Avoiding Anticoagulation After IntraCerebral Haemorrhage

This study is looking for adults aged 18 or older with no upper age limit. To be involved, you must have an irregular heartbeat (atrial fibrillation) that has been confirmed by a heart tracing (ECG) and usually need long-term anti-clotting medication to prevent strokes. You must also have had a brain bleed (intracerebral haemorrhage) at some point, which was confirmed by a brain scan like a CT or MRI. This brain bleed must have happened more than 14 days ago. Importantly, both you and your doctor must be unsure about the best way to prevent future strokes and show interest in trying one of the study's approaches.

There are certain reasons why you might not be able to join the study. For example, if you have severe movement problems after your brain bleed, or if you need anti-clotting medicine for another serious condition (like a mechanical heart valve). You also can't take part if you've had other major bleeding problems in the last six months (apart from your brain bleed), if doctors expect you to live for less than a year, or if you are pregnant or breastfeeding.

Also, if a doctor thinks the heart procedure to close the left atrial appendage isn't suitable for you (for example, if a scan shows a clot there, or you're over 85, or doctors aren't comfortable doing it), then you wouldn't be able to be in that part of the study. Similarly, if you have very poor kidney function, weigh less than 50kg, are allergic to Apixaban, have conditions that mean you often hit your head, or if you or your doctor don't want to use Apixaban, then you wouldn't be able to be in the Apixaban group.

If you decide to take part in this study, you'll be assigned by chance to one of three groups: one group will receive a blood-thinning drug called Apixaban, another group will have a procedure to close a part of the heart called the left atrial appendage, and the third group will receive usual care, meaning they will not have Apixaban or the heart procedure within the study. This decision about which group you are in is made randomly, like flipping a coin.

For those in the Apixaban group, you would take this medication twice a day. If you are in the Left Atrial Appendage Closure group, you would undergo a procedure to seal off a small pouch in your heart. Regardless of your assigned group, you will have regular check-ups and assessments with the study team. These will involve clinic visits and possibly some tests. The study will carefully follow your health for two years to see how you are doing, looking at whether you have any strokes, other serious events, or bleeding. The total duration of your active follow-up in the study will be 24 months.