The Risk of Bleeding After Removal of Large Colorectal Polyps in Patients Taking Aspirin

• Status: Unknown status
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Maria Sklodowska-Curie Institute - Oncology Center; Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
• Collaborator: Centre of Postgraduate Medical Education
• Treatments: Aspirin

Criteria

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