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 study about?

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.

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Bellvitge University Hospital	L'hospitalet De Llobregat	Spain
Hospital Clinico San Carlos	Madrid	Spain

Other Sites

Site Name	City	Country
Hospital Clinic De Barcelona	Barcelona	Spain
Hospital Alvaro Cunqueiro	Vigo	Spain
Ivwqninbl Brugashy Pykcg Dk Mvqzdmma Sqzz	Palma	Spain
Aqct Da Sapxi Du Spsrxphvz	Salamanca	Spain
Hretpuzw Dj Lf Sbsor Cgjj I Srwj Pkc	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not yet recruiting	30.01.2025

Trial locations

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.

Investigated diseases:

Atrial fibrillation

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 ID:

2025-520954-12-00

Protocol code:

5072018

NCT ID:

NCT03568890

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?