Short-term Interruption Versus Continuous Anticoagulation in Colorectal Polypectomy

NCT07185295 | Active Not Recruiting Phase 4 DMC

• 1 other identifier: ECA-HRC-POLYPHEM-04
• Study Type: interventional
• Target: 481
• Locations: 1 country
• Sites: 10

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.

Conditions

Anticoagulated Patients

Keywords

Anticoagulant therapy; colorectal polypectomy; Oral anticoagulants; colonoscopy; Hemorrhage

Outcome Measures

Primary Outcomes (2)

• Clinically significant intraprocedural bleeding

  Major bleeding during colonoscopy that requires procedure interruption, a drop in hemoglobin \>2 g/dL, blood transfusion, interventional radiology, hospitalization, surgery, or results in death. The following data will be collected for bleeding events: * Date of the event. * Length of hospital stay: Quantitative nominal variable. Unit: days. * ICU admission: Binary variable (Yes/No). * Severity: Assessed according to the ASGE classification.

  1 month

• Clinically significant delayed hemorrhage

  Gastrointestinal bleeding occurring within 30 days after completion of the colonoscopy that requires an emergency visit, hospitalization, or an intervention. Date of the event. - Length of hospital stay: Quantitative nominal variable. Unit: days. - ICU admission: Binary variable (Yes/No). - Severity: Assessed according to the ASGE classification.

  1 month

Secondary Outcomes (8)

• Acute Myocardial Infarction

  1 month

• Hospitalization for Unstable Angina

  1 month

• Deep Vein Thrombosis

  1 month

• Pulmonary Embolism

  1 month

• Stroke, Including Transient Ischemic Attack

  1 month

Study Arms (2)

Maintained Anticoagulant Therapy

EXPERIMENTAL

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.

Procedure: To maintain anticoagulant therapy during the polypectomy of colorectal lesions

Discontinued Anticoagulant Therapy

NO INTERVENTION

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.

Interventions

To maintain anticoagulant therapy during the polypectomy of colorectal lesions PROCEDURE

Group A

Maintained Anticoagulant Therapy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Outcomes'10: lead

Study Sites (10)

Clínica Rotger Quirónsalud

Palma, Balearic Islands, 07012, Spain

Location

Servicio de Aparato Digestivo. Hospital Sierrallana. Barrio Ganzo,

Torrelavega, Cantabria, 39300, Spain

Location

Servicio de Gastroenterología y Hepatología. Hospital Universitario Río Hortega.

Valladolid, Castille and León, 47012, Spain

Location

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

Barcelona, Catalonia, 08003, Spain

Location

Hospital Clinic de Barcelona

Barcelona, Catalonia, 08036, Spain

Location

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

Alcalá de Henares, Madrid, 28805, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, Madrid, Spain

Location

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

Majadahonda, Madrid, 28222, Spain

Location

Servicio de Gastroenterología y Hepatología. Hospital Universitario San Agustín.

Avilés, Principality of Asturias, 33401, Spain

Location

Servicio de Aparato Digestivo. Hospital Universitario de Cabueñes

Oviedo, Principality of Asturias, 33011, Spain

Location

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: The intervention consists of managing anticoagulation in two different ways during colorectal polypectomy: Comparison of Temporary Interruption of Anticoagulation (Standard of Care) vs. Continuation of Anticoagulation (Interventional Arm)

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: September 22, 2025
• Study Start: October 18, 2024
• Primary Completion (Estimated): November 18, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (10)