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Study on Short-term Interruption vs. Continuous Anticoagulation with Apixaban in Patients Undergoing Colorectal Polypectomy

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on patients who are taking oral anticoagulant medications and are scheduled for a planned colonoscopy, a procedure to examine the inside of the colon. The study is investigating the safety of continuing anticoagulation treatment during the removal of polyps, which are small growths in the colon. The medications being studied include Apixaban, Acenocoumarol, Dabigatran Etexilate, Warfarin, Rivaroxaban, and Edoxaban. These medications are used to prevent blood clots and are known as anticoagulants.

The purpose of the study is to evaluate whether it is safe to maintain anticoagulation treatment during the removal of polyps in the colon. Participants in the study will either continue their anticoagulation medication or have a short-term interruption of the medication during the procedure. The study will monitor for any bleeding or clotting events after the procedure to determine the safety of each approach.

This trial is designed to help understand the best way to manage anticoagulation treatment during colonoscopy procedures, ensuring patient safety while effectively preventing blood clots. The study is expected to run until May 2026, with recruitment starting in May 2024.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after meeting the inclusion criteria: being 18 years or older, undergoing an elective outpatient colonoscopy, and receiving anticoagulant treatment with either VKA (such as acenocoumarol or warfarin) or OACD (such as dabigatran, edoxaban, apixaban, or rivaroxaban).

  2. Step 2

    Medication administration

    The trial involves the use of oral anticoagulants. The specific medication and dosage will be determined based on the current treatment plan. The medications include apixaban, acenocoumarol, warfarin, rivaroxaban, and edoxaban.

  3. Step 3

    Procedure preparation

    Preparation for the colonoscopy will follow standard medical guidelines. The trial aims to evaluate the safety of maintaining anticoagulation treatment during the procedure.

  4. Step 4

    Colonoscopy and polypectomy

    During the colonoscopy, polyps may be removed. The trial compares short-term interruption versus continuous anticoagulation during this procedure.

  5. Step 5

    Post-procedure monitoring

    After the procedure, monitoring for any bleeding or clotting events will occur. This is to assess the primary endpoint of the trial, which is the occurrence of hemorrhage and thromboembolic events post-polypectomy.

  6. Step 6

    Follow-up

    Follow-up appointments will be scheduled to ensure recovery and to monitor any delayed effects of the procedure or medication.

Who can join the trial?

3 criteria

  • Must be **18 years or older**.
  • Must be scheduled for an **elective outpatient colonoscopy**. This means a planned procedure where a doctor looks inside the colon using a special camera.
  • Must be receiving **anticoagulant treatment**. This refers to medications that help prevent blood clots. The specific medications include VKA (such as acenocoumarol or warfarin) or OACD (such as dabigatran, edoxaban, apixaban, or rivaroxaban) before the colonoscopy.

Who cannot join the trial?

4 criteria

  • Patients who are not receiving oral anticoagulant therapy. This means if you are not taking medication to prevent blood clots, you cannot participate.
  • Patients who are not scheduled for an elective colonoscopy. This means if you do not have a planned procedure to examine your colon, you cannot participate.
  • Patients who are under the age of 18 or over the age of 65. This means if you are younger than 18 or older than 65, you cannot participate.
  • Patients who belong to a vulnerable population. This means if you are in a group that needs special protection, you cannot participate.
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Investigated drugs

Anticoagulation Treatment is a therapy used to prevent blood clots. In this trial, it is being studied to see if it is safe to continue this treatment during the removal of polyps from the colon, a procedure known as polypectomy. The goal is to determine if keeping patients on their regular anticoagulation medication is as safe as stopping it temporarily during the procedure.

What is already known about the treatment

Warfarin – Warfarin is an oral medication used to prevent blood clots by thinning the blood. It is commonly prescribed for patients with conditions like atrial fibrillation, deep vein thrombosis, or those with mechanical heart valves. The medication works by inhibiting the synthesis of vitamin K-dependent clotting factors, which are essential for blood clot formation. Warfarin is classified as an anticoagulant and is well-documented in medical literature. In the context of the POLYPHEM trial, it is being studied to assess the safety of continuing its use during colorectal polypectomy procedures.

Investigated diseases

  • Haemorrhage

    Haemorrhage refers to the escape of blood from a ruptured blood vessel, which can occur internally or externally. It may result from injury, surgery, or certain medical conditions. The severity can range from minor to severe, depending on the location and amount of blood loss. In some cases, it can lead to symptoms like dizziness, weakness, or shock if not managed promptly. The body may attempt to stop the bleeding through clotting mechanisms, but medical intervention is often required to control significant haemorrhage.

  • Thromboembolic Events

    Thromboembolic events occur when a blood clot forms in a blood vessel and subsequently travels to another part of the body, potentially causing blockages. These events can lead to conditions such as deep vein thrombosis or pulmonary embolism. The formation of clots can be influenced by factors like immobility, certain medical conditions, or medications. Symptoms may vary depending on the location of the clot but can include pain, swelling, or difficulty breathing. The body's natural clot-dissolving processes may address small clots, but larger ones often require medical attention.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512194-27-01Estimated enrolment394 patientsSponsorHospital Universitario Ramon Y Cajal

sourced from the EU Clinical Trials Register and site verification

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