This clinical trial is focused on studying the prevention of stroke or systemic embolism in people with atrial fibrillation, a condition where the heart beats irregularly and often rapidly. The study is comparing two treatments: asundexian (also known by its code name BAY 2433334) and apixaban, which is marketed under the name Eliquis. Both medications are taken orally in the form of film-coated tablets. The purpose of the study is to determine how well asundexian works and how safe it is compared to apixaban in preventing stroke or systemic embolism in individuals with atrial fibrillation who are at risk for stroke.
Participants in the study will be randomly assigned to receive either asundexian or apixaban. Some participants will receive a placebo, which is a substance with no active medication, to help compare the effects of the treatments. The study will be conducted in a double-blind manner, meaning neither the participants nor the researchers will know who is receiving which treatment, to ensure unbiased results. The trial will last for a period of up to 33 days, during which the safety and effectiveness of the treatments will be closely monitored.
The main goal is to see if asundexian is at least as effective as apixaban in preventing stroke and systemic embolism, and to assess the risk of major bleeding, which is a significant concern with blood-thinning medications. The study will also look at other outcomes, such as the occurrence of minor bleeding, cardiovascular events, and overall mortality. This research aims to provide valuable information on the potential benefits and risks of asundexian compared to apixaban for people with atrial fibrillation at risk of stroke.
Who Can Join the Study?
You must be 18 years of age or older at the time you sign the agreement to join the study.
You must have atrial fibrillation, which is an irregular and often rapid heart rhythm that can cause blood to pool in the heart.
Your heart rhythm must be confirmed by an ECG, which is a test that records the electrical activity of your heart.
You must require long-term treatment with an oral anticoagulant, which is a type of medicine taken by mouth that helps prevent blood clots from forming.
You must have a specific risk score, known as a CHA2DS2-VASc score, which is a tool doctors use to estimate the likelihood of having a stroke based on certain health factors.
For men, this score must be 3 or higher, or 2 if certain other specific study requirements are met.
For women, this score must be 4 or higher, or 3 if certain other specific study requirements are met.
Who Cannot Join the Study?
Having a mechanical heart valve prosthesis, which is an artificial valve surgically placed in the heart to replace a damaged natural valve.
Having moderate-to-severe mitral stenosis, a condition where the mitral valve (one of the heart’s valves) becomes narrow and stiff, making it difficult for blood to flow through the heart.
Having atrial fibrillation—an irregular and often rapid heart rhythm—that is caused only by a reversible cause, meaning a condition that can be easily fixed or cured.
Needing chronic anticoagulation, which is long-term medication used to thin the blood and prevent clots, for any reason other than atrial fibrillation.
Asundexian is a medication being tested to see how well it prevents blood clots that could lead to a stroke or other serious issues in people with an irregular heartbeat called atrial fibrillation. It works by blocking a specific protein in the blood that helps clots form.
Apixaban is an existing medication used to prevent blood clots, such as those that cause strokes or systemic embolism, in people with atrial fibrillation. In this study, it is used as a comparison to see how effective it is against the new medication.
Atrial fibrillation – This is an irregular and often rapid heart rhythm that can cause many different symptoms. It occurs when the upper chambers of the heart beat out of sync with the lower chambers. During this condition, the heart’s electrical signals become disorganized. This irregular beating can cause blood to pool in the heart. Over time, this pooling can lead to the formation of blood clots. These clots may then travel through the bloodstream to other parts of the body.
Stroke – A stroke occurs when the blood supply to part of the brain is interrupted or reduced. This interruption prevents brain tissue from getting necessary oxygen and nutrients. Brain cells can begin to die within minutes due to this lack of blood flow. This condition can also be caused by a blood vessel in the brain bursting. The damage to the brain can affect various bodily functions depending on the location.
Systemic embolism – This condition happens when a blood clot or other foreign object travels through the bloodstream. The object moves from its original location and becomes stuck in a blood vessel in a different part of the body. This blockage can restrict blood flow to vital organs or limbs. The location of the blockage determines which part of the body is affected. It is often a result of a clot forming in the heart or large arteries.
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