AzTrials
AzTrials

Intracranial HemorrhagesPhase 3SoSTARTNCT03153150

Start or STop Anticoagulants Randomised Trial (SoSTART)

A Phase 3 study testing Apixaban, Rivaroxaban and Edoxaban in people with Intracranial Hemorrhages and Intracranial Hemorrhage, Hypertensive, run by University of Edinburgh at 67 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Apixaban, Rivaroxaban and Edoxaban
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
203 participants
Where
67 sitesUnited Kingdom
Study dates
28 Mar 2018to 26 Mar 2021
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 16Show fewer
  • 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

Trial locations and contacts

67 sites in 1 country.

67 sites in 1 country

United Kingdom67 sites

  • Aberdeen Royal Infirmary

    Aberdeen, AB25 2ZN

  • Nevill Hall Hospital

    Abergavenny, NP7 7EG

  • Monklands Hospital

    Airdrie, ML6 0JS

  • Barnet Hospital

    Barnet, EN5 3DJ

  • Royal United Hospital

    Bath, BA1 3NG

  • Heartlands Hospital

    Birmingham, B9 5SS

  • The Royal Bournemouth Hospital

    Bournemouth, BH7 7DW

  • Bradford Royal Infirmary

    Bradford, BD9 6RJ

  • University Hospital Bristol

    Bristol, BS2 8HW

  • Addenbrookes Hospital

    Cambridge, CB2 0QQ

  • University Hospital of Wales/ /University Hospital Llandough

    Cardiff, CF14 4XW

  • Colchester General Hospital

    Colchester, CO4 5JL

  • Derby Royal Hospital

    Derby, DE22 3NE

  • University Hospital North Durham

    Durham, DH1 5TW

  • Edinburgh Royal Infirmary

    Edinburgh, Midlothian, EH16 4SB

  • South West Acute Hospital

    Enniskillen, BT74 6DN

  • Royal Devon & Exeter Hospital

    Exeter, EX2 5DW

  • Frimley Park Hospital

    Frimley, GU16 7UJ

  • Queen Elizabeth Hospital

    Gateshead, NE9 6SX

  • Medway Maritime Hospital

    Gillingham, ME7 5NY

  • Glasgow Royal Infirmary

    Glasgow, G4 0SF

  • Queen Elizabeth University Hospital

    Glasgow, G51 4TF

  • Gloucestershire Royal Hospital

    Gloucester, GL1 3NN

  • Calderdale Royal Hospital

    Halifax, HX3 0PW

  • Northwick Park

    Harrow, HA1 3UJ

  • Ystrad Mynach Hospital

    Hengoed, CF82 7EP

  • Victoria Hospital Kirkcaldy

    Kirkcaldy, KY2 5AH

  • Royal Lancaster Infirmary

    Lancaster, LA1 4NU

  • Leeds General Infirmary

    Leeds, LS13EX

  • Royal Liverpool and Broadgreen University Hospital

    Liverpool, L78XP

  • University Hospital Aintree

    Liverpool, L9 7 AL

  • The Royal London Hospital

    London, E1 1BB

  • Homerton University Hospital

    London, E9 6SR

  • North Middlesex University Hospital

    London, N18 1QX

  • University College London Hospital

    London, NW1 2BU

  • St Thomas Hospital

    London, SE1 7EH

  • St.George's Hospital

    London, SW17 OQT

  • Altnagelvin Hospital

    Londonderry, BT47 6SB

  • Luton & Dunstable University Hospital

    Luton, LU4 0DZ

  • King's Mill Hospital

    Mansfield, NG17 4JL

  • Arrowe Park Hospital

    Metropolitan Borough of Wirral, CH49 5EP

  • James Cook University Hospital

    Middlesbrough, TS4 3BW

  • Royal Victoria Infirmary

    Newcastle upon Tyne, NE1 4LP

  • Nottingham City Hospital

    Nottingham, NG5 1PB

  • John Radcliffe Hospital

    Oxford, OX3 9DU

  • Peterborough City Hospital

    Peterborough, PE3 9GZ

  • Poole Hospital

    Poole, BH15 2JB

  • Royal Preston Hospital

    Preston, PR2 9HT

  • Royal Berkshire Hospital

    Reading, RG1 5AN

  • Queen' Hospital Romford

    Romford, RM7 0AG

  • Salford Royal NHS Foundation Trust

    Salford, M6 8HD

  • Royal Hallamshire Hospital

    Sheffield, S10 2JF

  • Southampton General Hospital

    Southampton, SO16 6YD

  • University Hospital of North Tees

    Stockton-on-Tees, TS19 8PE

  • Royal Stoke University Hospital

    Stoke-on-Trent, ST4 6QG

  • Sunderland Royal Hospital

    Sunderland, SR4 7TP

  • Morriston Hospital

    Swansea, SA6 6NL

  • The Princess Royal Hospital

    Telford, TF1 6TF

  • Torbay District General Hospital

    Torquay, TQ2 7AA

  • Royal Cornwall Hospital

    Truro, TR1 3LJ

  • Hillingdon Hospital

    Uxbridge, UB8 3NN

  • Pinderfields Hospital

    Wakefield, WF1 4DG

  • Southend University Hospital NHS Foundation Trust

    Westcliff-on-Sea, SS0 0RY

  • Royal Hampshire County Hospital

    Winchester, SO22 5DG

