Back to resultsStart or STop Anticoagulants Randomised Trial (SoSTART) (SoSTART)
Primary Purpose
Intracranial Hemorrhages, Intracranial Hemorrhage, Hypertensive, Subarachnoid Hemorrhage
Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
Apixaban
Rivaroxaban
Edoxaban
Dabigatran
Acenocoumarol
Phenindione
Warfarin
Sponsored by
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
Arm Type
Experimental
No Intervention
Arm Label
Start oral anticoagulant (OAC)
Do not start oral anticoagulant (OAC)
Arm Description
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.
Outcomes
Primary Outcome Measures
The number of participants recruited per site per month (in the pilot phase of the trial)
The rate of recruiting up to 60 participants to determine the feasibility of recruiting the target sample size in the main phase of the trial in an acceptable timescale.
Recurrent symptomatic spontaneous intracranial haemorrhage (in the safety phase of the trial)
~60 hospital sites will recruit at least 190 participants to determine whether the risk of recurrent symptomatic intracranial haemorrhage is sufficiently low (non-inferior) to justify a definitive trial.
Secondary Outcome Measures
The proportions of all eligible patients recorded on screening logs who are recruited, unsuitable, or decline to participate (in the pilot phase of the trial)
The acceptability of the trial protocol to investigators and patients.
Full Information
NCT ID
NCT03153150
First Posted
May 10, 2017
Last Updated
March 31, 2022
Sponsor
University of Edinburgh
Collaborators
NHS Lothian
1. Study Identification
Unique Protocol Identification Number
NCT03153150
Brief Title
Start or STop Anticoagulants Randomised Trial (SoSTART)
Acronym
SoSTART
Official Title
Start or STop Anticoagulants Randomised Trial (SoSTART) After Spontaneous Intracranial Haemorrhage
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
March 28, 2018 (Actual)
Primary Completion Date
March 26, 2021 (Actual)
Study Completion Date
March 26, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Edinburgh
Collaborators
NHS Lothian
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Hemorrhages, Intracranial Hemorrhage, Hypertensive, Subarachnoid Hemorrhage, Subdural Hematoma, Intraventricular Hemorrhage, Atrial Fibrillation, Atrial Flutter, Small Vessel Cerebrovascular Disease, Microhaemorrhage
Keywords
Oral anticoagulant, Factor Xa inhibitors, Direct thrombin inhibitor, Vitamin K antagonist, Antiplatelet drug
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
1:1 allocation of intervention: comparator, using a minimisation algorithm
Masking
Outcomes Assessor
Masking Description
PROBE design
Allocation
Randomized
Enrollment
203 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Start oral anticoagulant (OAC)
Arm Type
Experimental
Arm Description
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.
Arm Title
Do not start oral anticoagulant (OAC)
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Apixaban
Other Intervention Name(s)
Eliquis
Intervention Description
The participant will be allocated to start this oral anticoagulant drug, if the participant's doctor indicated it before randomisation.
Intervention Type
Drug
Intervention Name(s)
Rivaroxaban
Other Intervention Name(s)
Xarelto
Intervention Description
The participant will be allocated to start this oral anticoagulant drug, if the participant's doctor indicated it before randomisation.
Intervention Type
Drug
Intervention Name(s)
Edoxaban
Other Intervention Name(s)
Lixiana
Intervention Description
The participant will be allocated to start this oral anticoagulant drug, if the participant's doctor indicated it before randomisation.
Intervention Type
Drug
Intervention Name(s)
Dabigatran
Other Intervention Name(s)
Pradaxa
Intervention Description
The participant will be allocated to start this oral anticoagulant drug, if the participant's doctor indicated it before randomisation.
Intervention Type
Drug
Intervention Name(s)
Acenocoumarol
Other Intervention Name(s)
Sinthrome
Intervention Description
The participant will be allocated to start this oral anticoagulant drug, if the participant's doctor indicated it before randomisation.
Intervention Type
Drug
Intervention Name(s)
Phenindione
Other Intervention Name(s)
Dindevan
Intervention Description
The participant will be allocated to start this oral anticoagulant drug, if the participant's doctor indicated it before randomisation.
