Background High blood pressure is common in acute stroke and is a predictor of poor outcome; however, large trials of lowering blood pressure have given variable results, and the management of high blood pressure in ultra-acute stroke remains unclear. We investigated whether transdermal glyceryl trinitrate (GTN; also known as nitroglycerin), a nitric oxide donor, might improve outcome when administered very early after stroke onset. Methods We did a multicentre, paramedic-delivered, ambulance-based, prospective, randomised, sham-controlled, blinded-endpoint, phase 3 trial in adults with presumed stroke within 4 h of onset, face-arm-speech-time score of 2 or 3, and systolic blood pressure 120 mm Hg or higher. Participants were randomly assigned (1:1) to receive transdermal GTN (5 mg once daily for 4 days; the GTN group) or a similar sham dressing (the sham group) in UKbased ambulances by paramedics, with treatment continued in hospital. Paramedics were unmasked to treatment, whereas participants were masked. The primary outcome was the 7-level modified Rankin Scale (mRS; a measure of functional outcome) at 90 days, assessed by central telephone follow-up with masking to treatment. Analysis was hierarchical, first in participants with a confirmed stroke or transient ischaemic attack (cohort 1), and then in all participants who were randomly assigned (intention to treat, cohort 2) according to the statistical analysis plan. This trial is registered with ISRCTN, number ISRCTN26986053.

Summary Background Antiplatelet therapy reduces the risk of major vascular events for people with occlusive vascular disease, although it might increase the risk of intracranial haemorrhage. Patients surviving the commonest subtype of intracranial haemorrhage, intracerebral haemorrhage, are at risk of both haemorrhagic and occlusive vascular events, but whether antiplatelet therapy can be used safely is unclear. We aimed to estimate the relative and absolute effects of antiplatelet therapy on recurrent intracerebral haemorrhage and whether this risk might exceed any reduction of occlusive vascular events. Methods The REstart or STop Antithrombotics Randomised Trial (RESTART) was a prospective, randomised, open-label, blinded endpoint, parallel-group trial at 122 hospitals in the UK. We recruited adults (≥18 years) who were taking antithrombotic (antiplatelet or anticoagulant) therapy for the prevention of occlusive vascular disease when they developed intracerebral haemorrhage, discontinued antithrombotic therapy, and survived for 24 h. Computerised randomisation incorporating minimisation allocated participants (1:1) to start or avoid antiplatelet therapy. We followed participants for the primary outcome (recurrent symptomatic intracerebral haemorrhage) for up to 5 years. We analysed data from all randomised participants using Cox proportional hazards regression, adjusted for minimisation covariates. This trial is registered with ISRCTN (number ISRCTN71907627). Findings Between May 22, 2013, and May 31, 2018, 537 participants were recruited a median of 76 days (IQR 29–146) after intracerebral haemorrhage onset: 268 were assigned to start and 269 (one withdrew) to avoid antiplatelet therapy. Participants were followed for a median of 2·0 years (IQR [1·0– 3·0]; completeness 99·3%). 12 (4%) of 268 participants allocated to antiplatelet therapy had recurrence of intracerebral haemorrhage compared with 23 (9%) of 268 participants allocated to avoid antiplatelet therapy (adjusted hazard ratio 0·51 [95% CI 0·25–1·03]; p=0·060). 18 (7%) participants allocated to antiplatelet therapy experienced major haemorrhagic events compared with 25 (9%) participants allocated to avoid antiplatelet therapy (0·71 [0·39–1·30]; p=0·27), and 39 [15%] participants allocated to antiplatelet therapy had major occlusive vascular events compared with 38 [14%] allocated to avoid antiplatelet therapy (1·02 [0·65–1·60]; p=0·92). Interpretation These results exclude all but a very modest increase in the risk of recurrent intracerebral haemorrhage with antiplatelet therapy for patients on antithrombotic therapy for the prevention of occlusive vascular disease when they developed intracerebral haemorrhage. The risk of recurrent intracerebral haemorrhage is probably too small to exceed the established benefits of antiplatelet therapy for secondary prevention. Funding British Heart Foundation.

