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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Stroke, Acute Ischemic

In brief

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.

Key facts

Study ID

NCT06987305

Run by

Xinqiao Hospital of Chongqing

People needed

820

Starts

2025-10-21

Expected to finish

2028-02-29

Last updated by the study team

2025-12-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Wuhan No. 1 Hospital — Wuhan, Hubei, China (enrolling)
• Xiangtan Central Hospital — Xiangtan, Hunan, China (enrolling)
• Jiujiang First People's Hospital — Jiujiang, Jiangxi, China (enrolling)
• The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (enrolling)

Full record on ClinicalTrials.gov

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