Start or STop Anticoagulants Randomised Trial (SoSTART)
United Kingdom203 participantsStarted 2018-03-28
Plain-language summary
Primary research question: For adults surviving spontaneous (non-traumatic) symptomatic intracranial haemorrhage with persistent/paroxysmal atrial fibrillation/flutter (AF), does starting full treatment dose oral anticoagulation (OAC) result in a beneficial net reduction of all serious vascular events compared with not starting OAC?
Trial design: Investigator-led, multicentre, randomised, open, assessor-masked, parallel group, clinical trial of investigational medicinal product (CTIMP) prescribing strategies. Investigators plan for a pilot phase, followed by a safety phase.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
✓. Atrial fibrillation/flutter (persistent or paroxysmal) with a CHA2DS2-VASc score ≥2
✓. If included in the brain magnetic resonance imaging (MRI) sub-study, the scan must be done after symptomatic intracranial haemorrhage and before randomisation
Exclusion criteria
✕. Symptomatic intracranial haemorrhage within the last 24 hours (when the risk of haemorrhage expansion/growth is greatest)
✕. Symptomatic intracranial haemorrhage is exclusively due to trauma or haemorrhagic transformation of ischaemic stroke
✕. Prosthetic mechanical heart valve or severe (haemodynamically significant) native valve disease
✕. Left atrial appendage occlusion for prevention of systemic embolism in AF done in the past, or intended to be performed
What they're measuring
1
The number of participants recruited per site per month (in the pilot phase of the trial)
Timeframe: 1 year after trial initiation
2
Recurrent symptomatic spontaneous intracranial haemorrhage (in the safety phase of the trial)