0. Epub 2022 Jan 13.

  PMID: 35028736 RESULT

• Derbyshire E, Hungin P, Nickerson C, Rutter MD. Post-polypectomy bleeding in the English National Health Service Bowel Cancer Screening Programme. Endoscopy. 2017 Sep;49(9):899-908. doi: 10.1055/s-0043-113442. Epub 2017 Jul 28.

  PMID: 28753697 RESULT

• Gavin DR, Valori RM, Anderson JT, Donnelly MT, Williams JG, Swarbrick ET. The national colonoscopy audit: a nationwide assessment of the quality and safety of colonoscopy in the UK. Gut. 2013 Feb;62(2):242-9. doi: 10.1136/gutjnl-2011-301848. Epub 2012 Jun 1.

  PMID: 22661458 RESULT

• Veitch AM, Radaelli F, Alikhan R, Dumonceau JM, Eaton D, Jerrome J, Lester W, Nylander D, Thoufeeq M, Vanbiervliet G, Wilkinson JR, Van Hooft JE. Endoscopy in patients on antiplatelet or anticoagulant therapy: British Society of Gastroenterology (BSG) and European Society of Gastrointestinal Endoscopy (ESGE) guideline update. Gut. 2021 Sep;70(9):1611-1628. doi: 10.1136/gutjnl-2021-325184.

  PMID: 34362780 RESULT

• Boakye E, Uddin SMI, Obisesan OH, Osei AD, Dzaye O, Sharma G, McEvoy JW, Blumenthal R, Blaha MJ. Aspirin for cardiovascular disease prevention among adults in the United States: Trends, prevalence, and participant characteristics associated with use. Am J Prev Cardiol. 2021 Sep 22;8:100256. doi: 10.1016/j.ajpc.2021.100256. eCollection 2021 Dec.

  PMID: 34632437 RESULT

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• James Yun Wong Lau, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James Yun Wong Lau, MD

CONTACT

+85235051445; laujyw@surgery.cuhk.edu.hk

Cecilia Chan, PhD

CONTACT

35052640; ceciliachan@surgery.cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 29, 2025
• First Posted: July 7, 2025
• Study Start: February 10, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2031
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

HK (1)