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Alteplase is currently the only FDA-approved thrombolytic medication for acute stroke. Tenecteplase is a bioengineered compound with greater fibrin specificity and a longer half-life than alteplase. A small, multicenter, phase 2 trial (NEJM JW Neurol Mar 2012) showed higher rates of reperfusion and improved clinical outcome with tenecteplase than with alteplase.
In this multicenter, phase 3 trial, 1100 adults with suspected acute ischemic stroke at 13 centers in Norway were randomly assigned to receive either tenecteplase (0.4 mg/kg up to a maximum of 40 mg) or alteplase (0.9 mg/kg up to a maximum of 90 mg). Patients were eligible if they could be treated within 4.5 hours of either stroke onset or awakening with symptoms. The primary outcome…