REstart or STop Antithrombotics Randomised Trial

Not Applicable

Completed

• Conditions: Intracerebral haemorrhage; Circulatory System

• Registration Number: ISRCTN71907627
• Lead Sponsor: niversity of Edinburgh (UK) and NHS Lothian

Brief Summary

2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/29506580 protocol 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31128924 results (added 29/05/2019) 2019 Other publications in https://pubmed.ncbi.nlm.nih.gov/31129065/ subgroup analyses (added 17/02/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34103345/ (added 10/06/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34477823/ Extended Follow-up (added 06/09/2021) 2021 Abstract results in https://doi.org/10.1177/23969873211034932 Results abstract of extended follow-up European Stroke Organisation Conference 2021 (added 29/03/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-04-25
• Study Completion: 2021-02-28
• Last Update Posted: 10 April 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 537

Inclusion Criteria

1. Patient age 18 years or over, either sex
2. Spontaneous intracerebral haemorrhage (ICH) not attributable to preceding traumatic brain injury, on the basis of:
2.1. A history from the patient/witness of spontaneous symptom onset without preceding head trauma (head trauma occurring subsequent to ICH symptom onset is permissible)
2.2. brain imaging appearances consistent with spontaneous ICH (which may be accompanied by the brain/bone/soft tissue appearances of trauma occurring subsequently)
2.3. Either 'secondary' to an underlying structural cause (e.g. aneurysm, tumour, arteriovenous malformation, or intracranial venous thrombosis), or 'primary' (if the investigator either does not suspect an underlying structural cause, or it is not detected by further radiographic investigation)
3. Patient had taken an antithrombotic (i.e. anticoagulant or antiplatelet) drug for the prevention of vaso-occlusive disease for any length of time before the onset of the qualifying ICH.
4. Patient is at least 24 hours after ICH symptom onset (randomisation is expected to usually occur when they are approaching the end of their hospital admission/assessment for the qualifying ICH).
5. Patient and their doctor are both uncertain about whether to start or avoid antiplatelet drugs.
6. Patient is registered with a general practitioner (GP).
7. Brain imaging study that first diagnosed the qualifying ICH is available.
8. Consent to randomisation from the patient (or personal / legal / professional representative if the patient does not have mental capacity).
9. If eligible for the brain MRI sub-study, the MRI must be performed after the ICH but before randomisation.

Exclusion Criteria

1. ICH due to traumatic brain injury, in the opinion of the investigator
2. ICH due to haemorrhagic transformation of an ischaemic stroke, in the opinion of the investigator
3. Patient is taking an anticoagulant drug following ICH
4. Patient is pregnant, breastfeeding, or of childbearing age and not taking contraception
5. Patient is being treated or followed up in another Clinical Trial of an Investigational Medicinal Product (CTIMP)
6. Patient and carer unable to understand spoken or written English (local translator is not available)
7. Patients are ineligible for the brain MRI sub-study if they are claustrophobic or they have a contraindication to MRI

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Current primary outcome measures as of 26/06/2017:<br> 1. Recurrent symptomatic ICH<br> 2. Fatal or non-fatal radiographically- or pathologically-proven recurrent symptomatic<br><br> Measured at least 6 months after baseline, detected using annual general practitioner and participant follow-up, with independent, blinded adjudication of the clinical information and investigations relating to every reported outcome<br><br> Previous primary outcome measures:<br> 1. Recurrent symptomatic ICH<br> 2. Fatal or non-fatal radiographically- or pathologically-proven recurrent symptomatic<br><br> Measured over 2 years after baseline, detected using annual general practitioner and participant follow-up, with independent, blinded adjudication of the clinical information and investigations relating to every reported outcome<br>