Start or STop Anticoagulants Randomised Trial (SoSTART) (SoSTART)
Intracranial Hemorrhages, Intracranial Hemorrhage, Hypertensive, Subarachnoid Hemorrhage
About this trial
This is an interventional prevention trial for Intracranial Hemorrhages focused on measuring Oral anticoagulant, Factor Xa inhibitors, Direct thrombin inhibitor, Vitamin K antagonist, Antiplatelet drug
Eligibility Criteria
Inclusion Criteria:
- Patient age ≥18 years
Symptomatic intracranial haemorrhage (i.e. intracerebral haemorrhage, non-aneurysmal subarachnoid haemorrhage,intraventricular haemorrhage, or subduralhaemorrhage)
- Not attributable to a known underlying intracranial aneurysm, arteriovenous malformation, 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 preceding head 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 trauma occurring 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 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
- 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 taking contraception
- 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
Sites / Locations
- Edinburgh Royal Infirmary
- Aberdeen Royal Infirmary
- Nevill Hall Hospital
- Monklands Hospital
- Barnet Hospital
- Royal United Hospital
- Heartlands Hospital
- The Royal Bournemouth Hospital
- Bradford Royal Infirmary
- University Hospital Bristol
- Addenbrookes Hospital
- University Hospital of Wales/ /University Hospital Llandough
- Colchester General Hospital
- Derby Royal Hospital
- Altnagelvin Hospital
- University Hospital North Durham
- South West Acute Hospital
- Royal Devon & Exeter Hospital
- Frimley Park Hospital
- Queen Elizabeth Hospital
- Medway Maritime Hospital
- Glasgow Royal Infirmary
- Queen Elizabeth University Hospital
- Gloucestershire Royal Hospital
- Calderdale Royal Hospital
- Northwick Park
- Ystrad Mynach Hospital
- Victoria Hospital Kirkcaldy
- Royal Lancaster Infirmary
- Leeds General Infirmary
- Royal Liverpool and Broadgreen University Hospital
- University Hospital Aintree
- The Royal London Hospital
- Homerton University Hospital
- North Middlesex University Hospital
- University College London Hospital
- St Thomas Hospital
- St.George's Hospital
- Luton & Dunstable University Hospital
- King's Mill Hospital
- James Cook University Hospital
- Royal Victoria Infirmary
- Nottingham City Hospital
- John Radcliffe Hospital
- Peterborough City Hospital
- Poole Hospital
- Royal Preston Hospital
- Royal Berkshire Hospital
- Queen' Hospital Romford
- Salford Royal NHS Foundation Trust
- Royal Hallamshire Hospital
- Southampton General Hospital
- University Hospital of North Tees
- Royal Stoke University Hospital
- Sunderland Royal Hospital
- Morriston Hospital
- The Princess Royal Hospital
- Torbay District General Hospital
- Royal Cornwall Hospital
- Hillingdon Hospital
- Pinderfields Hospital
- Southend University Hospital NHS Foundation Trust
- Royal Hampshire County Hospital
- Arrowe Park Hospital
- New Cross Hospital
- Yeovil District Hospital
- York Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Start oral anticoagulant (OAC)
Do not start oral anticoagulant (OAC)
If the patient is randomized in this arm, an oral anticoagulant: Factor Xa inhibitors: Apixaban or Rivaroxaban or Edoxaban or Direct thrombin inhibitor: Dabigatran or Vitamin K antagonists: Acenocoumarol or Phenindione or Warfarin chosen by the patient's physician before the randomisation, will be prescribed long-term (≥1 year) to the patient.
If the patient is randomized in this arm, anticoagulant drugs will not be prescribed to the patient during the entire study period. The standard clinical practice without OAC may include: antiplatelet drug(s) or no antithrombotic drugs.