Tenecteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-BEYOND--A Multicenter, Prospective, Randomized, Open Label, Blinded-endpoint (PROBE) Controlled Trial of Tenecteplase Versus Standard Medical Treatment for Acute Ischemic Stroke Due to Large Vessel Occlusion With Perfusion Mismatch 24 to 72 Hours of Symptom Onset
The benefit-risk profile of thrombolysis for acute ischemic strokes beyond 24 hours has never been investigated. We initiated a multicenter, prospective, randomized, open label, blinded-endpoint (PROBE) controlled trial to assess the safety and efficacy of tenecteplase (0.25mg/kg, max 25mg) versus standard medical treatment in acute ischemic stroke due to large vessel occlusion between 24-72 hours of symptom onset (including wake-up stroke and unwitnessed stroke).
• Age ≥ 18 years old;
• Acute ischemic stroke symptom onset between 24 to 72 hours prior to enrollment; including wake-up stroke and unwitnessed stroke, onset time refers to 'last-seen normal time';
• Pre-stroke modified Rankin scale (mRS) score ≤1;
• Baseline National Institutes of Health Stroke Scale (NIHSS) 6-25 (both inclusive);
• Neuroimaging:
‣ Middle cerebral artery M1 or M2 occlusion confirmed by CTA/MRA, middle cerebral artery M1 or M2 being responsible for signs and symptoms of acute ischemic stroke;
⁃ target mismatch profile on CTP or MRI+PWI (ischemic core volume \<70mL, mismatch ratio ≥1.8, and mismatch volume ≥15mL);
• Written informed consent from patients or their legally authorized representatives.