Phase
Condition
Stroke
Cardiac Disease
Chest Pain
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patient age ≥18 years
- Symptomatic intracranial haemorrhage (i.e. intracerebral haemorrhage, non-aneurysmalsubarachnoid haemorrhage,intraventricular haemorrhage, or subduralhaemorrhage)
- Not attributable to a known underlying intracranial aneurysm, arteriovenousmalformation, cerebral cavernous malformation, dural arteriovenous fistula,intracranial venous thrombosis
- Not attributable to known head injury, based on:
- a history from the patient/witness of spontaneous symptom onset without precedinghead trauma (head trauma occurring after symptom onset is permissible)
- brain imaging appearances consistent with spontaneous intracranial haemorrhage (which may be accompanied by the brain/bone/soft tissue appearances of traumaoccurring subsequently)
- 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 bedone after symptomatic intracranial haemorrhage and before randomisation
Exclusion
Exclusion Criteria:
- Symptomatic intracranial haemorrhage within the last 24 hours (when the risk ofhaemorrhage expansion/growth is greatest)
- Symptomatic intracranial haemorrhage is exclusively due to trauma or haemorrhagictransformation of ischaemic stroke
- Prosthetic mechanical heart valve or severe (haemodynamically significant) nativevalve disease
- Left atrial appendage occlusion for prevention of systemic embolism in AF done in thepast, or intended to be performed
- Intention to start antiplatelet drug(s) if randomised to start full dose OAC
- Intention to start OAC or parenteral anticoagulation
- Intention to implement the allocated treatment strategy for <1 year
- Patient or their doctor is certain about whether to start or avoid full dose OAC
- Brain imaging that first diagnosed the intracranial haemorrhage is not available
- Patient is not registered with a general practitioner
- Patient is pregnant, breastfeeding, or of childbearing age and not takingcontraception
- Patient and carer unable to understand spoken or written English
- Contraindications to any of the IMPs, other than recent intracranial haemorrhage
- Contraindication to MRI (brain MRI sub-study)
- Life expectancy less than one year
- Previously randomised in SoSTART
Study Design
Study Description
Connect with a study center
Edinburgh Royal Infirmary
Edinburgh, Midlothian EH16 4SB
United KingdomSite Not Available
Aberdeen Royal Infirmary
Aberdeen, AB25 2ZN
United KingdomSite Not Available
Nevill Hall Hospital
Abergavenny, NP7 7EG
United KingdomSite Not Available
Monklands Hospital
Airdrie, ML6 0JS
United KingdomSite Not Available
Barnet Hospital
Barnet, EN5 3DJ
United KingdomSite Not Available
Royal United Hospital
Bath, BA1 3NG
United KingdomSite Not Available
Heartlands Hospital
Birmingham, B9 5SS
United KingdomSite Not Available
The Royal Bournemouth Hospital
Bournemouth, BH7 7DW
United KingdomSite Not Available
Bradford Royal Infirmary
Bradford, BD9 6RJ
United KingdomSite Not Available
University Hospital Bristol
Bristol, BS2 8HW
United KingdomSite Not Available
Addenbrookes Hospital
Cambridge, CB2 0QQ
United KingdomSite Not Available
University Hospital of Wales/ /University Hospital Llandough
Cardiff, CF14 4XW
United KingdomSite Not Available
Colchester General Hospital
Colchester, CO4 5JL
United KingdomSite Not Available
Derby Royal Hospital
Derby, DE22 3NE
United KingdomSite Not Available
Altnagelvin Hospital
Derry, BT47 6SB
United KingdomSite Not Available
Doncaster Royal Infirmary
Doncaster, DN2 5LT
United KingdomSite Not Available
University Hospital North Durham
Durham, DH1 5TW
United KingdomSite Not Available
South West Acute Hospital
Enniskillen, BT74 6DN
United KingdomSite Not Available
Royal Devon & Exeter Hospital
Exeter, EX2 5DW
United KingdomSite Not Available
Frimley Park Hospital
Frimley, GU16 7UJ
United KingdomSite Not Available
