| Trial name or title |
Start or STop Anticoagulants Randomised Trial |
| Methods |
Investigator‐led, multicentre, randomised, open, assessor‐masked, parallel group, clinical trial of investigational medicinal product (CTIMP) prescribing strategies. We plan for a pilot phase, followed by a main phase. |
| Participants |
Inclusion criteria: spontaneous intracranial haemorrhage, AF and a CHA2DS2‐VASc score ≥ 2
Exclusion criteria:
Patient age < 18 years Intracranial haemorrhage within the last 24 hours Brain imaging that first diagnosed the intracranial haemorrhage is not available Intracranial haemorrhage is exclusively due to trauma or haemorrhagic transformation of ischaemic stroke. Patient or their doctor is certain about whether to start or avoid full oral anticoagulation Patient is not registered with a general practitioner Patient is pregnant, breastfeeding, or of childbearing age and not taking contraception Patient and carer unable to understand spoken or written English Previously randomised in SoSTART
Brain MRI substudy: MRI must be done after intracranial haemorrhage but before randomisation. Substudy participants must not have contraindications to MRI. |
| Interventions |
Start full OAC: (either a non‐vitamin K antagonist DOAC or warfarin if a DOAC cannot be used), chosen by the participant’s physician before randomisation Start antiplatelet drug(s) (if the participant has an indication for antiplatelet drugs) or avoid all antithrombotic drugs (if the participant does not have an indication for antiplatelet drugs), specified by the participant’s doctor before randomisation |
| Outcomes |
Primary outcome: all symptomatic serious vascular events (i.e. major adverse cardiac or cerebrovascular events: MACCE) including non‐fatal stroke, non‐fatal acute coronary syndrome, vascular death, sudden death, or death of unknown cause
Secondary outcomes:
individual symptomatic vascular events; individual types of fatal events; dependence according to the mRS
|
| Starting date |
2017 |
| Contact information |
Professor Rustam Al‐Shahi Salman, University of Edinburgh, UK (Rustam.Al‐Shahi@ed.ac.uk) |
| Notes |
Funded by Chest Heart and Stroke Scotland |
