Ambulance-delivered transdermal glyceryl trinitrate versus sham for ultra-acute stroke: Rationale, design and protocol for the Rapid Intervention with Glyceryl trinitrate in Hypertensive stroke Trial-2 (RIGHT-2) trial (ISRCTN26986053)

Appleton, Jason P.; Scutt, Polly; Dixon, Mark; Howard, Harriet; Haywood, Lee J; Havard, Diane; Hepburn, Trish; England, Timothy J.; Sprigg, Nikola; Woodhouse, Lisa J; Wardlaw, Joanna M.; Montgomery, Alan; Pocock, Stuart J.; Bath, Philip M

doi:10.1177/1747493017724627

Cited by 23 publications

(38 citation statements)

References 65 publications

(98 reference statements)

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“…The Rapid Intervention With Glyceryl Trinitrate in Hypertensive Stroke Trial-2 (RIGHT-2, ISRCTN26986053) will provide further detail on whether the effects of GTN vary between differing stroke etiologies, with imaging markers being key secondary outcomes. 32,33 In addition, the longerterm administration of isosorbide mononitrate (a long-acting nitrate) is being assessed for safety and efficacy in patients with lacunar ischemic stroke and SVD in the ongoing Lacunar Intervention Trial-2 (LACI-2, ISRCTN14911850).…”

Section: Discussionmentioning

confidence: 99%

Imaging markers of small vessel disease and brain frailty, and outcomes in acute stroke

Appleton

Woodhouse

Adami³

et al. 2020

Neurology

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132

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ObjectiveTo assess the association of baseline imaging markers of cerebral small vessel disease (SVD) and brain frailty with clinical outcome after acute stroke in the Efficacy of Nitric Oxide in Stroke (ENOS) trial.MethodsENOS randomized 4,011 patients with acute stroke (<48 hours of onset) to transdermal glyceryl trinitrate (GTN) or no GTN for 7 days. The primary outcome was functional outcome (modified Rankin Scale [mRS] score) at day 90. Cognition was assessed via telephone at day 90. Stroke syndrome was classified with the Oxfordshire Community Stroke Project classification. Brain imaging was adjudicated masked to clinical information and treatment and assessed SVD (leukoaraiosis, old lacunar infarcts/lacunes, atrophy) and brain frailty (leukoaraiosis, atrophy, old vascular lesions/infarcts). Analyses used ordinal logistic regression adjusted for prognostic variables.ResultsIn all participants and those with lacunar syndrome (LACS; 1,397, 34.8%), baseline CT imaging features of SVD and brain frailty were common and independently associated with unfavorable shifts in mRS score at day 90 (all participants: SVD score odds ratio [OR] 1.15, 95% confidence interval [CI] 1.07–1.24; brain frailty score OR 1.25, 95% CI 1.17–1.34; those with LACS: SVD score OR 1.30, 95% CI 1.15–1.47, brain frailty score OR 1.28, 95% CI 1.14–1.44). Brain frailty was associated with worse cognitive scores at 90 days in all participants and in those with LACS.ConclusionsBaseline imaging features of SVD and brain frailty were common in lacunar stroke and all stroke, predicted worse prognosis after all acute stroke with a stronger effect in lacunar stroke, and may aid future clinical decision-making.IdentifierISRCTN99414122.

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Section: Discussionmentioning

confidence: 99%

Imaging markers of small vessel disease and brain frailty, and outcomes in acute stroke

Appleton

Woodhouse

Adami³

et al. 2020

Neurology

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132

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“…Details of the trial design, statistical analysis plan, and baseline data have been published,16, 17, 18 and the design and protocol are summarised in the appendix. The study protocol is available online.…”

Section: Methodsmentioning

confidence: 99%

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

Bath¹,

Scutt²,

Anderson³

et al. 2019

The Lancet

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139

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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.

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“…The efficacy of transdermal GTN given within 4 hours of onset is currently being assessed in the large RIGHT-2 (Rapid Intervention With Glyceryl Trinitrate in Hypertensive Stroke Trial 2). 39…”

Section: Discussionmentioning

confidence: 99%

Effect of Glyceryl Trinitrate on Hemodynamics in Acute Stroke

Appleton

Woodhouse

Bereczki

et al. 2019

Stroke

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Ambulance-delivered transdermal glyceryl trinitrate versus sham for ultra-acute stroke: Rationale, design and protocol for the Rapid Intervention with Glyceryl trinitrate in Hypertensive stroke Trial-2 (RIGHT-2) trial (ISRCTN26986053)

Cited by 23 publications

References 65 publications

Imaging markers of small vessel disease and brain frailty, and outcomes in acute stroke

Imaging markers of small vessel disease and brain frailty, and outcomes in acute stroke

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

Effect of Glyceryl Trinitrate on Hemodynamics in Acute Stroke

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