Start or STop Anticoagulants Randomised Trial (SoSTART) (SoSTART)

March 31, 2022 updated by: University of Edinburgh

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
203

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Aberdeen, United Kingdom, AB25 2ZN
        • Aberdeen Royal Infirmary
      • Abergavenny, United Kingdom, NP7 7EG
        • Nevill Hall Hospital
      • Airdrie, United Kingdom, ML6 0JS
        • Monklands Hospital
      • Barnet, United Kingdom, EN5 3DJ
        • Barnet Hospital
      • Bath, United Kingdom, BA1 3NG
        • Royal United Hospital
      • Birmingham, United Kingdom, B9 5SS
        • Heartlands Hospital
      • Bournemouth, United Kingdom, BH7 7DW
        • The Royal Bournemouth Hospital
      • Bradford, United Kingdom, BD9 6RJ
        • Bradford Royal Infirmary
      • Bristol, United Kingdom, BS2 8HW
        • University Hospital Bristol
      • Cambridge, United Kingdom, CB2 0QQ
        • Addenbrookes Hospital
      • Cardiff, United Kingdom, CF14 4XW
        • University Hospital of Wales/ /University Hospital Llandough
      • Colchester, United Kingdom, CO4 5JL
        • Colchester General Hospital
      • Derby, United Kingdom, DE22 3NE
        • Derby Royal Hospital
      • Derry, United Kingdom, BT47 6SB
        • Altnagelvin Hospital
      • Durham, United Kingdom, DH1 5TW
        • University Hospital North Durham
      • Enniskillen, United Kingdom, BT74 6DN
        • South West Acute Hospital
      • Exeter, United Kingdom, EX2 5DW
        • Royal Devon & Exeter Hospital
      • Frimley, United Kingdom, GU16 7UJ
        • Frimley Park Hospital
      • Gateshead, United Kingdom, NE9 6SX
        • Queen Elizabeth Hospital
      • Gillingham, United Kingdom, ME7 5NY
        • Medway Maritime Hospital
      • Glasgow, United Kingdom, G4 0SF
        • Glasgow Royal Infirmary
      • Glasgow, United Kingdom, G51 4TF
        • Queen Elizabeth University Hospital
      • Gloucester, United Kingdom, GL1 3NN
        • Gloucestershire Royal Hospital
      • Halifax, United Kingdom, HX3 0PW
        • Calderdale Royal Hospital
      • Harrow, United Kingdom, HA1 3UJ
        • Northwick Park
      • Hengoed, United Kingdom, CF82 7EP
        • Ystrad Mynach Hospital
      • Kirkcaldy, United Kingdom, KY2 5AH
        • Victoria Hospital Kirkcaldy
      • Lancaster, United Kingdom, LA1 4NU
        • Royal Lancaster Infirmary
      • Leeds, United Kingdom, LS13EX
        • Leeds General Infirmary
      • Liverpool, United Kingdom, L78XP
        • Royal Liverpool and Broadgreen University Hospital
      • Liverpool, United Kingdom, L9 7 AL
        • University Hospital Aintree
      • London, United Kingdom, E1 1BB
        • The Royal London Hospital
      • London, United Kingdom, SE1 7EH
        • St Thomas Hospital
      • London, United Kingdom, NW1 2BU
        • University College London Hospital
      • London, United Kingdom, E9 6SR
        • Homerton University Hospital
      • London, United Kingdom, N18 1QX
        • North Middlesex University Hospital
      • London, United Kingdom, SW17 OQT
        • St.George's Hospital
      • Luton, United Kingdom, LU4 0DZ
        • Luton & Dunstable University Hospital
      • Mansfield, United Kingdom, NG17 4JL
        • King's Mill Hospital
      • Middlesbrough, United Kingdom, Ts4 3Bw
        • James Cook University Hospital
      • Newcastle Upon Tyne, United Kingdom, NE1 4LP
        • Royal Victoria Infirmary
      • Nottingham, United Kingdom, NG5 1PB
        • Nottingham City Hospital
      • Oxford, United Kingdom, OX3 9DU
        • John Radcliffe Hospital
      • Peterborough, United Kingdom, PE3 9GZ
        • Peterborough City Hospital
      • Poole, United Kingdom, BH15 2JB
        • Poole Hospital
      • Preston, United Kingdom, PR2 9HT
        • Royal Preston Hospital
      • Reading, United Kingdom, RG1 5AN
        • Royal Berkshire Hospital
      • Romford, United Kingdom, RM7 0AG
        • Queen' Hospital Romford
      • Salford, United Kingdom, M6 8HD
        • Salford Royal NHS Foundation Trust
      • Sheffield, United Kingdom, S10 2JF
        • Royal Hallamshire Hospital
      • Southampton, United Kingdom, SO16 6YD
        • Southampton General Hospital
      • Stockton-on-Tees, United Kingdom, TS19 8PE
        • University Hospital of North Tees
      • Stoke-on-Trent, United Kingdom, ST4 6QG
        • Royal Stoke University Hospital
      • Sunderland, United Kingdom, SR4 7TP
        • Sunderland Royal Hospital
      • Swansea, United Kingdom, SA6 6NL
        • Morriston Hospital
      • Telford, United Kingdom, TF1 6TF
        • The Princess Royal Hospital
      • Torquay, United Kingdom, TQ2 7AA
        • Torbay District General Hospital
      • Truro, United Kingdom, TR1 3LJ
        • Royal Cornwall Hospital
      • Uxbridge, United Kingdom, UB8 3NN
        • Hillingdon Hospital
      • Wakefield, United Kingdom, WF1 4DG
        • Pinderfields Hospital
      • Westcliff-on-Sea, United Kingdom, SS0 0RY
        • Southend University Hospital NHS Foundation Trust
      • Winchester, United Kingdom, SO22 5DG
        • Royal Hampshire County Hospital
      • Wirral, United Kingdom, CH49 5EP
        • Arrowe Park Hospital
      • Wolverhampton, United Kingdom, WV10 0QP
        • New Cross Hospital
      • Yeovil, United Kingdom, BA21 4AT
        • Yeovil District Hospital
      • York, United Kingdom, YO31 8HE
        • York Hospital
    • Midlothian
      • Edinburgh, Midlothian, United Kingdom, EH16 4SB
        • Edinburgh Royal Infirmary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patient age ≥18 years