No abstract

Background Findings from the RESTART trial suggest that starting antiplatelet therapy might reduce the risk of recurrent symptomatic intracerebral haemorrhage compared with avoiding antiplatelet therapy. Brain imaging features of intracerebral haemorrhage and cerebral small vessel diseases (such as cerebral microbleeds) are associated with greater risks of recurrent intracerebral haemorrhage. We did subgroup analyses of the RESTART trial to explore whether these brain imaging features modify the effects of antiplatelet therapy. Methods RESTART was a prospective, randomised, open-label, blinded-endpoint, parallel-group trial at 122 hospitals in the UK that assessed whether starting antiplatelet therapy might reduce the risk of recurrent symptomatic intracerebral haemorrhage compared with avoiding antiplatelet therapy. For this prespecified subgroup analysis, consultant neuroradiologists masked to treatment allocation reviewed brain CT or MRI scans performed before randomisation to confirm participant eligibility and rate features of the intracerebral haemorrhage and surrounding brain. We followed participants for primary (recurrent symptomatic intracerebral haemorrhage) and secondary (ischaemic stroke) outcomes for up to 5 years (reported elsewhere). For this report, we analysed eligible participants with intracerebral haemorrhage according to their treatment allocation in primary subgroup analyses of cerebral microbleeds on MRI and in exploratory subgroup analyses of other features on CT or MRI. The trial is registered with the ISRCTN registry, number ISRCTN71907627.

S The Assessment of Communicative Effectiveness in Severe Aphasia (ACESA) was developed to measure the communicative effectiveness of people with severe aphasia following a stroke. The reliability was evaluated. Ten patients with severe communication difficulties (particularly limited expression) were assessed and videoed. The videos were rated by three trained raters. Reliability was calculated to demonstrate intrarater and interrater reliability, and test–re‐test reliability. Reliability was good but needed to be improved across raters. It was concluded that the ACESA has the potential to be a useful clinical and research tool. L'évaluation de l'efficacité communicative lors d'aphasie sévère (abréviation anglaise: ACESA) a été mise au point afin de mesurer l'efficacité communicative de personnes atteintes d'aphasie sévère par suite d'une attaque. L'on a mesuré la fiabilité de ce procédé. Dix patients souffrant de difficultés sévères de communication (en particulier de possibilités limitées d'expression) ont été évalués et enregistrés sur vidéos. Trois experts ont procédé au classement de ces vidéos. La fiabilité a été calculée de telle façon qu'elle démontrait une régularité chez un me̊me expert, une régularité d'expert à expert et une régularité quand le me̊me test était administré de façon répe̊tée. La fiabilité s'est révélée bonne mais avait besoin d'e̊tre améliorée en ce qui concernait la comparaison entre les experts. L'on conclut que l'évaluation de l'efficacité communicative lors d'aphasie sévère a la capacité d'e̊tre un outil utile de traitement clinique et de recherche. Das ACESA‐Verfahren (Assessment of Communication Effectiveness in Severe Aphasia = Evaluierung der Kommunikationswirksamkeit bei schwerer Aphasie) wurde entwickelt, um die Kommunikationsfähigkeit aphatischer Menschen nach schwerem Hirnschlag zu messen. Die Reliabilität wurde geprüft. Zehn Patienten mit schwerwiegenden Kommunikationsproblemen (insbesondere begrenzte Ausdrucksfähigkeit) wurden dem Verfahren unterzogen und dabei auf Video aufgezeichnet. Die Videos wurden von drei geschulten Bewertem beurteilt. Inter‐ und Intrabewert‐erreliabilität und Testwiederholungs‐reliabilität wurden berechnet. Die Reliabilität war gut, bedarf jedoch der Verbesserung zwischen Bewertern. Es wird konstatiert, daßta ACESA für klinische Zwecke und in der Forschung ein potentiell nützliches Verfahren darstellt.