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Open Access Study protocol

The Norwegian tenecteplase stroke trial (NOR-TEST): randomised controlled trial of tenecteplase vs. alteplase in acute ischaemic stroke

Nicola Logallo12*, Christopher E Kvistad12, Aliona Nacu12, Halvor Naess13, Ulrike Waje-Andreassen12, Jörg Asmuss4, Anne Hege Aamodt5, Christian Lund5, Martin W Kurz6, Ole Morten Rønning7, Rolf Salvesen89, Titto T Idicula10 and Lars Thomassen12

Author Affiliations

1 Center for Neurovascular Diseases, Haukeland University Hospital, Bergen, Norway

2 Department of Clinical Medicine, University of Bergen, Bergen, Norway

3 Centre for Age-related Medicine, Stavanger University Hospital, Stavanger, Norway

4 Centre for Clinical Research, Haukeland University Hospital, Bergen, Norway

5 Department of Neurology, Oslo University Hospital, Rikshospitalet, Norway

6 Department of Neurology, Stavanger University Hospital, Stavanger, Norway

7 Medical Division, Department of Neurology, Akershus University Hospital, Lørenskog, Norway

8 Department of Neurology, Nordland Hospital, Bodo, Norway

9 Department of Clinical Medicine, University of Tromso, Norway

10 Department of Neurology, St.Olav Hospital, Trondheim, Norway

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BMC Neurology 2014, 14:106  doi:10.1186/1471-2377-14-106

Published: 15 May 2014

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/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).

Keywords:
Acute ischaemic stroke; Alteplase; Intravenous thrombolysis; Tenecteplase