Start or STop Anticoagulants Randomised Trial (SoSTART)
NCT ID: NCT03153150
Last Updated: 2022-04-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
203 participants
INTERVENTIONAL
2018-03-28
2021-03-26
Brief Summary
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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.
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Detailed Description
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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.
Investigators 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, investigators aim to recruit at least 60 participants to determine the feasibility of recruiting the target sample size of at least 190 participants in the safety phase of the trial.
Investigators 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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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.
Apixaban
The participant will be allocated to start this oral anticoagulant drug, if the participant's doctor indicated it before randomisation.
Rivaroxaban
The participant will be allocated to start this oral anticoagulant drug, if the participant's doctor indicated it before randomisation.
Edoxaban
The participant will be allocated to start this oral anticoagulant drug, if the participant's doctor indicated it before randomisation.
Dabigatran
The participant will be allocated to start this oral anticoagulant drug, if the participant's doctor indicated it before randomisation.
Acenocoumarol
The participant will be allocated to start this oral anticoagulant drug, if the participant's doctor indicated it before randomisation.
Phenindione
The participant will be allocated to start this oral anticoagulant drug, if the participant's doctor indicated it before randomisation.
Warfarin
The participant will be allocated to start this oral anticoagulant drug, if the participant's doctor indicated it before randomisation.
Do not start oral anticoagulant (OAC)
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.
No interventions assigned to this group
Interventions
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Apixaban
The participant will be allocated to start this oral anticoagulant drug, if the participant's doctor indicated it before randomisation.
Rivaroxaban
The participant will be allocated to start this oral anticoagulant drug, if the participant's doctor indicated it before randomisation.
Edoxaban
The participant will be allocated to start this oral anticoagulant drug, if the participant's doctor indicated it before randomisation.
Dabigatran
The participant will be allocated to start this oral anticoagulant drug, if the participant's doctor indicated it before randomisation.
Acenocoumarol
The participant will be allocated to start this oral anticoagulant drug, if the participant's doctor indicated it before randomisation.
Phenindione
The participant will be allocated to start this oral anticoagulant drug, if the participant's doctor indicated it before randomisation.
Warfarin
The participant will be allocated to start this oral anticoagulant drug, if the participant's doctor indicated it before randomisation.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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)
3. Atrial fibrillation/flutter (persistent or paroxysmal) with a CHA2DS2-VASc score ≥2
4. 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
2. Symptomatic intracranial haemorrhage is exclusively due to trauma or haemorrhagic transformation of ischaemic stroke
3. Prosthetic mechanical heart valve or severe (haemodynamically significant) native valve disease
4. Left atrial appendage occlusion for prevention of systemic embolism in AF done in the past, or intended to be performed
5. Intention to start antiplatelet drug(s) if randomised to start full dose OAC
6. Intention to start OAC or parenteral anticoagulation
7. Intention to implement the allocated treatment strategy for \<1 year
8. Patient or their doctor is certain about whether to start or avoid full dose OAC
9. Brain imaging that first diagnosed the intracranial haemorrhage is not available
10. Patient is not registered with a general practitioner
11. Patient is pregnant, breastfeeding, or of childbearing age and not taking contraception
12. Patient and carer unable to understand spoken or written English
13. Contraindications to any of the IMPs, other than recent intracranial haemorrhage
14. Contraindication to MRI (brain MRI sub-study)
15. Life expectancy less than one year
16. Previously randomised in SoSTART
18 Years
ALL
No
Sponsors
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NHS Lothian
OTHER_GOV
University of Edinburgh
OTHER
Responsible Party
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Principal Investigators
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Rustam Al-Shahi Salman, MA PhD FRCP
Role: PRINCIPAL_INVESTIGATOR
University of Edinburgh
Locations
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Edinburgh Royal Infirmary
