Official Title

A Phase 3, Multicenter, Prospective, Randomized, Open Label, Blinded-endpoint (PROBE) Controlled Trial of Recombinant Human TNK Tissue-type Plasminogen Activator (rhTNK-tPA) for Injection Versus Standard Medical Treatment for Acute Ischemic Stroke Due to Large Vessel Occlusion With Perfusion Mismatch up to 24 Hours of Symptom Onset

Brief Summary

The trial is a multicenter, prospective, block randomized, open label, blinded-endpoint (PROBE) controlled design. Patients with acute ischemic stroke due to large vessel occlusion within 4.5-24 hours of symptom onset (including wake-up stroke and unwitnessed stroke) will be randomized 1:1 to 0.25mg/kg intravenous tenecteplase or standard medical treatment.

Detailed Description

The study will be a multicenter, prospective, randomized, open label, blinded-endpoint (PROBE), controlled phase 3 trial (2 arms with 1:1 randomization) in ischemic stroke due to large vessel occlusion with perfusion mismatch up to 24 hours of symptom onset. The target mismatch profiles on CTP or MRI perfusion weighted imaging include ischemic core volume<70 mL, mismatch ratio≥1.8 and mismatch volume≥15 mL demonstrated by a certified automatic software. The sample size is 516 patients.

Principal Investigator

Yongjun Wang

Study Start (Actual)

2022-04-09

Primary Completion (Estimated)

2023-08

Study Completion (Estimated)

2023-12

Enrollment (Estimated)

516