Actively Recruiting
Intravenous rhTNK-tPA Before Stroke Thrombectomy in the Extended Time Window
Led by Xinqiao Hospital of Chongqing · Updated on 2025-12-31
820
Participants Needed
4
Research Sites
123 weeks
Total Duration
On this page
Sponsors
X
Xinqiao Hospital of Chongqing
Lead Sponsor
T
The First Affiliated Hospital of Nanchang University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Intravenous rhTNK-tPA Before Stroke Thrombectomy in the Extended Time Window
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Acute ischemic stroke occurring within 4.5 to 24 hours of last known well
- No significant disability before stroke: pre-stroke modified Rankin Scale 42 if under 80 years, 41 if 80 years or older
- Baseline NIH Stroke Scale score of 5 or higher
- Imaging shows occlusion in specific brain arteries (M1/M2 MCA, A1 ACA, V4 vertebral, basilar, or P1 PCA with diameter 40.75 mm for A1 or P1)
- For anterior circulation strokes, perfusion imaging shows mismatch ratio 1.8, mismatch volume 15 mL, and ischemic core volume less than 70 mL, or MRI diffusion-weighted imaging mismatch with no FLAIR change
- For posterior circulation strokes, pc-ASPECTS score of 6 or greater
- Planned to receive endovascular thrombectomy
- Patient or legal representative provides written informed consent
You will not qualify if you...
- Intracranial hemorrhage confirmed by CT or MRI
- Already received intravenous thrombolytic treatment after the current stroke
- Pregnancy or breastfeeding
- Participation in other investigational drug trials
- Arterial tortuosity or vascular anomalies preventing access to target vessel
- Pre-existing neurological or psychiatric disorders affecting neurological assessments
- Large intracranial tumors larger than 3 cm (except small meningiomas 4 cm)
- Intracranial aneurysm or arteriovenous malformation
- Terminal illness with life expectancy under 6 months
- Expected inability to complete follow-up assessments
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Wuhan No. 1 Hospital
Wuhan, Hubei, China, 430000
Actively Recruiting
2
Xiangtan Central Hospital
Xiangtan, Hunan, China, 421001
Actively Recruiting
3
Jiujiang First People's Hospital
Jiujiang, Jiangxi, China
Actively Recruiting
4
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Actively Recruiting
Research Team
Z
Zhongming Qiu, MD
CONTACT
J
Jing Lin, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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