Queen Elizabeth Hospital
Gateshead, NE9 6SX
United KingdomSite Not Available
Medway Maritime Hospital
Gillingham, ME7 5NY
United KingdomSite Not Available
Glasgow Royal Infirmary
Glasgow, G4 0SF
United KingdomSite Not Available
Queen Elizabeth University Hospital
Glasgow, G51 4TF
United KingdomSite Not Available
Gloucestershire Royal Hospital
Gloucester, GL1 3NN
United KingdomSite Not Available
Calderdale Royal Hospital
Halifax, HX3 0PW
United KingdomSite Not Available
Northwick Park
Harrow, HA1 3UJ
United KingdomSite Not Available
Ystrad Mynach Hospital
Hengoed, CF82 7EP
United KingdomSite Not Available
Victoria Hospital Kirkcaldy
Kirkcaldy, KY2 5AH
United KingdomSite Not Available
Royal Lancaster Infirmary
Lancaster, LA1 4NU
United KingdomSite Not Available
Leeds General Infirmary
Leeds, LS13EX
United KingdomSite Not Available
Royal Liverpool and Broadgreen University Hospital
Liverpool, L78XP
United KingdomSite Not Available
University Hospital Aintree
Liverpool, L9 7 AL
United KingdomSite Not Available
Homerton University Hospital
London, E9 6SR
United KingdomSite Not Available
North Middlesex University Hospital
London, N18 1QX
United KingdomSite Not Available
St Thomas Hospital
London, SE1 7EH
United KingdomSite Not Available
St.George's Hospital
London, SW17 OQT
United KingdomSite Not Available
The Royal London Hospital
London, E1 1BB
United KingdomSite Not Available
University College London Hospital
London, NW1 2BU
United KingdomSite Not Available
Luton & Dunstable University Hospital
Luton, LU4 0DZ
United KingdomSite Not Available
King's Mill Hospital
Mansfield, NG17 4JL
United KingdomSite Not Available
James Cook University Hospital
Middlesbrough, TS4 3BW
United KingdomSite Not Available
Royal Victoria Infirmary
Newcastle Upon Tyne, NE1 4LP
United KingdomSite Not Available
Nottingham City Hospital
Nottingham, NG5 1PB
United KingdomSite Not Available
John Radcliffe Hospital
Oxford, OX3 9DU
United KingdomSite Not Available
Peterborough City Hospital
Peterborough, PE3 9GZ
United KingdomSite Not Available
Poole Hospital
Poole, BH15 2JB
United KingdomSite Not Available
Queen Alexandra Hospital
Portsmouth, PO6 3LY
United KingdomSite Not Available
Royal Preston Hospital
Preston, PR2 9HT
United KingdomSite Not Available
Royal Berkshire Hospital
Reading, RG1 5AN
United KingdomSite Not Available
Queen' Hospital Romford
Romford, RM7 0AG
United KingdomSite Not Available
Salford Royal NHS Foundation Trust
Salford, M6 8HD
United KingdomSite Not Available
Royal Hallamshire Hospital
Sheffield, S10 2JF
United KingdomSite Not Available
Southampton General Hospital
Southampton, SO16 6YD
United KingdomSite Not Available
University Hospital of North Tees
Stockton-on-Tees, TS19 8PE
United KingdomSite Not Available
Royal Stoke University Hospital
Stoke-on-Trent, ST4 6QG
United KingdomSite Not Available
Sunderland Royal Hospital
Sunderland, SR4 7TP
United KingdomSite Not Available
Morriston Hospital
Swansea, SA6 6NL
United KingdomSite Not Available
The Princess Royal Hospital
Telford, TF1 6TF
United KingdomSite Not Available
Torbay District General Hospital
Torquay, TQ2 7AA
United KingdomSite Not Available
Royal Cornwall Hospital
Truro, TR1 3LJ
United KingdomSite Not Available
Hillingdon Hospital
Uxbridge, UB8 3NN
United KingdomSite Not Available
Pinderfields Hospital
Wakefield, WF1 4DG
United KingdomSite Not Available
Southend University Hospital NHS Foundation Trust
Westcliff-on-Sea, SS0 0RY
United KingdomSite Not Available
Royal Hampshire County Hospital
Winchester, SO22 5DG
United KingdomSite Not Available
Arrowe Park Hospital
Wirral, CH49 5EP
United KingdomSite Not Available
New Cross Hospital
Wolverhampton, WV10 0QP
United KingdomSite Not Available
Yeovil District Hospital
Yeovil, BA21 4AT
United KingdomSite Not Available
York Hospital
York, YO31 8HE
United KingdomSite Not Available
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