  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:

  1. Symptomatic intracranial haemorrhage within the last 24 hours (when the risk of haemorrhage expansion/growth is greatest)
  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Drug: Apixaban
The participant will be allocated to start this oral anticoagulant drug, if the participant's doctor indicated it before randomisation.
Other Names:
  • Eliquis
Drug: Rivaroxaban
The participant will be allocated to start this oral anticoagulant drug, if the participant's doctor indicated it before randomisation.
Other Names:
  • Xarelto
Drug: Edoxaban
The participant will be allocated to start this oral anticoagulant drug, if the participant's doctor indicated it before randomisation.
Other Names:
  • Lixiana
Drug: Dabigatran
The participant will be allocated to start this oral anticoagulant drug, if the participant's doctor indicated it before randomisation.
Other Names:
  • Pradaxa
Drug: Acenocoumarol
The participant will be allocated to start this oral anticoagulant drug, if the participant's doctor indicated it before randomisation.
Other Names:
  • Sinthrome
Drug: Phenindione
The participant will be allocated to start this oral anticoagulant drug, if the participant's doctor indicated it before randomisation.
Other Names:
  • Dindevan
Drug: Warfarin
The participant will be allocated to start this oral anticoagulant drug, if the participant's doctor indicated it before randomisation.
Other Names:
  • Marevan
  • Coumadin
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The number of participants recruited per site per month (in the pilot phase of the trial)
Time Frame: 1 year after trial initiation
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.
1 year after trial initiation
Recurrent symptomatic spontaneous intracranial haemorrhage (in the safety phase of the trial)
Time Frame: 1 year after randomisation
~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.
1 year after randomisation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
Time Frame: 1 year after randomisation
The acceptability of the trial protocol to investigators and patients.
1 year after randomisation

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The number of Symptomatic serious vascular events: (in the safety phase of the trial)
Time Frame: 1 year after randomisation
• 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.
1 year after randomisation
The number of Individual symptomatic vascular events: (in the safety phase of the trial)
Time Frame: 1 year after randomisation

  • 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
1 year after randomisation
Annual ratings of participant dependence completed by participant, their carer or nominated contact, or healthcare provider (e.g. general practitioner):
Time Frame: 1 year after randomisation
• Simplified modified Rankin Scale
1 year after randomisation
Ratings of participant quality of life completed by participant, their carer or or nominated contact
Time Frame: Randomisation and 1 year after randomisation
• The 5-level EQ-5D version (EQ-5D-5L) of the EuroQol
Randomisation and 1 year after randomisation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Edinburgh

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
NHS Lothian

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rustam Al-Shahi Salman, MA PhD FRCP, University of Edinburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 28, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 26, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 26, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 10, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 15, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 8, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SoSTART2016
  • 2016-004121-16 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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