Study to evaLuate the effIcacy and Safety of abeLacimab in High-risk Patients With Atrial Fibrillation Who Have Been Deemed Unsuitable for Oral antiCoagulation (LILAC-TIMI 76)

To join this study, you would generally need to have atrial fibrillation or atrial flutter, which has been confirmed by a heart tracing (ECG). You would also need to meet certain age criteria: either between 65 and 74 years old with a specific score indicating a higher risk of stroke, or 75 years or older with a slightly lower risk score.

A key part of joining is that your doctor must believe that standard blood-thinning medications are not suitable for you, either because the risks of bleeding are too high, or you've decided you don't want to take them. This decision must have been made before you consider joining this study. You would also need to have at least one factor that increases your risk of bleeding, such as kidney problems, regularly taking other blood-thinning medicines (antiplatelets) for other conditions, or a history of bleeding. Another important point is that your doctor must also have decided that a procedure to close off part of your heart (called left atrial appendage closure) is also not suitable for you, or you don't want to have it.

There are also some reasons why you wouldn't be able to join. For example, if your atrial fibrillation is due to a temporary cause that can be fixed, like recent heart surgery or an overactive thyroid. You also wouldn't be able to join if you've recently taken certain blood thinners, had a recent bleed in your brain or eye, or had a stroke or mini-stroke very recently. If you have a mechanical heart valve or certain types of heart valve disease, you would also not be able to participate. The study team will go through all the criteria with you to see if it's a good fit.

Taking part in this study would involve getting either the new medicine, abelacimab, or a dummy medicine. You wouldn't know which one you're getting, nor would your study doctor. This is standard practice in clinical trials to ensure fair results. You would receive this medicine regularly throughout the study. You'd have regular appointments at the study clinic for check-ups, which might include blood tests, ECGs, and discussions about how you're feeling and any new health issues. The study team will explain the full schedule of visits and tests. You would be followed for a significant period to monitor how well the medicine works and to check for any side effects. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.