Intervention Type
Drug
Intervention Name(s)
Warfarin
Other Intervention Name(s)
Marevan, Coumadin
Intervention Description
The participant will be allocated to start this oral anticoagulant drug, if the participant's doctor indicated it before randomisation.
Primary Outcome Measure Information:
Title
The number of participants recruited per site per month (in the pilot phase of the trial)
Description
The rate of recruiting up to 60 participants to determine the feasibility of recruiting the target sample size in the main phase of the trial in an acceptable timescale.
Time Frame
1 year after trial initiation
Title
Recurrent symptomatic spontaneous intracranial haemorrhage (in the safety phase of the trial)
Description
~60 hospital sites will recruit at least 190 participants to determine whether the risk of recurrent symptomatic intracranial haemorrhage is sufficiently low (non-inferior) to justify a definitive trial.
Time Frame
1 year after randomisation
Secondary Outcome Measure Information:
Title
The proportions of all eligible patients recorded on screening logs who are recruited, unsuitable, or decline to participate (in the pilot phase of the trial)
Description
The acceptability of the trial protocol to investigators and patients.
Time Frame
1 year after randomisation
Other Pre-specified Outcome Measures:
Title
The number of Symptomatic serious vascular events: (in the safety phase of the trial)
Description
• All symptomatic serious vascular events (i.e. major adverse cardiac or cerebrovascular events [MACCE]) including: non-fatal (i.e. not followed by death within 30 days of onset) myocardial infarction; stroke (i.e. ischaemic, haemorrhagic, unknown sub-type) or spontaneous subdural haemorrhage; or death from a vascular cause (i.e. haemorrhagic or ischaemic events followed by death within 30 days), sudden death, or death of an unknown cause.
Time Frame
1 year after randomisation
Title
The number of Individual symptomatic vascular events: (in the safety phase of the trial)
Description
Major haemorrhagic events (Bleeding Academic Research Consortium types 3-5)
Recurrent symptomatic spontaneous intracranial haemorrhage
Extracranial haemorrhage
Symptomatic ischaemic events
ischaemic stroke
myocardial infarction
peripheral arterial occlusion
mesenteric ischaemia
central retinal arterial occlusion
deep vein thrombosis
pulmonary embolism
cardiac death with symptoms suggestive of myocardial ischaemia (type 3),or evidence of arrhythmia
Revascularisation procedures (carotid, coronary, or peripheral arterial)
Symptomatic stroke of uncertain sub-type
Non-fatal stroke, with brain imaging performed too late to distinguish haemorrhage from infarction
Rapidly fatal stroke, but without radiographic or pathological confirmation
Time Frame
1 year after randomisation
Title
Annual ratings of participant dependence completed by participant, their carer or nominated contact, or healthcare provider (e.g. general practitioner):
Description
• Simplified modified Rankin Scale
Time Frame
1 year after randomisation
Title
Ratings of participant quality of life completed by participant, their carer or or nominated contact
Description
• The 5-level EQ-5D version (EQ-5D-5L) of the EuroQol
Time Frame
Randomisation and 1 year after randomisation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rustam Al-Shahi Salman, MA PhD FRCP
Organizational Affiliation
University of Edinburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Edinburgh Royal Infirmary
City
Edinburgh
State/Province
Midlothian
ZIP/Postal Code
EH16 4SB
Country
United Kingdom
Facility Name
Aberdeen Royal Infirmary
City
Aberdeen
ZIP/Postal Code
AB25 2ZN
Country
