Start or STop Anticoagulants Randomised Trial (SoSTART)
Start or STop Anticoagulants Randomised Trial (SoSTART) after spontaneous intracranial haemorrhage
University of Edinburgh
17/SS/0082, REC Reference
Duration of Study in the UK
2 years, 0 months, 0 days
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 and are usually stopped when the brain haemorrhage occurs.
But when patients recover from brain haemorrhage, they and their doctors are often uncertain about whether to start or stop these drugs to prevent further clots occurring, or whether to avoid them in case they increase the risk of brain haemorrhage happening again.
We want to find out whether starting or not starting an anticoagulant drugs is better for those patients.
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.
In the pilot phase, we aim to recruit at least 60 participants to determine the feasibility of recruiting the target sample size of at least 800 participants in the main phase of the trial.
We will follow-up all participants for at least one year to determine whether prescribing an anticoagulant drug reduces the occurrence of all serious vascular events like heart attack, stroke compared with a policy of avoiding oral anticoagulant.
We want to produce reliable information about whether these people benefit from starting or avoiding anticoagulant drugs. These findings would be used to look after people with brain haemorrhage and atrial fibrillation in everyday clinical practice in the NHS.
Scotland A REC
Date of REC Opinion
11 Sep 2017
Further Information Favourable Opinion