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Intravenous rhTNK-tPA Before Stroke Thrombectomy in the Extended Time Window
Sponsor: Xinqiao Hospital of Chongqing
Summary
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.
Official title: Intravenous rhTNK-tPA Versus Placebo Before Endovascular Thrombectomy For Stroke Patient With Large Vessel Occlusion In The Extended Time Window: the BRIDGE-TNK EXTEND Randomized, Placebo-controlled, Double-blind Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
820
Start Date
2025-10-21
Completion Date
2028-02-29
Last Updated
2025-12-31
Healthy Volunteers
No
Conditions
Interventions
Intravenous rhTNK-tPA
Patients will received intravenous rhTNK-tPA
Intravenous placebo
Patients will received intravenous placebo
Endovascular thrombectomy
Patients will received endovascular thrombectomy
Locations (4)
Wuhan No. 1 Hospital
Wuhan, Hubei, China
Xiangtan Central Hospital
Xiangtan, Hunan, China
Jiujiang First People's Hospital
Jiujiang, Jiangxi, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China