Study on Aspirin and Clopidogrel for Patients with Atrial Fibrillation After Left Atrial Appendage Closure

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What is this study about?

This clinical trial is focused on studying the effects of two different treatments for patients with Atrial Fibrillation, a condition where the heart beats irregularly. The study involves patients who have undergone a procedure called left atrial appendage closure (LAAC), which is used to prevent strokes in people who cannot take blood thinners. The trial will compare the effectiveness of two antithrombotic strategies: one group will receive aspirin alone, while the other group will receive a combination of aspirin and clopidogrel, a medication that helps prevent blood clots.

The purpose of the study is to evaluate how well these treatments work in preventing new ischemic lesions in the brain, which are areas of tissue damage caused by a lack of blood flow. These lesions will be monitored using MRI scans of the brain, taken within 24 hours after the procedure and again after three months. The study will also look at other outcomes, such as any new symptoms of stroke or bleeding events, and assess the overall health and cognitive function of the participants over the three-month period.

Participants in the study will be monitored closely, with regular check-ups and assessments to ensure their safety and to gather data on the effectiveness of the treatments. The trial aims to provide valuable information on the best strategy for preventing complications in patients with atrial fibrillation who have undergone LAAC, ultimately helping to improve patient care and outcomes.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, medical condition, and consent.

The study focuses on patients with a condition called atrial fibrillation who have undergone a procedure known as left atrial appendage closure.

2 initial assessment

An initial brain MRI scan is performed within 24 hours after the procedure to check for any ischemic lesions, which are areas of restricted blood flow in the brain.

3 medication administration

Two different medication strategies are evaluated: one group receives aspirin alone, and the other group receives a combination of aspirin and clopidogrel.

Aspirin is administered as KARDEGIC 160 mg oral solution, and clopidogrel is administered as Plavix 75 mg film-coated tablets.

These medications are taken orally as prescribed by the study protocol.

4 follow-up assessments

A follow-up brain MRI scan is conducted after 3 months to compare with the initial scan and assess any new ischemic lesions.

Neurological examinations are performed at day 1 and month 3 to check for any symptoms of cerebral events such as strokes or transient ischemic attacks.

5 additional evaluations

Cognitive assessments are conducted using the Montreal Cognitive Assessment (MoCA) scale at day 1 and month 3.

The presence of any thrombus on the prosthesis and other related evaluations are performed using a cardiac CT scan at 3 months.

6 treatment compliance

Compliance with the medication regimen is assessed at month 3 by comparing the medications taken with those prescribed.

This compliance is analyzed in relation to any thromboembolic or hemorrhagic events that may occur.

Who Can Join the Study?

Male or female patients who need a procedure called LAAC. This is a treatment for a heart condition where a small part of the heart is closed off to prevent blood clots.
Must be 18 years or older.
Must provide written informed consent, which means you agree to participate after being fully informed about the study.
Approval from a heart team, which is a group of doctors including heart specialists and brain specialists, who agree that you should not take blood-thinning medications.
Must be registered under the social security system, which means you have access to healthcare services.

Who Cannot Join the Study?

Patients with a history of bleeding disorders. This means any condition that makes it hard for the blood to clot properly.
Patients who have had a stroke in the last 6 months. A stroke is when blood flow to a part of the brain is stopped, causing brain cells to die.
Patients with severe kidney disease. This is when the kidneys are not working well enough to clean the blood properly.
Patients with severe liver disease. This is when the liver is not working well enough to perform its normal functions.
Patients who are allergic to aspirin or clopidogrel. These are medications used to prevent blood clots.
Patients who are pregnant or breastfeeding. This means women who are expecting a baby or are nursing a baby.
Patients who are participating in another clinical trial. This means being involved in another study at the same time.
Patients with any other condition that the study doctors think would make it unsafe to participate. This means any health issue that could cause problems if the patient joins the study.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Oncopole Claudius Regaud	Toulouse	France

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
France	Recruiting	03.10.2022

Trial locations

Investigated drugs:

Aspirin is a medication used to reduce pain, fever, or inflammation. In this trial, it is being used as an antithrombotic strategy to prevent blood clots following a procedure called left atrial appendage closure (LAAC). The study aims to see how effective aspirin is in preventing ischemic lesions in the brain after the procedure.

Clopidogrel is another medication that helps prevent blood clots. It is often used in combination with aspirin to enhance the antithrombotic effect. In this trial, clopidogrel is being used alongside aspirin to evaluate if the combination is more effective than aspirin alone in preventing ischemic lesions in the brain after the LAAC procedure.

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. 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 be associated with symptoms like palpitations, fatigue, or shortness of breath. Over time, atrial fibrillation can weaken the heart and lead to heart failure if not managed properly. It is often related to other heart conditions, high blood pressure, or age-related changes in the heart.

Trial ID:

2024-515774-27-00

Protocol code:

CHUBX2017/29

NCT ID:

NCT04796714

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Aspirin and Clopidogrel for Patients with Atrial Fibrillation After Left Atrial Appendage Closure

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?