United Kingdom
Facility Name
Nevill Hall Hospital
City
Abergavenny
ZIP/Postal Code
NP7 7EG
Country
United Kingdom
Facility Name
Monklands Hospital
City
Airdrie
ZIP/Postal Code
ML6 0JS
Country
United Kingdom
Facility Name
Barnet Hospital
City
Barnet
ZIP/Postal Code
EN5 3DJ
Country
United Kingdom
Facility Name
Royal United Hospital
City
Bath
ZIP/Postal Code
BA1 3NG
Country
United Kingdom
Facility Name
Heartlands Hospital
City
Birmingham
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
The Royal Bournemouth Hospital
City
Bournemouth
ZIP/Postal Code
BH7 7DW
Country
United Kingdom
Facility Name
Bradford Royal Infirmary
City
Bradford
ZIP/Postal Code
BD9 6RJ
Country
United Kingdom
Facility Name
University Hospital Bristol
City
Bristol
ZIP/Postal Code
BS2 8HW
Country
United Kingdom
Facility Name
Addenbrookes Hospital
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
University Hospital of Wales/ /University Hospital Llandough
City
Cardiff
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
Facility Name
Colchester General Hospital
City
Colchester
ZIP/Postal Code
CO4 5JL
Country
United Kingdom
Facility Name
Derby Royal Hospital
City
Derby
ZIP/Postal Code
DE22 3NE
Country
United Kingdom
Facility Name
Altnagelvin Hospital
City
Derry
ZIP/Postal Code
BT47 6SB
Country
United Kingdom
Facility Name
University Hospital North Durham
City
Durham
ZIP/Postal Code
DH1 5TW
Country
United Kingdom
Facility Name
South West Acute Hospital
City
Enniskillen
ZIP/Postal Code
BT74 6DN
Country
United Kingdom
Facility Name
Royal Devon & Exeter Hospital
City
Exeter
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Facility Name
Frimley Park Hospital
City
Frimley
ZIP/Postal Code
GU16 7UJ
Country
United Kingdom
Facility Name
Queen Elizabeth Hospital
City
Gateshead
ZIP/Postal Code
NE9 6SX
Country
United Kingdom
Facility Name
Medway Maritime Hospital
City
Gillingham
ZIP/Postal Code
ME7 5NY
Country
United Kingdom
Facility Name
Glasgow Royal Infirmary
City
Glasgow
ZIP/Postal Code
G4 0SF
Country
United Kingdom
Facility Name
Queen Elizabeth University Hospital
City
Glasgow
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Facility Name
Gloucestershire Royal Hospital
City
Gloucester
ZIP/Postal Code
GL1 3NN
Country
United Kingdom
Facility Name
Calderdale Royal Hospital
City
Halifax
ZIP/Postal Code
HX3 0PW
Country
United Kingdom
Facility Name
Northwick Park
City
Harrow
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom
Facility Name
Ystrad Mynach Hospital
City
Hengoed
ZIP/Postal Code
CF82 7EP
Country
United Kingdom
Facility Name
Victoria Hospital Kirkcaldy
City
Kirkcaldy
ZIP/Postal Code
KY2 5AH
Country
United Kingdom
Facility Name
Royal Lancaster Infirmary
City
Lancaster
ZIP/Postal Code
LA1 4NU
Country
United Kingdom
Facility Name
Leeds General Infirmary
City
Leeds
ZIP/Postal Code
LS13EX
Country
United Kingdom
Facility Name
Royal Liverpool and Broadgreen University Hospital
City
Liverpool
ZIP/Postal Code
L78XP
Country
United Kingdom
Facility Name
University Hospital Aintree
City
Liverpool
ZIP/Postal Code
L9 7 AL
Country
United Kingdom
Facility Name
The Royal London Hospital
City
London
ZIP/Postal Code
E1 1BB
Country
United Kingdom
Facility Name
Homerton University Hospital
City
London
ZIP/Postal Code
E9 6SR
Country
United Kingdom
Facility Name
North Middlesex University Hospital
City
London
ZIP/Postal Code
N18 1QX
Country
United Kingdom
Facility Name
University College London Hospital
City
London
ZIP/Postal Code
NW1 2BU
Country
United Kingdom
Facility Name
St Thomas Hospital
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Facility Name
St.George's Hospital
City
London
ZIP/Postal Code
SW17 OQT
Country
United Kingdom
Facility Name
