Short-term Interruption Versus Continuous Anticoagulation in Colorectal Polypectomy

Phase 4Active Not RecruitingNCT07185295

Outcomes'10481 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

481

Conditions

Anticoagulated Patients

Interventions

To maintain anticoagulant therapy during the polypectomy of colorectal lesionsPROCEDURE

Group A

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Locations (10)

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

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 1 month

Secondary Outcomes

Acute Myocardial Infarction

A clinical syndrome characterized by evidence of myocardial necrosis in a clinical setting consistent with acute myocardial ischemia. Data collected will include event date, hospital stay duration, and ICU stay duration.

Time frame: 1 month

Hospitalization for Unstable Angina

Unscheduled hospitalization for the treatment of unstable angina occurring within 24 hours from symptom onset. Hospitalization is defined as admission to an inpatient unit or an emergency department visit resulting in a stay of at least 24 hours. Data collected will include event date, hospital stay duration, and ICU stay duration.

Time frame: 1 month

Deep Vein Thrombosis

Any deep vein thrombosis diagnosed in the upper body (internal jugular, subclavian, axillary/brachial) or lower extremities (iliac, femoral/popliteal, gastrocnemius, peroneal, posterior tibial), or in the inferior vena cava or deep splanchnic veins, as confirmed by ultrasound or contrast imaging techniques including computed tomography (CT), angiography, or magnetic resonance imaging (MRI). Data collected will include event date, hospital stay duration, and ICU stay duration.

Data from ClinicalTrials.gov

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