Background: Alteplase is the only approved acute drug treatment in ischemic stroke and aims
at dissolving arterial clots causing cerebral ischemia. The overall benefit of alteplase is
substantial. However, there is considerable room for improvement as 2/3 of patients with
large clots may not achieve reopening of the vessel and up to 40% of the patients remain
severely disabled or die.
Tenecteplase, a modified tissue plasminogen activator, has been shown to be a more efficient
and safer thrombolytic drug than alteplase in pre-clinical studies. Tenecteplase has replaced
alteplase as thrombolytic treatment in myocardial infarction and may also be the drug of
choice in ischemic stroke.
Tenecteplase and alteplase had a similar safety profile in the NOR-TEST trial and there were
no differences in efficacy between the two treatment groups. However, a majority of patients
had mild stroke which may be associated with a natural favorable prognosis.
In spite of these neutral results, tenecteplase has the potential to replace alteplase as the
drug of choice, based on a better pharmacological profile and a simpler practical
administration. There is, however, need for a higher number of patients to prove the efficacy
and safety of tenecteplase.
Hypothesis: Tenecteplase 0.4 mg/kg is non-inferior compared with alteplase 0.9 mg/kg.