At the heart of the PRESTIGE-AF project is a clinical trial looking at the best stroke prevention for patients who have had an intracerebral haemorrhage (bleeding within the brain), and have a common heart arrhythmia called atrial fibrillation, as well as several sub-studies that participants can choose to take part in.
These studies will explore other factors such as individual risk prediction, genetics, blood-based biomarkers, drug adherence and exposure, and psychological and cognitive factors.
This page contains information about the PRESTIGE-AF clinical trial and sub-studies, but if you or a loved one are interested in taking part, a clinician at your local PRESTIGE-AF study site will talk you through it in more detail and provide you with the necessary consent forms.
At the heart of the PRESTIGE-AF project is a clinical trial looking to see if patients with atrial fibrillation who have had an intracerebral haemorrhage should receive anticoagulant medication to decrease the likelihood of further stroke.
The PRESTIGE-AF clinical trial plans to recruit 654 patients from several countries across Europe to help answer this question.
Participants are randomly assigned to one of two groups:
The direct oral anticoagulants (DOACs) that will be used in this trial are all licensed for use in the United Kingdom and within the European Union (EU) to prevent strokes in people with atrial fibrillation. However, the current licence does not extend to use with people who have had an intracerebral haemorrhage because it has not been tested in this group with a randomised controlled trial. This is why we are doing this clinical trial.
The trial is using DOACs because previous research trials have shown that people are up to 50% less likely to have complications such as bleeding in the brain with DOACs than with Warfarin (another commonly used anticoagulant).
There are three sub-studies that participants in the PRESTIGE-AF clinical trial can opt to take part in.
This sub-study aims to see if trial participants have any changes in their brains that have occurred without any noticeable symptoms.
Participants who opt into this sub-study will have one MRI brain scan that will be performed one year after they have been enrolled in the main PRESTIGE-AF study, which will take around 30 minutes.
An MRI scan poses no health risk because it does not use radiation (like an X-Ray), instead it uses a strong magnetic field and radio waves to produce images.
This sub-study looks at how easy it is to adhere to the anticoagulant medication treatment plan, as well as how well the medication is absorbed by the body, as this can be influenced by several factors.
Only participants who are in the group receiving anticoagulants can opt into this sub-study. Those who do will have the drug level in their blood measured with blood taken at their scheduled visits to their study centre, with the option of collecting additional drops of blood at home and answering regular short surveys.
This sub-study aims to develop tools for the prediction of individual risk of subsequent ischaemic or haemorrhagic stroke in patients with atrial fibrillation, who have had a previous intracerebral haemorrhage.
It will look for clues in the participant’s blood and DNA, as well as information from clinical data and brain imaging, to see if anything could be indicative of a higher risk of suffering another stroke or could affect the participant’s response to anticoagulant medications.
The only additional procedure for this sub-study is a single collection of a blood sample that can be taken at the same time as the participant’s main study blood test.