Background: High blood pressure (BP) is common in acute stroke and associated with a worse functional outcome. Glyceryl trinitrate (GTN), a nitric oxide donor, lowers BP in acute stroke and may improve outcome.
Aims: RIGHT-2 tested the feasibility of performing a UK multicentre ambulance-based stroke trial, and the safety and efficacy of GTN when administered by paramedics before hospital admission.
Methods: Paramedic-led ambulance-based multi-centre prospective randomised single-blind blinded-endpoint parallel-group controlled trial of transdermal GTN (given for 4 days) versus sham in patients with ultra-acute (less than 4 hours) presumed stroke. Data are number (%), median [interquartile range] or mean (standard deviation).
Results: Recruitment ran from October 2015 to 31st May 2018. 1,149 patients were recruited from 8 UK Ambulance Services and taken to 54 acute hospitals. Baseline characteristics include: mean age 73 (15) years; female 555 (48%); median time from stroke to randomisation 70 [45, 115] minutes; Face-Arm-Speech scale score 2.6 (0.5); and blood pressure 162 (25)/92 (18) mmHg. The final diagnosis was ischaemic stroke 52%, haemorrhagic stroke 13%, TIA 9%, and mimic 25%. The main trial results will be presented in quarter 4 2018. The results will also be included in updated Cochrane systematic reviews, and individual patient data meta-analyses of all relevant randomised controlled trials.
Conclusion: It was feasible to perform a multicentre ambulance-based ultra-acute stroke trial in the UK, and to treat with GTN versus sham. The relatively unselected cohort of stroke patients is broadly representative of those admitted to hospital in the UK.