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

RecruitingPhase 3Ages 18 Years - anyAllXinqiao Hospital of Chongqing
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In plain words

What the trial is, and whether it could suit you

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 as

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1. Age ≥18 years; 2. Acute ischemic stroke presenting within 4.5-24 hours of last known well; 3. No significant pre-stroke functional disability: for age \<80 years, pre-stroke modified Rankin scale (mRS) ≤2; for age ≥80 years, prestroke mRS ≤1; 4. Baseline NIHSS score ≥5; 5. Imaging criteria of BOTH: 1. 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; 2. 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. 6. Plan to received endovascular thrombectomy; 7. The patient or their legal representative provides written informed consent. Exclusion Criteria: 1. Intracranial hemorrhage confirmed by CT/MRI; 2. Already received intravenous thrombolytic after index stroke.; 3. Pregnancy or lactation; 4. Concurrent participation in other investigation drug clinical trials; 5. Arterial tortuosity or other vascular anomalies precluding endovascular access to target vessel; 6. Pre-existing neurological/psychiatric disorders interfering with neurological assessment; 7. Space-occupying intracranial tumors (except small meningiomas ≤3 cm); 8. Intracranial aneurysm or arteriovenous malformation; 9. Terminal illness with life expectancy \<6 months; 10. Anticipated inability to complete follow-up assessments.
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What it tests

  • Intravenous rhTNK-tPA
  • Intravenous placebo
  • Endovascular thrombectomy
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Where

4 sites
Wuhan No. 1 Hospital
Wuhan, China
Xiangtan Central Hospital
Xiangtan, China
Jiujiang First People's Hospital
Jiujiang, China
The First Affiliated Hospital of Nanchang University
Nanchang, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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