Extending the time window for intravenous tenecteplase in patients with distal medium vessel occlusions stroke: study protocol and rationale

BACKGROUND: The TRACE III trial showed that for patients with large arterial occlusion presenting 4.5-24 hours of symptom occurrence and a salvageable penumbra on perfusion imaging, intravenous tenecteplase (TNK) thrombolysis is safe and can significantly improve patient outcomes in cases where endovascular thrombectomy is not feasible. However, it is currently unknown whether intravenous TNK thrombolysis beyond 4.5 hours can improve the outcomes of subjects with distal medium vessel occlusion (MeVO). OBJECTIVE: To determine the safety and effectiveness of extended window TNK thrombolysis for MeVO stroke. METHODS AND DESIGN: Extending the Time Window for Intravenous TNK in Patients with Distal Medium Vessel Occlusions Stroke (TNK-MeVO) is a prospective, randomised, controlled, multicentre and open-label study with blinded outcome assessment. Up to 560 eligible subjects will be randomised 1:1 to receive TNK thrombolysis or standard medical management in over 40 comprehensive stroke centres across China. OUTCOMES: The primary endpoint is the rates of modified Rankin Scale score of 0-1 at 90 days. Safety endpoints include symptomatic intracerebral haemorrhage within 24 hours and mortality at 90 days. CONCLUSIONS: TNK-MeVO trial is designed to provide robust evidence on whether TNK thrombolysis is safe and effective for acute MeVO stroke presenting 4.5-24 hours of symptom onset. TRIAL REGISTRATION NUMBER: NCT06559436.