Centre Hospitalier Universitaire De Bordeaux
Bordeaux, France
Rare diseases
Investigational molecules
Locations
A plain-language summary of the goals, design and what participants do
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.
The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.
5 criteria
8 criteria
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Bordeaux, France
Toulouse, France
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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.
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.
Aspirin is typically administered orally in tablet form. It is widely used in medicine as an antiplatelet agent to prevent blood clots. The main therapeutic indication for aspirin in this context is to reduce the risk of stroke in patients with atrial fibrillation following left atrial appendage closure. At the molecular level, aspirin works by inhibiting the enzyme cyclooxygenase, which in turn reduces the formation of thromboxane, a molecule that promotes platelet aggregation. It is classified as a non-steroidal anti-inflammatory drug (NSAID) with antiplatelet properties.
Clopidogrel is administered orally, usually in tablet form. It is a well-established medication in the medical field, primarily used as an antiplatelet agent. The main therapeutic indication for clopidogrel in this trial is to prevent ischemic events in patients with atrial fibrillation after left atrial appendage closure, when used in combination with aspirin. Clopidogrel works by inhibiting the P2Y12 receptor on platelets, which prevents platelet aggregation and reduces the risk of clot formation. It is classified as a thienopyridine antiplatelet drug.
sourced from the EU Clinical Trials Register and site verification
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