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

This randomized, double-blind, placebo-controlled phase III clinical trial aims to evaluate the efficacy and safety of intravenous recombinant human tenecteplase (rhTNK-tPA) in acute ischemic stroke patients with large vessel occlusion presenting 4.5-24 hours after last known well. The study will address two primary questions: 1) Whether rhTNK-tPA enhances pre-thrombectomy reperfusion rates and improves 90-day functional outcomes compared to placebo; 2) Whether rhTNK-tPA increases the risk of symptomatic intracranial hemorrhage and mortality. Participants will be randomized to receive either a single bolus of rhTNK-tPA (0.25 mg/kg, max 25 mg) or matching placebo administered intravenously over 5 seconds. Key assessments include repeat neuroimaging (CT/CTA or MRI/MRA) at 24 hours post-treatment to evaluate reperfusion, NIH Stroke Scale score at day 5-7, and modified Rankin Scale score assessment at 90 days. Safety monitoring will focus on hemorrhagic transformation and mortality events throughout the study period.

NCT Number	NCT06987305
Lead Sponsor	Xinqiao Hospital of Chongqing Collaborators: The First Affiliated Hospital of Nanchang University, China Shijiazhuang Pharmaceutical Company RECOMGEN PHARMACEUTICAL (GUANGZHOU) CO.,LTD
Conditions	Stroke, Acute Ischemic
Enrollment	820 participants
Start Date	2025-10-21
Primary Completion	2027-10-31 (estimated)
Study Completion	2028-02-29 (estimated)
Updated on ClinicalTrials.gov	2025-12-31