Prehospital transdermal glyceryl trinitrate in patients with ultra-acute presumed stroke (RIGHT-2): an ambulance-based, randomised, sham-controlled, blinded, phase 3 trial

Publication date: Available online 6 February 2019Source: The LancetAuthor(s): Philip M Bath, Polly Scutt, Craig S Anderson, Jason P Appleton, Evind Berge, Lesley Cala, Mark Dixon, Timothy M England, Peter J Godolphin, Diane Havard, Lee Haywood, Trish Hepburn, Kailash Krishnan, Grant Mair, Alan A Montgomery, Keith Muir, Stephen J Phillips, Stuart Pocock, John Potter, Chris PriceSummaryBackgroundHigh 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.MethodsWe 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 UK-based 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 out...
Source: The Lancet - Category: General Medicine Source Type: research