What is SoSTART?

What question will SoSTART address? Why are we asking it?

Background to the research

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.

We aim to perform a randomised controlled trial involving people with atrial fibrillation who have had a brain haemorrhage.
We 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.

A network of hospital doctors, nurses, and other staff will identify people who survive brain haemorrhage and have atrial fibrillation.
If a patient and their doctor are uncertain about whether to start an anticoagulant drug, they may invite the patient to participate.
Staff will provide the patient, their legal representative, or their nearest relative with information leaflets about this trial.
After consent is given, a patient can undergo an additional detailed magnetic scan of their brain, known as MRI, which would not always happen in standard practice. After the MRI scan, each patient will be allocated at random to either starting or not starting an anticoagulant drug. There is a 1 in 2, or 50%, chance of receiving either strategy.
If the patient is allocated to start anticoagulant drugs, the patient’s doctor will prescribe their choice of anticoagulant drug for the patient.
If the patient is allocated to not start anticoagulant drugs, the patient’s doctor will not prescribe an anticoagulant drug.
We will follow-up all participants for at least one year to determine whether prescribing an anticoagulant drug improves outcome.