Vis enkel innførsel

dc.contributor.authorLogallo, Nicolaen_US
dc.contributor.authorKvistad, Christopher Elnanen_US
dc.contributor.authorNacu, Alionaen_US
dc.contributor.authorNæss, Halvoren_US
dc.contributor.authorWaje-Andreassen, Ulrikeen_US
dc.contributor.authorAsmuss, Jörgen_US
dc.contributor.authorAamodt, Anne Hegeen_US
dc.contributor.authorLund, Christianen_US
dc.contributor.authorKurz, Martinen_US
dc.contributor.authorRønning, Ole Mortenen_US
dc.contributor.authorSalvesen, Rolfen_US
dc.contributor.authorIdicula, Titto T.en_US
dc.contributor.authorThomassen, Larsen_US
dc.date.accessioned2014-10-23T11:37:00Z
dc.date.available2014-10-23T11:37:00Z
dc.date.issued2014-05-15eng
dc.identifier.issn1471-2377
dc.identifier.urihttps://hdl.handle.net/1956/8670
dc.description.abstractBackground: Alteplase is the only approved thrombolytic agent for acute ischaemic stroke. The overall benefit from alteplase is substantial, but some evidence indicates that alteplase also has negative effects on the ischaemic brain. Tenecteplase may be more effective and less harmfull than alteplase, but large randomised controlled phase 3 trials are lacking. The Norwegian Tenecteplase Stroke Trial (NOR-TEST) aims to compare efficacy and safety of tenecteplase vs. alteplase. Methods/Design: NOR-TEST is a multi-centre PROBE (prospective randomised, open-label, blinded endpoint) trial designed to establish superiority of tenecteplase 0.4 mg/kg (single bolus) as compared with alteplase 0.9 mg/kg (10% bolus + 90% infusion/60 minutes) for consecutively admitted patients with acute ischaemic stroke eligible for thrombolytic therapy, i.e. patients a) admitted <4½ hours after symptoms onset; b) admitted <4½ hours after awakening with stroke symptoms c) receiving bridging therapy before embolectomy. Randomisation tenecteplase:alteplase is 1:1. The primary study endpoint is favourable functional outcome defined as modified Rankin Scale 0–1 at 90 days. Secondary study endpoints are: 1) haemorrhagic transformation (haemorrhagic infarct/haematoma); 2) symptomatic cerebral haemorrhage on CT 24–48 hours; 3) major neurological improvement at 24 hours; 4) recanalisation at 24–36 hours; 5) death. Discussion: NOR-TEST may establish a novel approach to acute ischaemic stroke treatment. A positive result will lead to a more effective, safer and easier treatment for all acute ischaemic stroke pasients. NOR-TEST is reviewed and approved by the Regional Committee for Medical and Health Research Ethics (2011/2435), and The Norwegian Medicines Agency (12/01402). NOR-TEST is registered with EudraCT No 2011-005793-33 and in ClinicalTrials.gov (NCT01949948).en_US
dc.language.isoengeng
dc.publisherBioMed Centraleng
dc.rightsAttribution CC BYeng
dc.rights.urihttp://creativecommons.org/licenses/by/4.0eng
dc.subjectAcute ischaemic strokeeng
dc.subjectAlteplaseeng
dc.subjectIntravenous thrombolysiseng
dc.subjectTenecteplaseeng
dc.titleThe Norwegian tenecteplase stroke trial (NOR-TEST): randomised controlled trial of tenecteplase vs. alteplase in acute ischaemic strokeen_US
dc.typePeer reviewed
dc.typeJournal article
dc.date.updated2014-05-21T15:14:57Z
dc.description.versionpublishedVersionen_US
dc.rights.holderNicola Logallo et al.; licensee BioMed Central Ltd.
dc.rights.holderCopyright 2014 Logallo et al.; licensee BioMed Central Ltd
dc.source.articlenumber106
dc.identifier.doihttps://doi.org/10.1186/1471-2377-14-106
dc.identifier.cristin1156298
dc.source.journalBMC Neurology
dc.source.4014


Tilhørende fil(er)

Thumbnail
Thumbnail
Thumbnail

Denne innførselen finnes i følgende samling(er)

Vis enkel innførsel

Attribution CC BY
Med mindre annet er angitt, så er denne innførselen lisensiert som Attribution CC BY