Luton & Dunstable University Hospital
City
Luton
ZIP/Postal Code
LU4 0DZ
Country
United Kingdom
Facility Name
King's Mill Hospital
City
Mansfield
ZIP/Postal Code
NG17 4JL
Country
United Kingdom
Facility Name
James Cook University Hospital
City
Middlesbrough
ZIP/Postal Code
TS4 3BW
Country
United Kingdom
Facility Name
Royal Victoria Infirmary
City
Newcastle Upon Tyne
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Facility Name
Nottingham City Hospital
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
John Radcliffe Hospital
City
Oxford
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Facility Name
Peterborough City Hospital
City
Peterborough
ZIP/Postal Code
PE3 9GZ
Country
United Kingdom
Facility Name
Poole Hospital
City
Poole
ZIP/Postal Code
BH15 2JB
Country
United Kingdom
Facility Name
Royal Preston Hospital
City
Preston
ZIP/Postal Code
PR2 9HT
Country
United Kingdom
Facility Name
Royal Berkshire Hospital
City
Reading
ZIP/Postal Code
RG1 5AN
Country
United Kingdom
Facility Name
Queen' Hospital Romford
City
Romford
ZIP/Postal Code
RM7 0AG
Country
United Kingdom
Facility Name
Salford Royal NHS Foundation Trust
City
Salford
ZIP/Postal Code
M6 8HD
Country
United Kingdom
Facility Name
Royal Hallamshire Hospital
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
University Hospital of North Tees
City
Stockton-on-Tees
ZIP/Postal Code
TS19 8PE
Country
United Kingdom
Facility Name
Royal Stoke University Hospital
City
Stoke-on-Trent
ZIP/Postal Code
ST4 6QG
Country
United Kingdom
Facility Name
Sunderland Royal Hospital
City
Sunderland
ZIP/Postal Code
SR4 7TP
Country
United Kingdom
Facility Name
Morriston Hospital
City
Swansea
ZIP/Postal Code
SA6 6NL
Country
United Kingdom
Facility Name
The Princess Royal Hospital
City
Telford
ZIP/Postal Code
TF1 6TF
Country
United Kingdom
Facility Name
Torbay District General Hospital
City
Torquay
ZIP/Postal Code
TQ2 7AA
Country
United Kingdom
Facility Name
Royal Cornwall Hospital
City
Truro
ZIP/Postal Code
TR1 3LJ
Country
United Kingdom
Facility Name
Hillingdon Hospital
City
Uxbridge
ZIP/Postal Code
UB8 3NN
Country
United Kingdom
Facility Name
Pinderfields Hospital
City
Wakefield
ZIP/Postal Code
WF1 4DG
Country
United Kingdom
Facility Name
Southend University Hospital NHS Foundation Trust
City
Westcliff-on-Sea
ZIP/Postal Code
SS0 0RY
Country
United Kingdom
Facility Name
Royal Hampshire County Hospital
City
Winchester
ZIP/Postal Code
SO22 5DG
Country
United Kingdom
Facility Name
Arrowe Park Hospital
City
Wirral
ZIP/Postal Code
CH49 5EP
Country
United Kingdom
Facility Name
New Cross Hospital
City
Wolverhampton
ZIP/Postal Code
WV10 0QP
Country
United Kingdom
Facility Name
Yeovil District Hospital
City
Yeovil
ZIP/Postal Code
BA21 4AT
Country
United Kingdom
Facility Name
York Hospital
City
York
ZIP/Postal Code
YO31 8HE
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The Chief Investigator (Prof. Rustam Al-Shahi Salman) has established the Collaboration Of Controlled Randomised trials of Oral Antithrombotic drugs after intraCranial Haemorrhage (COCROACH) working towards a pre-planned individual patient data meta-analysis
Citations:
PubMed Identifier
34487722
Citation
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.
Results Reference
result
PubMed Identifier
34022170
Citation
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. Erratum In: Lancet Neurol. 2021 Jun 9;:
Results Reference
derived
Links:
URL
http://www.sostart.ed.ac.uk
Description
Trial website
URL
http://www.rush.ed.ac.uk
Description
Chief investigator details
Learn more about this trial
Start or STop Anticoagulants Randomised Trial (SoSTART)
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