A landmark stroke thrombolysis study has backed new Australian recommendations for tenecteplase to be use as an alternative to alteplase within 4.5 hours of stroke onset.
The Canadian AcT study is the first randomised controlled trial to provide solid evidence that tenecteplase 0·25 mg/kg is equally safe and effective as alteplase 0·9 mg/kg in patients with acute ischaemic stroke, according to international stroke researchers writing in The Lancet.
They said findings should be practice changing because tenecteplase may be administered as a single immediate dose whereas alteplase delivery takes up to an hour and requires an infusion pump that needs to be monitored, a major drawback when transporting a patient.
The study was a pragmatic, multicentre, open-label trial comparing tenecteplase with alteplase in 1577 patients with acute ischaemic stroke presenting within 4·5 hours of symptom onset.
Conducted across 22 stroke centres, the study showed that for the primary endpoint of excellent functional outcome (modified Rankin Scale score of 0–1) at 90–120 days, tenecteplase treatment was non-inferior to alteplase ( (36·9% vs 34·8%).
There were also no differences between the treatment groups in the secondary efficacy endpoints, such as return to baseline function at 90 days, door-to-needle time, proportion of patients given endovascular therapy, cognition and length of hospital stay.
Likewise the two treatments showed no differences in safety endpoints, with 3·4% patients in the tenecteplase group and 3·2% in the alteplase group had 24 hour symptomatic intracerebral haemorrhage and 15·3% vs 15·4% died within 90 days of starting treatment.