Edinburgh, Midlothian, United Kingdom
Aberdeen Royal Infirmary
Aberdeen, , United Kingdom
Nevill Hall Hospital
Abergavenny, , United Kingdom
Monklands Hospital
Airdrie, , United Kingdom
Barnet Hospital
Barnet, , United Kingdom
Royal United Hospital
Bath, , United Kingdom
Heartlands Hospital
Birmingham, , United Kingdom
The Royal Bournemouth Hospital
Bournemouth, , United Kingdom
Bradford Royal Infirmary
Bradford, , United Kingdom
University Hospital Bristol
Bristol, , United Kingdom
Addenbrookes Hospital
Cambridge, , United Kingdom
University Hospital of Wales/ /University Hospital Llandough
Cardiff, , United Kingdom
Colchester General Hospital
Colchester, , United Kingdom
Derby Royal Hospital
Derby, , United Kingdom
University Hospital North Durham
Durham, , United Kingdom
South West Acute Hospital
Enniskillen, , United Kingdom
Royal Devon & Exeter Hospital
Exeter, , United Kingdom
Frimley Park Hospital
Frimley, , United Kingdom
Queen Elizabeth Hospital
Gateshead, , United Kingdom
Medway Maritime Hospital
Gillingham, , United Kingdom
Glasgow Royal Infirmary
Glasgow, , United Kingdom
Queen Elizabeth University Hospital
Glasgow, , United Kingdom
Gloucestershire Royal Hospital
Gloucester, , United Kingdom
Calderdale Royal Hospital
Halifax, , United Kingdom
Northwick Park
Harrow, , United Kingdom
Ystrad Mynach Hospital
Hengoed, , United Kingdom
Victoria Hospital Kirkcaldy
Kirkcaldy, , United Kingdom
Royal Lancaster Infirmary
Lancaster, , United Kingdom
Leeds General Infirmary
Leeds, , United Kingdom
Royal Liverpool and Broadgreen University Hospital
Liverpool, , United Kingdom
University Hospital Aintree
Liverpool, , United Kingdom
The Royal London Hospital
London, , United Kingdom
Homerton University Hospital
London, , United Kingdom
North Middlesex University Hospital
London, , United Kingdom
University College London Hospital
London, , United Kingdom
St Thomas Hospital
London, , United Kingdom
St.George's Hospital
London, , United Kingdom
Altnagelvin Hospital
Londonderry, , United Kingdom
Luton & Dunstable University Hospital
Luton, , United Kingdom
King's Mill Hospital
Mansfield, , United Kingdom
Arrowe Park Hospital
Metropolitan Borough of Wirral, , United Kingdom
James Cook University Hospital
Middlesbrough, , United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, , United Kingdom
Nottingham City Hospital
Nottingham, , United Kingdom
John Radcliffe Hospital
Oxford, , United Kingdom
Peterborough City Hospital
Peterborough, , United Kingdom
Poole Hospital
Poole, , United Kingdom
Royal Preston Hospital
Preston, , United Kingdom
Royal Berkshire Hospital
Reading, , United Kingdom
Queen' Hospital Romford
Romford, , United Kingdom
Salford Royal NHS Foundation Trust
Salford, , United Kingdom
Royal Hallamshire Hospital
Sheffield, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
University Hospital of North Tees
Stockton-on-Tees, , United Kingdom
Royal Stoke University Hospital
Stoke-on-Trent, , United Kingdom
Sunderland Royal Hospital
Sunderland, , United Kingdom
Morriston Hospital
Swansea, , United Kingdom
The Princess Royal Hospital
Telford, , United Kingdom
Torbay District General Hospital
Torquay, , United Kingdom
Royal Cornwall Hospital
Truro, , United Kingdom
Hillingdon Hospital
Uxbridge, , United Kingdom
Pinderfields Hospital
Wakefield, , United Kingdom
Southend University Hospital NHS Foundation Trust
Westcliff-on-Sea, , United Kingdom
Royal Hampshire County Hospital
Winchester, , United Kingdom
New Cross Hospital
Wolverhampton, , United Kingdom
Yeovil District Hospital
Yeovil, , United Kingdom
York Hospital
York, , United Kingdom
Countries
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References
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SoSTART Collaboration. Effects of oral anticoagulation for atrial fibrillation after spontaneous intracranial haemorrhage in the UK: a randomised, open-label, assessor-masked, pilot-phase, non-inferiority trial. Lancet Neurol. 2021 Oct;20(10):842-853. doi: 10.1016/S1474-4422(21)00264-7. Epub 2021 Sep 3.
Cochrane A, Chen C, Stephen J, Ronning OM, Anderson CS, Hankey GJ, Al-Shahi Salman R. Antithrombotic treatment after stroke due to intracerebral haemorrhage. Cochrane Database Syst Rev. 2023 Jan 26;1(1):CD012144. doi: 10.1002/14651858.CD012144.pub3.
Li L, Poon MTC, Samarasekera NE, Perry LA, Moullaali TJ, Rodrigues MA, Loan JJM, Stephen J, Lerpiniere C, Tuna MA, Gutnikov SA, Kuker W, Silver LE, Al-Shahi Salman R, Rothwell PM. Risks of recurrent stroke and all serious vascular events after spontaneous intracerebral haemorrhage: pooled analyses of two population-based studies. Lancet Neurol. 2021 Jun;20(6):437-447. doi: 10.1016/S1474-4422(21)00075-2.
Related Links
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Trial website
Chief investigator details
Other Identifiers
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2016-004121-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SoSTART2016
Identifier Type: -
Identifier Source: org_study_id
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