Start or STop Anticoagulants Randomised Trial (SoSTART)

Last updated: March 31, 2022
Sponsor: University of Edinburgh
Overall Status: Completed

Phase

3

Condition

Stroke

Cardiac Disease

Chest Pain

Treatment

N/A

Clinical Study ID

NCT03153150
SoSTART2016
2016-004121-16
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patient age ≥18 years
  2. 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)
  1. Atrial fibrillation/flutter (persistent or paroxysmal) with a CHA2DS2-VASc score ≥2
  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:

  1. Symptomatic intracranial haemorrhage within the last 24 hours (when the risk ofhaemorrhage expansion/growth is greatest)
  2. Symptomatic intracranial haemorrhage is exclusively due to trauma or haemorrhagictransformation of ischaemic stroke
  3. Prosthetic mechanical heart valve or severe (haemodynamically significant) nativevalve disease
  4. Left atrial appendage occlusion for prevention of systemic embolism in AF done in thepast, 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 takingcontraception
  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

Study Design

Total Participants: 203
Study Start date:
March 28, 2018
Estimated Completion Date:
March 26, 2021

Study Description

Bleeding within the skull, also known as brain haemorrhage, affects 3 million people in the world each year.

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.

Connect with a study center

  • Edinburgh Royal Infirmary

    Edinburgh, Midlothian EH16 4SB
    United Kingdom

    Site Not Available

  • Aberdeen Royal Infirmary

    Aberdeen, AB25 2ZN
    United Kingdom

    Site Not Available

  • Nevill Hall Hospital

    Abergavenny, NP7 7EG
    United Kingdom

    Site Not Available

  • Monklands Hospital

    Airdrie, ML6 0JS
    United Kingdom

    Site Not Available

  • Barnet Hospital

    Barnet, EN5 3DJ
    United Kingdom

    Site Not Available

  • Royal United Hospital

    Bath, BA1 3NG
    United Kingdom

    Site Not Available

  • Heartlands Hospital

    Birmingham, B9 5SS
    United Kingdom

    Site Not Available

  • The Royal Bournemouth Hospital

    Bournemouth, BH7 7DW
    United Kingdom

    Site Not Available

  • Bradford Royal Infirmary

    Bradford, BD9 6RJ
    United Kingdom

    Site Not Available

  • University Hospital Bristol

    Bristol, BS2 8HW
    United Kingdom

    Site Not Available

  • Addenbrookes Hospital

    Cambridge, CB2 0QQ
    United Kingdom

    Site Not Available

  • University Hospital of Wales/ /University Hospital Llandough

    Cardiff, CF14 4XW
    United Kingdom

    Site Not Available

  • Colchester General Hospital

    Colchester, CO4 5JL
    United Kingdom

    Site Not Available

  • Derby Royal Hospital

    Derby, DE22 3NE
    United Kingdom

    Site Not Available

  • Altnagelvin Hospital

    Derry, BT47 6SB
    United Kingdom

    Site Not Available

  • Doncaster Royal Infirmary

    Doncaster, DN2 5LT
    United Kingdom

    Site Not Available

  • University Hospital North Durham

    Durham, DH1 5TW
    United Kingdom

    Site Not Available

  • South West Acute Hospital

    Enniskillen, BT74 6DN
    United Kingdom

    Site Not Available

  • Royal Devon & Exeter Hospital

    Exeter, EX2 5DW
    United Kingdom

    Site Not Available

  • Frimley Park Hospital

    Frimley, GU16 7UJ
    United Kingdom

    Site Not Available

  • Queen Elizabeth Hospital

    Gateshead, NE9 6SX
    United Kingdom

    Site Not Available

  • Medway Maritime Hospital

    Gillingham, ME7 5NY
    United Kingdom

    Site Not Available

  • Glasgow Royal Infirmary

    Glasgow, G4 0SF
    United Kingdom

    Site Not Available

  • Queen Elizabeth University Hospital

    Glasgow, G51 4TF
    United Kingdom

    Site Not Available

  • Gloucestershire Royal Hospital

    Gloucester, GL1 3NN
    United Kingdom

    Site Not Available

  • Calderdale Royal Hospital

    Halifax, HX3 0PW
    United Kingdom

    Site Not Available

  • Northwick Park

    Harrow, HA1 3UJ
    United Kingdom

    Site Not Available

  • Ystrad Mynach Hospital

    Hengoed, CF82 7EP
