title: The Norwegian tenecteplase stroke trial (NOR-TEST): randomised controlled trial of tenecteplase vs. alteplase in acute ischaemic stroke.
abstract: BACKGROUND
  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
  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.
  
  
  CONCLUSIONS
  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).
authors.affiliation: Center for Neurovascular Diseases, Haukeland University Hospital, Bergen, Norway. nicola.logallo@gmail.com.
authors.forename: Nicola
authors.initials: N
authors.lastname: Logallo
authors.forename: Christopher E
authors.initials: CE
authors.lastname: Kvistad
authors.forename: Aliona
authors.initials: A
authors.lastname: Nacu
authors.forename: Halvor
authors.initials: H
authors.lastname: Naess
authors.forename: Ulrike
authors.initials: U
authors.lastname: Waje-Andreassen
authors.forename: Jörg
authors.initials: J
authors.lastname: Asmuss
authors.forename: Anne Hege
authors.initials: AH
authors.lastname: Aamodt
authors.forename: Christian
authors.initials: C
authors.lastname: Lund
authors.forename: Martin W
authors.initials: MW
authors.lastname: Kurz
authors.forename: Ole Morten
authors.initials: OM
authors.lastname: Rønning
authors.forename: Rolf
authors.initials: R
authors.lastname: Salvesen
authors.forename: Titto T
authors.initials: TT
authors.lastname: Idicula
authors.forename: Lars
authors.initials: L
authors.lastname: Thomassen
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002545:Brain Ischemia / Q000188:drug therapy*; D017128:Embolectomy; D057510:Endovascular Procedures; D005343:Fibrinolytic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008875:Middle Aged; D009664:Norway; D011446:Prospective Studies; D020521:Stroke / Q000188:drug therapy*; D000077785:Tenecteplase; D010959:Tissue Plasminogen Activator / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D005343:Fibrinolytic Agents; D010959:Tissue Plasminogen Activator; D000077785:Tenecteplase