Short-term Interruption Versus Continuous Anticoagulation in Colorectal Polypectomy

NCT ID: NCT07185295

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 481 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-18
• Study Completion Date: 2026-12-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Maintained Anticoagulant Therapy

Patients in this treatment group will continue their anticoagulant therapy during the procedure. For those on vitamin K antagonists (VKAs), INR levels will be checked 7-14 days before the endoscopy, and doses adjusted if necessary to maintain therapeutic range (\<3.5) before the procedure. Patients on direct oral anticoagulants (DOACs) will skip only the morning dose on the day of the procedure without other changes.

Group Type: EXPERIMENTAL

To maintain anticoagulant therapy during the polypectomy of colorectal lesions

Intervention Type: PROCEDURE

Group A

Discontinued Anticoagulant Therapy

In patients assigned to this treatment arm, anticoagulation will be temporarily discontinued following the recommendations of the 2021 BSG-ESGE clinical practice guideline. The distinction between high and low thrombotic risk will be made according to guidelines.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

To maintain anticoagulant therapy during the polypectomy of colorectal lesions

Group A

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Age over 18 years.
• Patients scheduled for elective outpatient colonoscopy for any indication, in whom removal of colorectal polyps will be performed if identified during the procedure.
• Anticoagulant treatment with vitamin K antagonists (acenocoumarol or warfarin) or direct oral anticoagulants (dabigatran, edoxaban, apixaban, or rivaroxaban) prior to the colonoscopy.

Exclusion Criteria

• Concomitant antiplatelet therapy.

Age over 85 years.

Urgent colonoscopy.

Labile INR (time in therapeutic range less than 60%) documented in the previous 3 months in patients receiving VKAs.

Supratherapeutic INR (>3.5) at the time of the procedure in patients on VKAs.

Pregnancy.

Decompensated liver cirrhosis.

Inability, at the investigator's discretion, to understand the periprocedural anticoagulation regimen.

Known coagulopathy or bleeding diathesis, including platelet count <50,000/µl in the previous 12 months.

Scheduled endoscopic dilation.

Severe psychiatric disorder.

Removal of colorectal lesions by endoscopic submucosal dissection.

Previous diagnosis of renal failure defined as creatinine >2 mg/dl or clearance <30 ml/min.

Planned high bleeding risk procedure during simultaneous gastroscopy.

Previous inclusion in the trial. Patients may only be included once.

Patients who are not candidates for a second endoscopic intervention due to clinical conditions.

Any clinical situation or concomitant treatment that, in the investigator's opinion, poses a significant bleeding risk.

Patients with polyps larger than 4 cm pending endoscopic resection.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Outcomes'10

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clínica Rotger Quirónsalud

Palma, Balearic Islands, Spain

Servicio de Aparato Digestivo. Hospital Sierrallana. Barrio Ganzo,

Torrelavega, Cantabria, Spain

Servicio de Gastroenterología y Hepatología. Hospital Universitario Río Hortega.

Valladolid, Castille and León, Spain

Servicio de Digestología, Hospital del Mar. Instituto Hospital del Mar de Investigaciones Médicas.

Barcelona, Catalonia, Spain

Hospital Clinic de Barcelona

Barcelona, Catalonia, Spain

Servicio de Gastroenterología. Hospital Universitario Príncipe de Asturias. Madrid.

Alcalá de Henares, Madrid, Spain

Hospital Universitario Ramón y Cajal

Madrid, Madrid, Spain

Servicio de Gastroenterología y Hepatología. Unidad de Endoscopias. Hospital Universitario Puerta De Hierro.

Majadahonda, Madrid, Spain

Servicio de Gastroenterología y Hepatología. Hospital Universitario San Agustín.

Avilés, Principality of Asturias, Spain

Servicio de Aparato Digestivo. Hospital Universitario de Cabueñes

Oviedo, Principality of Asturias, Spain

Countries

Spain

Other Identifiers

ECA-HRC-POLYPHEM-04

Identifier Type: -

Identifier Source: org_study_id