دورية أكاديمية
Prehospital transdermal glyceryl trinitrate in patients with presumed acute stroke (MR ASAP):an ambulance-based, multicentre, randomised, open-label, blinded endpoint, phase 3 trial
| العنوان: | Prehospital transdermal glyceryl trinitrate in patients with presumed acute stroke (MR ASAP):an ambulance-based, multicentre, randomised, open-label, blinded endpoint, phase 3 trial |
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| المؤلفون: | van den Berg, Sophie A., Uniken Venema, Simone M., Reinink, Hendrik, Hofmeijer, Jeannette, Schonewille, Wouter J., Miedema, Irene, Fransen, Puck S.S., O Pruissen, D. Martijn, Raaijmakers, Theodora W.M., van Dijk, Gert W., de Leeuw, Frank Erik, van Vliet, Jorine A., Kerkhoff, Henk, Esteve Cuevas, Laura M., Visser, Marieke C., Berkhemer, Olvert A., Nieboer, Daan, Lingsma, Hester F., Emmer, Bart J., van der Lugt, Aad, Dippel, Diederik W.J., Versteeg, Adriaan, Nederkoorn, Paul J., Van der Worp, H. Bart |
| المصدر: | van den Berg , S A , Uniken Venema , S M , MR ASAP Investigators , Reinink , H , Hofmeijer , J , Schonewille , W J , Miedema , I , Fransen , P S S , O Pruissen , D M , Raaijmakers , T W M , van Dijk , G W , de Leeuw , F E , van Vliet , J A , Kerkhoff , H , Esteve Cuevas , L M , Visser , M C , Berkhemer , O A , Nieboer , D , Lingsma , H F , .... |
| سنة النشر: | 2022 |
| الوصف: | Background: Pooled analyses of previous randomised studies have suggested that very early treatment with glyceryl trinitrate (also known as nitroglycerin) improves functional outcome in patients with acute ischaemic stroke or intracerebral haemorrhage, but this finding was not confirmed in a more recent trial (RIGHT-2). We aimed to assess whether patients with presumed acute stroke benefit from glyceryl tr initrate started within 3 h after symptom onset. Methods: MR ASAP was a phase 3, randomised, open-label, blinded endpoint trial done at six ambulance services serving 18 hospitals in the Netherlands. Eligible participants (aged ≥18 years) had a probable diagnosis of acute stroke (as assessed by a paramedic), a face-arm-speech-time test score of 2 or 3, systolic blood pressure of at least 140 mm Hg, and could start treatment within 3 h of symptom onset. Participants were randomly assigned (1:1) by ambulance personnel, using a secure web-based electronic application with random block sizes stratified by ambulance service, to receive either transdermal glyceryl trinitrate 5 mg/day for 24 h plus standard care (glyceryl trinitrate group) or to standard care alone (control group) in the prehospital setting. Informed consent was deferred until after arrival at the hospital. The primary outcome was functional outcome assessed with the modified Rankin Scale (mRS) at 90 days. Safety outcomes included death within 7 days, death within 90 days, and serious adverse events. Analyses were based on modified intention to treat, and treatment effects were expressed as odds ratios (ORs) or common ORs, with adjustment for baseline prognostic factors. We separately analysed the total population and the target population (ie, patients with intracerebral haemorrhage, ischaemic stroke, or transient ischaemic attack). The target sample size was 1400 patients. The trial is registered as ISRCTN99503308. Findings: On June 24, 2021, the MR ASAP trial was prematurely terminated on the advice of the data and safety monitoring board, with ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| العلاقة: | https://pure.eur.nl/en/publications/aa48bbc6-48d1-4c78-bb90-7b03e0da8b63Test |
| DOI: | 10.1016/S1474-4422(22)00333-7 |
| الإتاحة: | https://doi.org/10.1016/S1474-4422Test(22)00333-7 https://pure.eur.nl/en/publications/aa48bbc6-48d1-4c78-bb90-7b03e0da8b63Test http://www.scopus.com/inward/record.url?scp=85140052288&partnerID=8YFLogxKTest https://hdl.handle.net/11370/4be8e5ea-ce73-44cc-9467-53e548a0319eTest |
| حقوق: | info:eu-repo/semantics/openAccess |
| رقم الانضمام: | edsbas.9EC423E8 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1016/S1474-4422(22)00333-7 |
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