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Stroke is a major cause of death and disability in Europe, and its impact is expected to rise as the population ages.
Most strokes are ischaemic, which means they are caused by a blood clot in the brain, while approximately 10-15 % of stroke patients suffer from bleeding in the brain caused by a torn blood vessel, known as an intracerebral haemorrhage. This type of stroke is linked to a much higher risk of disability and death compared to an ischaemic stroke. The EU-funded project PRESTIGE-AF is investigating how to improve stroke prevention for patients who have had a brain haemorrhage.
The elevated risk of a stroke repeat can be due to heartbeat irregularities experienced by around 20 % of brain haemorrhage patients – a condition called atrial fibrillation (AF), which is a growing health problem and a major cause of ischaemic stroke. Patients with AF usually take anti-clotting drugs called oral anticoagulants to lower the risk of a blood clot forming in the heart and reduce the risk of another stroke. However, there is evidence that anti-clotting drugs could raise the risk of another brain haemorrhage.
‘Whether or not to prescribe anticoagulants for stroke prevention in brain haemorrhage patients with AF has been an unresolved medical dilemma for decades,’ says PRESTIGE-AF project coordinator Roland Veltkamp, professor of neurology at Imperial College London. ‘It’s a question that needs urgent attention because recurrent stroke reduces individual life expectancy, impairs quality of life and has a high public health impact.’
New generation anticoagulants
PRESTIGE-AF’s main objective is to discover whether patients with AF who have had a brain haemorrhage should be treated with anticoagulants or not. To answer this question, the team have set up a clinical trial that will assess the effectiveness of a newer generation of anti-clotting drugs called direct oral anticoagulants. Patients taking part in the trial will either be prescribed one of four of these anticoagulants or receive no anti-clotting medication.
The trial, which is in its early phases, will include 654 patients in Austria, Germany, Spain, France, Italy and the UK. This is the first time such an extensive trial with a large sample size has been carried out. The project is also using data from national stroke registries in countries including Denmark and Taiwan to estimate the impact of the trial results over a larger population size.
‘Observational trials support the case for giving anticoagulants, but these could be biased, and the evidence is not clear. Our trial will provide reliable evidence and help health practitioners give the right medicine to improve the lives of AF stroke patients by reducing the risk of another stroke,’ says Veltkamp.
Personalised prediction tools
In addition to the general recommendations on anticoagulation drugs that will result from the trial, the PRESTIGE-AF researchers aim to develop a personalised stroke prediction tool for patients with AF. They will do this by analysing the individual’s blood-based biomarkers, brain imaging and examining the individual’s genetics. The tool will allow doctors to design a personalised post-stroke care strategy for these vulnerable patients.
PRESTIGE-AF also hopes to discover more about the patients’ and doctors’ attitudes towards anti-clotting medication by asking questions about adherence and their perceptions of the anticoagulants. Finally, the project will explore gender difference with the aim of understanding why fewer women take part in stroke prevention trials than men.