    United Kingdom

    Site Not Available

  • Victoria Hospital Kirkcaldy

    Kirkcaldy, KY2 5AH
    United Kingdom

    Site Not Available

  • Royal Lancaster Infirmary

    Lancaster, LA1 4NU
    United Kingdom

    Site Not Available

  • Leeds General Infirmary

    Leeds, LS13EX
    United Kingdom

    Site Not Available

  • Royal Liverpool and Broadgreen University Hospital

    Liverpool, L78XP
    United Kingdom

    Site Not Available

  • University Hospital Aintree

    Liverpool, L9 7 AL
    United Kingdom

    Site Not Available

  • Homerton University Hospital

    London, E9 6SR
    United Kingdom

    Site Not Available

  • North Middlesex University Hospital

    London, N18 1QX
    United Kingdom

    Site Not Available

  • St Thomas Hospital

    London, SE1 7EH
    United Kingdom

    Site Not Available

  • St.George's Hospital

    London, SW17 OQT
    United Kingdom

    Site Not Available

  • The Royal London Hospital

    London, E1 1BB
    United Kingdom

    Site Not Available

  • University College London Hospital

    London, NW1 2BU
    United Kingdom

    Site Not Available

  • Luton & Dunstable University Hospital

    Luton, LU4 0DZ
    United Kingdom

    Site Not Available

  • King's Mill Hospital

    Mansfield, NG17 4JL
    United Kingdom

    Site Not Available

  • James Cook University Hospital

    Middlesbrough, TS4 3BW
    United Kingdom

    Site Not Available

  • Royal Victoria Infirmary

    Newcastle Upon Tyne, NE1 4LP
    United Kingdom

    Site Not Available

  • Nottingham City Hospital

    Nottingham, NG5 1PB
    United Kingdom

    Site Not Available

  • John Radcliffe Hospital

    Oxford, OX3 9DU
    United Kingdom

    Site Not Available

  • Peterborough City Hospital

    Peterborough, PE3 9GZ
    United Kingdom

    Site Not Available

  • Poole Hospital

    Poole, BH15 2JB
    United Kingdom

    Site Not Available

  • Queen Alexandra Hospital

    Portsmouth, PO6 3LY
    United Kingdom

    Site Not Available

  • Royal Preston Hospital

    Preston, PR2 9HT
    United Kingdom

    Site Not Available

  • Royal Berkshire Hospital

    Reading, RG1 5AN
    United Kingdom

    Site Not Available

  • Queen' Hospital Romford

    Romford, RM7 0AG
    United Kingdom

    Site Not Available

  • Salford Royal NHS Foundation Trust

    Salford, M6 8HD
    United Kingdom

    Site Not Available

  • Royal Hallamshire Hospital

    Sheffield, S10 2JF
    United Kingdom

    Site Not Available

  • Southampton General Hospital

    Southampton, SO16 6YD
    United Kingdom

    Site Not Available

  • University Hospital of North Tees

    Stockton-on-Tees, TS19 8PE
    United Kingdom

    Site Not Available

  • Royal Stoke University Hospital

    Stoke-on-Trent, ST4 6QG
    United Kingdom

    Site Not Available

  • Sunderland Royal Hospital

    Sunderland, SR4 7TP
    United Kingdom

    Site Not Available

  • Morriston Hospital

    Swansea, SA6 6NL
    United Kingdom

    Site Not Available

  • The Princess Royal Hospital

    Telford, TF1 6TF
    United Kingdom

    Site Not Available

  • Torbay District General Hospital

    Torquay, TQ2 7AA
    United Kingdom

    Site Not Available

  • Royal Cornwall Hospital

    Truro, TR1 3LJ
    United Kingdom

    Site Not Available

  • Hillingdon Hospital

    Uxbridge, UB8 3NN
    United Kingdom

    Site Not Available

  • Pinderfields Hospital

    Wakefield, WF1 4DG
    United Kingdom

    Site Not Available

  • Southend University Hospital NHS Foundation Trust

    Westcliff-on-Sea, SS0 0RY
    United Kingdom

    Site Not Available

  • Royal Hampshire County Hospital

    Winchester, SO22 5DG
    United Kingdom

    Site Not Available

  • Arrowe Park Hospital

    Wirral, CH49 5EP
    United Kingdom

    Site Not Available

  • New Cross Hospital

    Wolverhampton, WV10 0QP
    United Kingdom

    Site Not Available

  • Yeovil District Hospital

    Yeovil, BA21 4AT
    United Kingdom

    Site Not Available

  • York Hospital

    York, YO31 8HE
    United Kingdom

    Site Not Available

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