Clinical trial · Interventional
The Risk of Bleeding After Removal of Large Colorectal Polyps in Patients Taking Aspirin
The Risk of Bleeding After Removal of Large Colorectal Polyps in Patients Continuing or Discontinuing on Aspirin: a Multicenter, Double-blind, Placebo-controlled, Randomized Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The risk of bleeding after polypectomy of large colorectal polyps in patients taking aspirin is uncertain. This is a randomized, multi-center, placebo-controlled, double-blind study to compare the risk of significant bleeding after endoscopic polypectomy of large (\>=10mm) colorectal polyps in patients continuing or discontinuing on daily acetylsalicylic acid (ASA) use. Eligible patients will be randomly assigned in a 1:1 ratio to a group taking 75mg daily ASA or placebo 7 days before and 14 days following polypectomy. The primary endpoint of the study is bleeding within 30 days from colorectal polypectomy. The secondary endpoints are composite cardiovascular events occurring between the date of randomization and 30 days after polypectomy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal Hemorrhage | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aspirin (ASA) | Drug | Aspirin | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Aspirin
- description
- Patients with at least one large polyps taking aspirin in dose 75 mg daily for 21 days (7 days before and 14 days after polypectomy)
- interventionNames
- Drug: Aspirin (ASA)
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Patients with at least one large polyps taking placebo daily for 21 days (7 days before and 14 days after polypectomy)
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Clinically significant bleeding after colorectal polypectomy
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 40 years or older 2. Daily aspirin for primary or secondary prophylaxis 3. Candidate for endoscopic polypectomy of at least one colorectal polyp 10mm or larger 4. Signed written informed consent 5. Written opinion from a cardiologist that the patient can cease taking aspirin for a period of 21 days in the peri-polypectomy period Exclusion Criteria: 1. Lifelong anticoagulant therapy with warfarin, acenocumarol 2. Concurrent antiplatelet treatment with clopidogrel or ticlopidin 3. Coagulation disorders INR \> 1,5, APTT 2xnorm 4. Known hemorrhagic disorder
References
Publications (0)
Data not yet available