Short-term Interruption Versus Continuous Anticoagulation in Colorectal Polypectomy (POLYPHEM)

Outcomes'10

Status and phase: Active, not recruiting; Phase 4

Conditions: Anticoagulated Patients

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

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT07185295

ECA-HRC-POLYPHEM-04

Details and patient eligibility

About

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.

Full 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.

Enrollment: 481 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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481 participants in 2 patient groups

Maintained Anticoagulant Therapy

Experimental group

Description:

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.

Treatment:

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

Discontinued Anticoagulant Therapy

No Intervention group

Description:

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.