Tenecteplase versus standard care in patients with acute basilar artery occlusion: a multi-centre, prospective, randomised, open-label, blinded endpoint, phase 3, controlled trial

BACKGROUND AND PURPOSE: There is a scarcity of evidence of tenecteplase administered within the 24-hour window of acute ischaemic stroke due to basilar artery occlusion (BAO). We sought to assess whether intravenous tenecteplase within 24 hours of stroke onset, with or without endovascular treatment (EVT), leads to superior outcomes compared with standard care in acute BAO. METHODS AND DESIGN: Tenecteplase Reperfusion therapy in Acute ischaemic Cerebrovascular Events-5 (TRACE-5), using a prospective, randomised, open-label, blinded-endpoint design, will enrol patients with acute ischaemic stroke due to BAO within 24 hours of the time they were last known well. Patients will be randomised to either intravenous tenecteplase (0.25 mg/kg, maximum 25 mg) or standard care. EVT is allowed in both groups. STUDY OUTCOMES: Modified Rankin Scale (mRS) of 0-1 or return to baseline mRS at 90 days is the primary outcome. Secondary outcomes include mRS 0-2 or return to baseline, mRS 0-3 and mRS distribution at 90 days, early neurological improvement within 72 hours and substantial reperfusion at initial angiogram. Safety outcomes are symptomatic intracranial haemorrhage within 36 hours, death within 90 days and mRS 5-6 at 90 days. DISCUSSION: The TRACE-5 trial will address whether extended-time window thrombolysis with a potentially more effective thrombolytic agent tenecteplase±EVT is superior to standard care in BAO. TRIAL REGISTRATION NUMBER: NCT06196320.