NCT07185295

Short-term Interruption Versus Continuous Anticoagulation in Colorectal Polypectomy

Short-term Interruption Versus Continuous Anticoagulation in Colorectal Polypectomy, a Randomized Multicenter Investigator-initiated Non-inferiority Clinical Trial

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 481 (estimated)
• Sponsor: Outcomes'10 · Network
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to find out if it is safe to keep taking blood-thinning medicine during the removal of polyps from the colon or rectum. It includes patients who regularly take blood thinners and need an elective colonoscopy. The main goal is to see how often patients have serious bleeding after the polyp removal within 30 days. The study is being done in several hospitals, and doctors evaluating the results do not know which treatment patients receive.

Detailed description

This multicenter, phase IV, assessor-blinded, non-inferiority clinical trial evaluates the safety of maintaining oral anticoagulant therapy during colorectal polypectomy. The study population includes patients receiving chronic oral anticoagulation treatment with vitamin K antagonists (VKAs) or direct oral anticoagulants (DOACs) who are scheduled for elective colonoscopy for any indication. The primary objective is to assess the incidence of clinically significant post-polypectomy bleeding within 30 days after the procedure. The trial tests the hypothesis that continuing anticoagulant therapy during polypectomy is non-inferior to interrupting it, with a non-inferiority margin set at 10%. A total of 481 patients will be enrolled, with 241 patients per group. The intervention consists of maintaining ongoing anticoagulant treatment without modification before the procedure. This trial is classified as a low-intervention study according to regulatory guidelines and aims to provide evidence to optimize the management of anticoagulated patients undergoing colorectal polypectomy.

Conditions

• Anticoagulated Patients

Interventions

Type	Name	Description
PROCEDURE	To maintain anticoagulant therapy during the polypectomy of colorectal lesions	Group A

Timeline

• Start date: 2024-10-18
• Primary completion: 2026-11-18
• Completion: 2026-12-30
• First posted: 2025-09-22
• Last updated: 2025-11-24

Locations

10 sites across 1 country: Spain