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RECRUITING
NCT06987305
PHASE3

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

Sponsor: Xinqiao Hospital of Chongqing

View on ClinicalTrials.gov

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

Interventions

DRUG

Intravenous rhTNK-tPA

Patients will received intravenous rhTNK-tPA

DRUG

Intravenous placebo

Patients will received intravenous placebo

PROCEDURE

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