Efficacy and Safety of Tenecteplase Intravenous Thrombolysis in Acute Posterior Circulation Ischemic Stroke Within 4.5-24 Hours After Onset

This multicenter, prospective, randomized, controlled trial assesses the efficacy and safety of intravenous tenecteplase for acute posterior-circulation ischemic stroke treated 4.5-24 hours after onset. Participants with imaging-confirmed stroke will be randomly assigned 1:1 to receive either tenecteplase or standard medical therapy. Eligible patients must present within 4.5-24 hours from symptom onset, defined as the midpoint between last known normal and first observed neurological deficit. All participants will undergo telephone follow-up at 3 months and 1 year, with the modified Rankin Scale as the primary outcome measure.

Inclusion criteria

• Age ≥18 years.
• Meeting at least one of the following criteria: acute posterior circulation ischemic stroke confirmed by MRI; symptomatic stenosis or occlusion of a posterior circulation large vessel on vascular imaging (CTA/MRA/DSA); perfusion imaging demonstrating clinically relevant hypoperfusion in the posterior circulation territory.
• Onset time between 4.5-24 hours (for wake-up stroke or unwitnessed stroke, onset time is defined as the midpoint between last known well and symptom detection).
• NIHSS score>3.
• PC-ASPECTS ≥7 (if discrepancy exists between DWI and CT findings, CT assessment takes precedence).
• Pre-stroke mRS ≤1.
• Signed informed consent by the patient or legally authorized representative.

Exclusion criteria

• Contraindication to tenecteplase or its components.
• Planing to receive endovascular therapy with thrombectomy, angioplasty or stenting whin 3 months.
• Acute anterior circulation infarction confirmed by MRI, anterior circulation large vessel occlusion on vascular imaging (CTA/MRA/DSA), or anterior circulation hypoperfusion on perfusion imaging.
• History of intracranial hemorrhage.
• Stroke, myocardial infarction, severe traumatic brain injury, or intracranial/spinal surgery within the preceding 3 months.
• Intracranial tumor, arteriovenous malformation (AVM), or giant aneurysm.
• Active internal bleeding, major surgery, trauma, gastrointestinal/urinary tract bleeding within 3 weeks.
• Non-compressible arterial puncture within 1 week.
• Suspected aortic dissection.
• Clinically significant bleeding or coagulopathy, including: Warfarin use with INR >1.7 or PT >15 s; Low-molecular-weight heparin within 24 hours; Direct oral anticoagulants within 48 hours; Laboratory abnormalities (e.g., APTT >40 s).
• Platelet dysfunction or platelet count <100×10⁹/L.
• Uncontrolled hypertension (systolic BP >180 mmHg or diastolic BP >110 mmHg unresponsive to antihypertensive therapy).
• Uncontrolled hypoglycemia/hyperglycemia (<50 mg/dL [2.8 mmol/L] or >400 mg/dL [22.2 mmol/L]).
• Pregnancy or lactation.
• A life expectancy of less than three months.
• Participation in other clinical trials within 3 months or ongoing trial enrollment.
• Inability to follow up (e.g., no fixed residence, overseas patients).
• Patient deemed unsuitable for the trial by site investigator.