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Study Comparing Single and Dual Antiplatelet Therapy with Clopidogrel and Acetylsalicylic Acid for Patients with Atrial Fibrillation Undergoing Left Atrial Appendage Closure

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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 with atrial fibrillation, a condition where the heart beats irregularly, who are undergoing a procedure called percutaneous left atrial appendage closure using the Amulet device. The study aims to compare two different treatment strategies after this procedure. One group will receive a single medication, while the other group will receive two medications. The medications being studied are Plavix (which contains clopidogrel) and Cardioaspirin (which contains acetylsalicylic acid). These medications help prevent blood clots by stopping platelets, a type of blood cell, from sticking together.

The purpose of the study is to determine if using just one medication is as effective as using both medications together in preventing complications such as blood clots, bleeding, or death within six months after the procedure. Participants will be randomly assigned to one of the two treatment groups. The study will monitor the participants over a period of six months to observe any differences in outcomes between the two groups.

Throughout the study, participants will have regular follow-up visits to check their health and any side effects from the medications. The study will help doctors understand the best way to manage patients with atrial fibrillation who have undergone the left atrial appendage closure procedure, aiming to improve patient care and outcomes.

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

    Enrollment

    Upon joining the study, eligibility is confirmed based on specific criteria such as age, medical condition, and suitability for treatment with aspirin and clopidogrel.

    Informed consent is required, and a negative pregnancy test is necessary if applicable.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of two treatment groups: single antiplatelet therapy (SAPT) or dual antiplatelet therapy (DAPT).

  3. Step 3

    Treatment initiation

    For those in the SAPT group, treatment involves taking Plavix 75 mg film-coated tablets orally.

    Participants in the DAPT group take both Plavix 75 mg film-coated tablets and CARDIOASPIRIN 100 mg gastro-resistant tablets orally.

  4. Step 4

    Treatment duration

    The treatment continues for a period of 6 months, during which the effectiveness and safety of the therapies are monitored.

  5. Step 5

    Follow-up visits

    Scheduled follow-up visits occur throughout the study to assess health status and any potential side effects.

    Evaluations include monitoring for any bleeding events, thrombotic complications, or other health issues.

  6. Step 6

    Final assessment

    At the end of the 6-month period, a final assessment is conducted to evaluate the primary and secondary endpoints, including the incidence of death, stroke, and bleeding events.

Who can join the trial?

7 criteria

  • Men or women who are **18 years or older** and have signed a specific informed consent form.
  • Patients who have a planned **percutaneous LAA closure**. This is a procedure to close a part of the heart called the left atrial appendage.
  • Patients with **non-valvular atrial fibrillation (AF)**, which is a type of irregular heartbeat not caused by a heart valve problem. It can be paroxysmal (comes and goes), permanent (ongoing), or persistent (lasts longer than a week). They must have a **CHA2DS2-VASc score of 2 or more**, which is a way to measure the risk of stroke.
  • Patients who can be treated with **aspirin and clopidogrel**, which are medications that help prevent blood clots, according to their product guidelines.
  • Patients who are not suitable for long-term **oral anticoagulant therapy** because they have a high risk of bleeding. This could be due to other health conditions that make bleeding more likely, a history of bleeding, or if they are not expected to stick to the therapy.
  • Patients who are available to attend the follow-up visits that are scheduled for the study.
  • If applicable, patients must have a **negative pregnancy test** at the time of enrollment.

Who cannot join the trial?

4 criteria

  • Patients who are not undergoing a procedure called percutaneous left atrial appendage closure with the Amulet device. This is a medical procedure to help prevent blood clots in the heart.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
  • Patients who do not meet other specific criteria set by the study, which are not listed here.
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Investigated drugs

  • Aspirin

    is a medication used to reduce pain, fever, or inflammation. In this trial, it is used as part of a single antiplatelet therapy (SAPT) strategy to prevent blood clots after a procedure to close the left atrial appendage in the heart.

  • Clopidogrel

    is a medication that helps prevent blood clots by making it harder for platelets in the blood to stick together. In this study, it is used in combination with aspirin as part of a dual antiplatelet therapy (DAPT) strategy to reduce the risk of clotting complications after the heart procedure.

What is already known about the treatment

  • Aspirin

    Aspirin is typically administered orally in tablet form. It is widely recognized in medical literature as a common antiplatelet medication. It is primarily used to reduce the risk of blood clots, which can lead to heart attacks and strokes. At the molecular level, aspirin works by inhibiting an enzyme called cyclooxygenase, which in turn reduces the production of substances that promote inflammation and clotting. It is classified as a non-steroidal anti-inflammatory drug (NSAID) with antiplatelet properties.

  • Clopidogrel

    Clopidogrel is usually taken orally in tablet form. It is well-documented in medical literature as an antiplatelet agent. The main therapeutic use of clopidogrel is to prevent blood clots in patients with cardiovascular conditions, such as those undergoing procedures like percutaneous left atrial appendage closure. Clopidogrel works by blocking a receptor on platelets, preventing them from clumping together. It is classified as a thienopyridine antiplatelet drug.

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 blood clots to form in the heart. Over time, these clots can travel to other parts of the body, potentially causing strokes or other complications. The condition can be persistent or occur in episodes, and it may worsen over time. Symptoms can include palpitations, fatigue, and shortness of breath, although some individuals may not experience noticeable symptoms. Management often focuses on controlling the heart rate and reducing the risk of stroke.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515361-34-00Protocol codeARMYDA-AMULETEstimated enrolment606 patientsSponsorFondazione Toscana Gabriele Monasterio

sourced from the EU Clinical Trials Register and site verification

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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).