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Study Comparing Dabigatran Etexilate, Acetylsalicylic Acid, and Clopidogrel for Preventing Blood Clots in Patients with Atrial Fibrillation After Heart Procedure

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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 studying the prevention of blood clots in patients with Atrial Fibrillation who have undergone a procedure called Left Atrial Appendage Closure (LAAC). Atrial Fibrillation is a common heart condition that causes an irregular and often rapid heart rate, which can lead to blood clots. The trial aims to compare two types of treatments: short-term use of anticoagulation therapy and antiplatelet therapy. Anticoagulation therapy involves medications that help prevent blood clots, while antiplatelet therapy involves medications that prevent blood cells called platelets from clumping together to form clots.

The medications being studied in this trial include Dabigatran Etexilate, Apixaban, Rivaroxaban, Edoxaban, Clopidogrel, and Aspirin. These medications are taken orally, meaning they are swallowed in the form of tablets or capsules. The trial will also include a group of participants who will receive a placebo, which is a substance with no active medication, to compare the effects of the actual medications. The purpose of the study is to see which treatment is more effective in preventing device-related blood clots after the LAAC procedure.

Participants in the study will be monitored over a period of time to observe the occurrence of any blood clots or other related health events. The study will last for about eight weeks, during which the participants will receive one of the treatments. After this period, the participants will be checked for any signs of blood clots using medical imaging techniques like computed tomography or transesophageal echocardiography (TEE), which is a type of ultrasound that provides images of the heart. The study will also track any other health events such as strokes or bleeding incidents over a longer period to ensure the safety and effectiveness of the treatments.

The research process

The trial runs in 5 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 successful completion of a procedure called left atrial appendage closure (LAAC).

    Eligibility requires being at least 18 years old and having undergone the LAAC procedure with an approved device.

  2. Step 2

    Medication assignment

    Participants are assigned to receive either short-term anticoagulation therapy or antiplatelet therapy.

    Anticoagulation therapy involves taking a direct oral anticoagulant (DOAC) for 8 weeks. Options include dabigatran etexilate, apixaban, edoxaban, or rivaroxaban, all administered orally.

    Antiplatelet therapy involves taking acetylsalicylic acid (aspirin) or clopidogrel, also administered orally.

  3. Step 3

    Initial follow-up

    After 60 days, a test called transesophageal echocardiography (TEE) is performed to check for any blood clots on the device.

    The primary goal is to evaluate the presence of device thrombosis, which is a clot formation on the device.

  4. Step 4

    Safety monitoring

    Safety is monitored by checking for any adverse events such as death, stroke, bleeding, or device thrombosis within 60 days.

    These events are assessed by the study investigators to determine if any changes in treatment are necessary.

  5. Step 5

    Long-term follow-up

    Further evaluations occur at 12 months using TEE or computed tomography to check for device thrombosis.

    Additional follow-ups for ischemic events like stroke or transient ischemic attack (TIA) and bleeding events are conducted at 2 months, and annually up to 5 years.

Who can join the trial?

4 criteria

  • Patients who have successfully undergone **Left Atrial Appendage Closure (LAAC)** with any approved device. LAAC is a procedure to close a small pouch in the heart to prevent blood clots.
  • Must be **18 years old or older**.
  • Both **male and female** patients can participate.
  • Participants should not belong to a vulnerable population, meaning they should be able to make decisions for themselves and not be in a situation where they are easily influenced or at risk.

Who cannot join the trial?

4 criteria

  • Patients who have a history of atrial fibrillation (a condition where the heart beats irregularly) cannot participate.
  • Patients who have experienced device thrombosis (a blood clot forming on a medical device) after a procedure called Left Atrial Appendage Closure (a procedure to prevent blood clots in the heart) are excluded.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are part of a vulnerable population, such as those unable to give consent, are not eligible.
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Investigated drugs

  • Anticoagulation Therapy (DOAC)

    is a treatment used to prevent blood clots. In this trial, it is given for a short period of 8 weeks to see if it can effectively prevent clots from forming on a device placed in the heart. This therapy works by thinning the blood, making it less likely for clots to form.

  • Antiplatelet Therapy

    is another type of treatment aimed at preventing blood clots. It works differently from anticoagulation therapy by stopping blood cells called platelets from sticking together. This therapy is also being tested in the trial to see if it can prevent clots on the heart device as effectively as the anticoagulation therapy.

What is already known about the treatment

DOAC (Direct Oral Anticoagulant) – This medication is taken orally and is used to prevent blood clots. It is currently being studied in clinical trials to determine its effectiveness in preventing device thrombosis after a procedure called Left Atrial Appendage Closure (LAAC). The main therapeutic use of DOACs is to reduce the risk of stroke and blood clots in patients with conditions like atrial fibrillation. At the molecular level, DOACs work by inhibiting specific proteins in the blood that are necessary for clot formation. They are classified as anticoagulants, which are medications that help prevent the formation of harmful blood clots.

Investigated diseases

  • Atrial Fibrillation

    Atrial fibrillation is a common heart rhythm disorder where the heart's upper chambers (atria) beat irregularly and often rapidly. This irregular rhythm can lead to poor blood flow and may cause symptoms like palpitations, fatigue, and shortness of breath. Over time, the condition can increase the risk of stroke and heart failure. The heart's electrical signals become chaotic, causing the atria to quiver instead of contracting effectively. This can result in blood pooling in the atria, potentially forming clots. These clots can travel to other parts of the body, leading to serious complications.

  • Device Thrombosis Post-Left Atrial Appendage Closure

    Device thrombosis post-left atrial appendage closure refers to the formation of a blood clot on a device used to close the left atrial appendage of the heart. This procedure is often performed to reduce the risk of stroke in patients with atrial fibrillation. After the device is implanted, there is a risk that a clot may form on its surface. This can occur if the device does not fully seal the appendage or if the blood flow around the device is not optimal. The presence of a clot can lead to complications such as stroke or other embolic events. Monitoring and follow-up are essential to ensure the device is functioning properly and to manage any potential risks.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-520954-12-00Protocol code5072018Estimated enrolment500 patientsSponsorCentre Hospitalier Universite De Laval

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).