NOR-TEST tested thrombolytic treatment in acute ischemic stroke with the new drug tenecteplase. NOR-TEST finished the inclusion and Control of patients in December 2016 as planned. A total of 1100 patients from 13 hospitals were included. The study shows that tenecteplase has has a similar safety profile as the commonly used alteplase and also a similar effect as alteplase. The study thus did not reach the aim of demonstrating that tenecteplase was superior to tenecteplase in acute ischemic stroke within the first 4,5 hours after stroke onset. The study is published in The Lancet Neurology 2017 Oct;16(10):781-788.
BACKGROUND: Tenecteplase (TNK)is a modified tPA, which is less cytotoxic, more fibrin-specific and more resistant to inactivation as compared with tPA.
HYPOTHESIS: TNK may be given safely and improves clinical outcome in patients with ischemic stroke as c ompared to tPA.
AIMS: To compare efficacy and safety of TNK 0.4 mg/kg vs tPA 0.9 mg/kg given within 4,5 hours after stroke onset.
DESIGN: Multi-centre PROBE (prospective, randomised, open-label, blinded endpoint) study. Superiority design. Randomisation TNK:tPA = 1:1.
STUDY ENDPOINTS: Primary = functional handicap at 90 days. Secondary = recanalisation and safety (bleedings).
POWER CALCULATION: Aiming to detect 9% higher percentage excellent outcome with TNK vs. tPA(r1=0.40; r2=0.49; OR 1.44; power 0.8) , including 954 patients during 3 years.
BEHANDLING-God og treffsikker diagnostikk, behandling og rehabilitering