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Study on the Safety of Continuing Apixaban, Clopidogrel, and Rivaroxaban During Polyp Removal in Patients on Antiplatelet or Anticoagulant Therapy

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 need a colonoscopy and are taking medications called antiplatelets or anticoagulants. These medications help prevent blood clots but can increase the risk of bleeding. The study will look at the safety of continuing these medications during a procedure called a cold snare polypectomy, which is used to remove small, non-pedunculated colorectal polyps. The main goal is to see if the risk of bleeding after the procedure is similar whether patients continue their medication or stop it according to current medical guidelines.

The trial will involve several medications, including Apixaban, Clopidogrel, Rivaroxaban, Dabigatran Etexilate, Edoxaban, and Acenocoumarol. These medications are taken orally, meaning they are swallowed in pill form. The study will compare the effects of these medications on bleeding risks during and after the polypectomy procedure. Some patients will continue their medication, while others will stop taking it as per usual medical practice.

The study will last for a period of up to eight weeks for each participant. During this time, participants will undergo the polypectomy procedure and be monitored for any signs of bleeding or other complications. The aim is to ensure that continuing these medications does not increase the risk of significant bleeding compared to stopping them. This information will help doctors make better decisions about managing medications during such procedures in the future.

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

    Upon joining the study, eligibility is confirmed. Participants are between 18 and 80 years old and are undergoing a colonoscopy for any reason. Participants are on chronic antiplatelet therapy (excluding ASA) or anticoagulant treatment.

  2. Step 2

    Medication regimen

    Participants continue their current antiplatelet or anticoagulant medication. The medications involved include apixaban, clopidogrel, rivaroxaban, dabigatran etexilate, edoxaban, and acenocoumarol. All medications are taken orally.

  3. Step 3

    Procedure preparation

    Participants prepare for the colonoscopy procedure. The study focuses on the removal of non-pedunculated polyps smaller than 10mm using a cold snare technique.

  4. Step 4

    Polypectomy procedure

    During the colonoscopy, the cold snare polypectomy is performed. The procedure involves removing small polyps from the colon.

  5. Step 5

    Post-procedure monitoring

    After the procedure, participants are monitored for any signs of significant bleeding, which is the primary focus of the study. Monitoring continues to ensure there are no immediate or delayed hemorrhagic events.

  6. Step 6

    Study completion

    The study is estimated to conclude by October 31, 2026. Participants will have completed their involvement once all necessary data is collected and analyzed.

Who can join the trial?

5 criteria

  • Patients must be between 18 and 80 years old.
  • A colonoscopy must have been requested for any reason.
  • Patients must be on long-term antiplatelet therapy (except for ASA, which is aspirin) or anticoagulant treatment. These are medications that help prevent blood clots.
  • Both men and women can participate.
  • Participants should not be part of a vulnerable population, meaning they should not have conditions that make them more at risk in a clinical trial.

Who cannot join the trial?

1 criterion

  • Patients who need a colonoscopy for any reason and are taking **antiplatelet** medications (except **ASA**) or **anticoagulant** medications cannot participate. **Antiplatelet** medications help prevent blood cells from sticking together and forming a clot. **ASA** is a common antiplatelet medication, also known as aspirin. **Anticoagulant** medications are drugs that help prevent blood clots by thinning the blood.
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Investigated drugs

  • Antiplatelets

    are medications that help prevent blood cells called platelets from sticking together and forming clots. In this clinical trial, they are being studied to see if continuing their use during a procedure to remove small polyps in the colon increases the risk of bleeding compared to stopping them before the procedure.

  • Anticoagulants

    are medications that help prevent blood clots by thinning the blood. This trial is examining whether patients who continue taking anticoagulants during the removal of small colon polyps have a higher risk of bleeding compared to those who stop taking them before the procedure.

What is already known about the treatment

  • Antiplatelet Medication

    This medication is typically administered orally and is used to prevent blood clots by inhibiting platelet aggregation. It is currently well-established in medical practice and literature for its role in reducing the risk of stroke and heart attack in patients with cardiovascular conditions. The main therapeutic indication for this medication is to prevent clot formation in patients who are at risk of thrombotic events. At the molecular level, it works by blocking specific receptors on platelets, preventing them from clumping together. It is classified pharmacologically as an antiplatelet agent.

  • Anticoagulant Medication

    This medication is usually taken orally or administered via injection and is used to prevent blood clots by interfering with the blood coagulation process. It is widely recognized in medical literature and practice for its effectiveness in preventing and treating conditions like deep vein thrombosis and pulmonary embolism. The primary therapeutic indication is to reduce the risk of clot formation in patients with conditions such as atrial fibrillation. Its mechanism of action involves inhibiting specific factors in the blood clotting cascade, thereby reducing the ability of blood to form clots. It is classified as an anticoagulant.

Investigated diseases

Post-Polypectomy Hemorrhage – This condition occurs when bleeding happens after the removal of polyps from the colon during a procedure called a colonoscopy. Polyps are small growths that can develop on the lining of the colon. The bleeding can be immediate or delayed, meaning it can happen right after the procedure or some time later. The risk of this bleeding can be influenced by factors such as the size and type of the polyp, as well as the patient's use of certain medications like antiplatelets or anticoagulants. In some cases, the bleeding may be significant, requiring medical attention. The condition is generally managed by monitoring and supportive care, depending on the severity of the bleeding.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511265-11-01Protocol codeICI22/00054Estimated enrolment686 patientsSponsorFundacion Instituto De Investigacion Sanitaria Aragon

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