Start Or Stop Anticoagulants Randomised Trial
The main aim of this randomised controlled trial involving people with atrial fibrillation who have had a brain haemorrhage is to determine whether starting full dose oral anticoagulation is superior to avoiding oral anticoagulation for the prevention of all serious vascular events.
Bleeding within the skull, also known as brain haemorrhage, affects 3 million people in the world each year. One in five people who survive brain haemorrhage have an irregular heart rhythm called 'atrial fibrillation', which puts them at risk of stroke and other blood clots. Blood-thinning medicines, known as 'anticoagulant' drugs, are used in everyday clinical practice to protect people with atrial fibrillation from developing blood clots. However, these drugs also increase the risk of bleeding. Randomised controlled trials showed that anticoagulant drugs benefit people with atrial fibrillation. Randomised controlled trials are the fairest tests of treatments. However, these trials did not include people who had a history of brain haemorrhage. Recent published studies have observed what happened to people with brain haemorrhage and atrial fibrillation. These studies found that people who started anticoagulant drugs after brain haemorrhage were less likely to die, less likely to suffer blood clots, and were at similar risk of bleeding in comparison to people who did not start these drugs. However, these studies were not reliable because they were not randomised controlled trials.
This randomised controlled trial involves people with atrial fibrillation who have had a brain haemorrhage. The investigators want to produce reliable information about whether these people benefit from starting anticoagulant drugs.
These findings would be used to look after people with brain haemorrhage and atrial fibrillation in standard clinical practice in the NHS.
The Royal Preston Hospital (part of Lancashire Teaching Hospitals) has been a recruitment centre for this trial.
Further information about the trial can be found on the SoSTART website.