Comparing Intravenous rhTNK-tPA and Placebo Before Endovascular Thrombectomy for Adults with Large Vessel Occlusion Stroke in an Extended Treatment Window

What this Trial Is About

Researchers are evaluating intravenous recombinant human tenecteplase rhTNK-tPA in adults who have had an acute ischemic stroke caused by a large vessel blockage. This phase III, randomized, double-blind, placebo-controlled trial aims to determine if rhTNK-tPA improves blood flow before thrombectomy and enhances functional recovery at 90 days. The study also monitors whether rhTNK-tPA increases risks such as symptomatic brain bleeding or death. Participants are randomly assigned to receive either a single intravenous dose of rhTNK-tPA 0.25 mgkg, up to 25 mg or a placebo given over 5 seconds. All participants will undergo endovascular thrombectomy to remove the vessel blockage. Key imaging tests like CT or MRI are done before and 24 hours after treatment to assess brain blood flow and tissue damage. During the study, patients will have neurological evaluations including stroke severity scales between days 5 and 7, and functional outcome assessments at 90 days. Safety monitoring focuses on bleeding events and mortality during the 90-day period. The trial includes careful review of complications and adverse events, with independent oversight to ensure participant safety and data integrity.

Intravenous rhTNK-tPA Before Stroke Thrombectomy in the Extended Time Window