Abstract Background and aims In patients with AIS caused by large vessel occlusion (LVO) treated in the extended time window, with CTP selection, better outcomes were obtained with tenecteplase (TNK) versus tPA regarding arterial reperfusion and clinical outcomes. Other studies showed similar results comparing TNK to tPA. None of these trials compared TNK in non-LVO AIS in the extended time window using clinical-radiological mismatch or CTP. Methods To assess the impact in functional outcomes in patients with AIS in 90 days, according to the modified Rankin Score. Results This is a multicenter, randomized, double-blind, placebo-controlled trial enrolling patients with acute ischemic stroke due to distal vessel occlusion between 4.5 and 12 hours from last seen well. Eligible participants, confirmed by clinical-radiological mismatch or perfusion imaging, are randomized 1:1 to receive intravenous tenecteplase (0.25 mg/kg) or standard medical care. Minimization is based on age, baseline NIHSS, treatment window, site, and setting. Conclusions The primary outcome is a favorable functional outcome at 90 days, adjusted for baseline stroke severity. Up to 466 participants will be recruited across Brazilian stroke centers, with interim analyses at 40% and 67% enrollment. Conflict of interest
Silva et al. (Fri,) studied this question.