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

3 1 1 1

What is this study about?

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.

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 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 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 polypectomy procedure

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

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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Clinico Universitario Lozano Blesa Zaragoza Spain
Hospital Obispo Polanco Teruel Spain
Hbpyifqi Uhyuycbvflqfq Dlymbbbo Donostia / San Sebastian Spain
Hlvjdbff Uvrijumgufkym Dg Crosorua Gijon Spain
Hmlkybop Db Lv Spqnf Clse I Sblf Pwb Barcelona Spain
Hxfhectz Uxmqzgekrltlh Hcopzxgg Twhlt y Puyijf Igoxsmmt Cjxpxr dxddasxbvwjtelfyx (nmli Badalona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Recruiting
17.06.2024

Trial locations

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.

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 ID:
2024-511265-11-01
Protocol code:
ICI22/00054
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

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

    Recruiting

    3 1 1 1
    Spain