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 study about?

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.

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 randomization

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

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 treatment duration

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

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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Azienda Ospedaliero Universitaria Di Sassari	Sassari	Italy
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy

Other Sites

Site Name	City	Country
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania	Catania	Italy
Azienda Sanitaria Locale Roma 2	Rome	Italy
Centro Cardiologico Monzino S.p.A.	Milan	Italy
Azienda Ospedaliera Ordine Mauriziano Di Torino	Turin	Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I G M Lancisi G Salesi	Ancona	Italy
Ssd Ematologia ASLTO4	Chivasso	Italy
Fondazione Toscana Gabriele Monasterio	Pisa	Italy
ASST Grande Ospedale Metropolitano Niguarda	Milan	Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga	Orbassano	Italy
Azienda Unita Sanitaria Locale Di Bologna	Bologna	Italy
Universita’ Di Pisa	Pisa	Italy
Azienda Ospedaliero-Universitaria Maggiore Della Carita	Novara	Italy
Apssfkz Skxrhdbxw Ljywje Tmt	Rivoli	Italy
Agdmypq Shhpcsosv Lkddhe Vyzrmeoy	Vercelli	Italy

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	01.10.2021

Trial locations

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.

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 ID:

2024-515361-34-00

Protocol code:

ARMYDA-AMULET

Trial Phase:

Therapeutic confirmatory (Phase III)

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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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?