Haemorrhage intracranial Trials in Disease

Study on Edoxaban for Patients with Atrial Fibrillation and Previous Brain Bleeding

This clinical trial is designed for patients who have previously experienced bleeding inside the skull and also have an irregular heart rhythm condition called atrial fibrillation. The study aims to investigate whether a blood-thinning medication called edoxaban can help reduce the risk of stroke and other blood clot-related complications in this specific group of patients.

Main inclusion criteria:

• You must be at least 45 years old
• You must have had a previous episode of bleeding inside the skull that caused noticeable symptoms and was either spontaneous or related to non-penetrating trauma
• You must have documented atrial fibrillation, which can be intermittent, persistent, or permanent
• You must have a CHA2DS2-VASc score of 2 or higher, which is a measure used to assess stroke risk in people with atrial fibrillation
• You must be able to provide written informed consent after understanding the study details

Main exclusion criteria:

• You cannot participate if you are currently taking other blood-thinning medications apart from the study drug
• You cannot join if you are pregnant or breastfeeding
• You are not eligible if you have allergies to the study medication or medical reasons that prevent you from taking it
• You cannot participate if you are already involved in another clinical trial at the same time
• You will be excluded if you have certain medical conditions that would make participation unsafe, as determined by the study doctors
• You cannot join if you are unable to follow the study procedures or attend the required visits

Study focus and goals:

The main goal of this study is to determine whether edoxaban is safe and effective in preventing strokes and other blood clot-related problems in patients who have both atrial fibrillation and a history of brain bleeding. This is a particularly challenging situation because while blood thinners help prevent strokes in people with atrial fibrillation, they can also increase the risk of bleeding. The study will compare patients taking edoxaban with those receiving either no blood thinners or a different type of medication called antiplatelet therapy.

Participants will be randomly assigned to receive either edoxaban tablets or a placebo, which looks like the medication but contains no active ingredients. The study will last for 12 weeks, during which participants will take their assigned tablets daily. Throughout this period, researchers will carefully monitor participants for any signs of stroke, blood clots, or bleeding events. The study is expected to be completed by April 2026.

Investigational drugs:

The main medication being tested is edoxaban, which is available in 60 mg and 30 mg doses as film-coated tablets taken once daily. Edoxaban is a type of anticoagulant, commonly known as a blood thinner, that works by blocking a specific protein involved in blood clot formation. This helps prevent dangerous clots from forming in the bloodstream.

The study also includes a comparison group receiving non-anticoagulant medical therapy. This means some participants may receive either no medication to prevent blood clots or an antiplatelet therapy instead. Antiplatelet medications work differently from blood thinners by preventing blood cells called platelets from sticking together to form clots. By comparing these different approaches, researchers hope to identify the safest and most effective treatment option for patients with atrial fibrillation who have previously experienced brain bleeding.