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Myocardial Infarction (MI)Phase 3NCT07052799

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

A Phase 3 study testing Aspirin 80mg in people with Myocardial Infarction (MI) and Cardiovascular Events, run by Chinese University of Hong Kong at 1 site in Hong Kong.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Aspirin 80mg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,514 participants
Where
1 siteHong Kong
Study dates
10 Feb 2026to 31 Dec 2031
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Hong Kong1 site, 1 recruiting
  • Prince of Wales Hospital

    Hong Kong

    James Lau, MD, 852-35051445 ext. 1411, laujyw@surgery.cuhk.edu.hk

    Cecilia Chan, PhD, 852-35052640 ext. 2640, ceciliachan@surgery.cuhk.edu.hk

    Recruiting

Other trials in Hong Kong

About this study

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

Read the detailed description

Aspirin is commonly prescribed to patients for protection against cardiovascular diseases.In 2019, the prevalence of aspirin use was 35.6% in the US. Patients with vascular diseases are at increased risk of having colorectal neoplasms and therefore often undergo screening colonoscopy and possible polypectomy. The management of aspirin before and after colonoscopy and polypectomy has been a contentious subject. The updated British Society of Gastroenterologists (BSG) and ESGE guidelines recommend continuing aspirin except for ESD and EMR > 2cm. The recommendation is based on the low rate of bleeding complications in large cohort studies. In a BSG audit of 20085 colonoscopies in the UK, 52 (0.26%) cases of bleeding were reported. In the English National Bowel Cancer Screening Programme, 69,028 underwent polypectomy.The overall rate of PPB was 1.14% (4). In large series mostly retrospective (> 1000 polypectomies), delayed PPB varied from 0.6 to 2.2 %, and the mean time to onset of bleeding was 4.0 ± 2.9 days (5). The use of aspirin did not emerge to be a factor predicting delayed bleeding. The evidence for continuing aspirin to reduce CV events is conflicting. In an early trial (6) on 220 subjects undergoing non-cardiac surgery, aspirin continuation was associated with a 7.2% risk reduction in postoperative major adverse cardiac events. In the STRATAGEM trial that enrolled 291 patients undergoing general surgery, no difference in thrombotic or bleeding events was observed between groups.The POISE-2 trial was considered the most definitive. It was a placebo-controlled trial that studied patients undergoing again noncardiac surgery, 351 of 4998 patients (7.0%) in the aspirin group and 355 of 5012 patients (7.1%) in the placebo group reached the primary outcome endpoint (death or non-fatal infarcts). Major bleeding was more common in the aspirin group (4.6% vs. 3.8%, P=0.04).Continuation of aspirin was associated with a higher risk of bleeding but did not protect against CV events. There exist variations in clinical practice. A survey of endoscopy centres in the U.S. showed that 44% of endoscopy units recommend continuing aspirin, 33% recommend stopping aspirin and 24% suggest that patients seek advice from a physician. Many endoscopists are concerned about post-polypectomy bleeding and its associated medico-legal risks. In the context of colonoscopy and polypectomy, there has been no randomized comparison between the two strategies of continuing or withholding aspirin. The investigators therefore undertake an RCT to compare cardiovascular and bleeding outcomes in patients undergoing colonoscopy with/without polypectomy. The investigators are planning a large RCT sufficiently powered to detect small differences in these outcomes.

Being tested
Aspirin 80mg, Placebo Oral Tablet
Keywords
Aspirin continuation or interruption, polypectomy, cardiovascular events
Medical subject headings
Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aspirin 80mgDrug

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

  • Placebo Oral TabletDrug

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

Study groups in NCT07052799
Study groupRoleWhat they receive
aspirinActive comparator8-day (-5, +3) supply of aspirin 80mg before and after colonoscopy
Receives: Drug: Aspirin 80mg
PlaceboPlacebo comparator8-day (-5, +3) supply of placebo 80mg before and after colonoscopy
Receives: Drug: Placebo Oral Tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. cardiovascular events

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

    Measured: 30 days

Secondary outcomes (2)
  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

    Measured: 30 days

  2. mortality by all causes

    mortality by all causes

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2025
  2. Study start10 Feb 2026
  3. Primary completion31 Dec 2030 (estimated)
  4. Study completion31 Dec 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
2,514 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07052799
Sponsor's protocol ID
Aspirin Colon Study
Status last verified
Mar 2026
First submitted
29 Jun 2025
Last updated
18 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 38670139
  • 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.

    PubMed 11786451
  • 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.

    PubMed 25975531
  • 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.

    PubMed 24679062
  • 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.

    PubMed 21873632
  • 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.

    PubMed 20150346
  • 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.

    PubMed 35028736
  • 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.

    PubMed 28753697
  • 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.

    PubMed 22661458
  • 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.

    PubMed 34362780
  • 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.

    PubMed 34632437

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Aspirin 80mg in people with Myocardial Infarction (MI) and Cardiovascular Events, run by Chinese University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact James Yun Wong Lau, MD (+85235051445 ext. 1411, laujyw@surgery.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

cardiovascular events (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07052799, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.

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