  • New Cross Hospital

    Wolverhampton, WV10 0QP

  • Yeovil District Hospital

    Yeovil, BA21 4AT

  • York Hospital

    York, YO31 8HE

Other trials in United Kingdom

About this study

Official title: Start or STop Anticoagulants Randomised Trial (SoSTART) After Spontaneous Intracranial Haemorrhage

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.

Read the 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.

Being tested
Apixaban, Rivaroxaban, Edoxaban, Dabigatran, Acenocoumarol
Keywords
Oral anticoagulant, Factor Xa inhibitors, Direct thrombin inhibitor, Vitamin K antagonist, Antiplatelet drug
Medical subject headings
Intracranial Hemorrhages, Intracranial Hemorrhage, Hypertensive, Subarachnoid Hemorrhage, Hematoma, Subdural, Atrial Fibrillation, Atrial Flutter, Cerebral Small Vessel Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ApixabanDrug

    Also called Eliquis

    The participant will be allocated to start this oral anticoagulant drug, if the participant's doctor indicated it before randomisation.

  • RivaroxabanDrug

    Also called Xarelto

    The participant will be allocated to start this oral anticoagulant drug, if the participant's doctor indicated it before randomisation.

  • EdoxabanDrug

    Also called Lixiana

    The participant will be allocated to start this oral anticoagulant drug, if the participant's doctor indicated it before randomisation.

  • DabigatranDrug

    Also called Pradaxa

    The participant will be allocated to start this oral anticoagulant drug, if the participant's doctor indicated it before randomisation.

  • AcenocoumarolDrug

    Also called Sinthrome

    The participant will be allocated to start this oral anticoagulant drug, if the participant's doctor indicated it before randomisation.

  • PhenindioneDrug

    Also called Dindevan

    The participant will be allocated to start this oral anticoagulant drug, if the participant's doctor indicated it before randomisation.

  • WarfarinDrug

    Also called Marevan, Coumadin

    The participant will be allocated to start this oral anticoagulant drug, if the participant's doctor indicated it before randomisation.

Study groups in NCT03153150
Study groupRoleWhat they receive
Start oral anticoagulant (OAC)ExperimentalIf 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.
Receives: Drug: Apixaban; Drug: Rivaroxaban; Drug: Edoxaban; Drug: Dabigatran; Drug: Acenocoumarol; Drug: Phenindione; Drug: Warfarin
Do not start oral anticoagulant (OAC)No interventionIf 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1 year after trial initiation

  2. 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.

    Measured: 1 year after randomisation

Secondary outcomes (1)

  1. 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.

    Measured: 1 year after randomisation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2017
  2. Study start28 Mar 2018
  3. Primary completion26 Mar 2021
  4. Study completion26 Mar 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
1:1 allocation of intervention: comparator, using a minimisation algorithm
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
203 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03153150
Sponsor's protocol ID
SoSTART2016
Other IDs
2016-004121-16, 2016
Acronym
SoSTART
Status last verified
May 2021
First submitted
10 May 2017
Last updated
8 Apr 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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

Publications

  • 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.

    PubMed 34487722

  • 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.

    PubMed 36700520

  • 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.

    PubMed 34022170

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Apixaban, Rivaroxaban and Edoxaban in people with Intracranial Hemorrhages and Intracranial Hemorrhage, Hypertensive, run by University of Edinburgh at 67 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 67 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The number of participants recruited per site per month (in the pilot phase of the trial) (time frame: 1 year after trial initiation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03153150, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in