Overview

Start or STop Anticoagulants Randomised Trial (SoSTART)

Status:
Completed
Trial end date:
2021-03-26
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Edinburgh
Collaborator:
NHS Lothian
Treatments:
Acenocoumarol
Anticoagulants
Antithrombins
Apixaban
Dabigatran
Edoxaban
Factor Xa Inhibitors
Phenindione
Platelet Aggregation Inhibitors
Rivaroxaban
Warfarin
Criteria
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