Status:
RECRUITING
Intravenous rhTNK-tPA Before Stroke Thrombectomy in the Extended Time Window
Lead Sponsor:
Xinqiao Hospital of Chongqing
Collaborating Sponsors:
The First Affiliated Hospital of Nanchang University
China Shijiazhuang Pharmaceutical Company RECOMGEN PHARMACEUTICAL (GUANGZHOU) CO.,LTD
Conditions:
Stroke, Acute Ischemic
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 p...
Detailed Description
This multicenter, phase III trial employs a randomized, double-blind, placebo-controlled design to investigate the therapeutic window extension for rhTNK-tPA in large vessel occlusion stroke. Eligible...
Eligibility Criteria
Inclusion
- Age ≥18 years;
- Acute ischemic stroke presenting within 4.5-24 hours of last known well;
- No significant pre-stroke functional disability: for age \<80 years, pre-stroke modified Rankin scale (mRS) ≤2; for age ≥80 years, prestroke mRS ≤1;
- Baseline NIHSS score ≥5;
- Imaging criteria of BOTH:
- Occlusion on CTA/MRA in one of the following vessels: M1/M2 segment of middle cerebral artery, A1 segment of anterior cerebral artery, V4 segment of vertebral artery, basilar artery, or P1 segment of posterior cerebral artery. For A1, or P1 occlusions, vessel diameter must be ≥0.75 mm;
- For anterior circulation occlusion: CTP/MRP demonstrating mismatch ratio ≥1.8, absolute mismatch volume ≥15 mL, and ischemic core volume \<70 mL; OR have a mismatch between the presence of an abnormal signal on MRI diffusion-weighted imaging and no visible signal change on FLAIR. For posterior circulation occlusion: pc-ASPECTS score ≥6.
- Plan to received endovascular thrombectomy;
- The patient or their legal representative provides written informed consent.
Exclusion
- Intracranial hemorrhage confirmed by CT/MRI;
- Already received intravenous thrombolytic after index stroke.;
- Pregnancy or lactation;
- Concurrent participation in other investigation drug clinical trials;
- Arterial tortuosity or other vascular anomalies precluding endovascular access to target vessel;
- Pre-existing neurological/psychiatric disorders interfering with neurological assessment;
- Space-occupying intracranial tumors (except small meningiomas ≤3 cm);
- Intracranial aneurysm or arteriovenous malformation;
- Terminal illness with life expectancy \<6 months;
- Anticipated inability to complete follow-up assessments.
Key Trial Info
Start Date :
October 21 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 29 2028
Estimated Enrollment :
820 Patients enrolled
Trial Details
Trial ID
NCT06987305
Start Date
October 21 2025
End Date
February 29 2028
Last Update
December 31 2025
Active Locations (4)
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1
Wuhan No. 1 Hospital
Wuhan, Hubei, China, 430000
2
Xiangtan Central Hospital
Xiangtan, Hunan, China, 421001
3
Jiujiang First People's Hospital
Jiujiang, Jiangxi, China
4
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China