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

Launched by THE FIRST AFFILIATED HOSPITAL OF UNIVERSITY OF SCIENCE AND TECHNOLOGY OF CHINA · Jul 23, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a medicine called tenecteplase (TNK) to see if it can safely help people who have had a type of stroke called an acute posterior circulation ischemic stroke. This kind of stroke affects the back part of the brain and happens when blood flow is blocked. The study is unique because it looks at giving this treatment later than usual—between 4.5 and 24 hours after stroke symptoms start—to see if it can still be effective and safe during this extended time.

People who might be eligible for this trial are adults 18 years or older who have had this specific kind of stroke confirmed by brain scans and who show signs of reduced blood flow in the back part of the brain. Their stroke should have started between 4.5 and 24 hours ago, and they need to have a moderate level of stroke severity. Before the stroke, they should have been living independently. Participants will be carefully screened to rule out conditions that might increase risks, such as recent bleeding, certain heart or brain conditions, or use of blood thinners. If eligible, patients or their family members will be asked to provide consent to join the study. The goal is to find out if giving tenecteplase during this later window can improve recovery safely, which could offer new treatment options for stroke patients who don’t get help right away.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥18 years.
• • 2. 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.
• • 3. 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).
• • 4. NIHSS score\>3.
• • 5. PC-ASPECTS ≥7 (if discrepancy exists between DWI and CT findings, CT assessment takes precedence).
• • 6. Pre-stroke mRS ≤1.
• • 7. Signed informed consent by the patient or legally authorized representative.
• Exclusion Criteria:
• • 1. Contraindication to tenecteplase or its components.
• • 2. Planing to receive endovascular therapy with thrombectomy, angioplasty or stenting whin 3 months.
• • 3. 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.
• • 4. History of intracranial hemorrhage.
• • 5. Stroke, myocardial infarction, severe traumatic brain injury, or intracranial/spinal surgery within the preceding 3 months.
• • 6. Intracranial tumor, arteriovenous malformation (AVM), or giant aneurysm.
• • 7. Active internal bleeding, major surgery, trauma, gastrointestinal/urinary tract bleeding within 3 weeks.
• • 8. Non-compressible arterial puncture within 1 week.
• • 9. Suspected aortic dissection.
• • 10. 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).
• • 11. Platelet dysfunction or platelet count \<100×10⁹/L.
• • 12. Uncontrolled hypertension (systolic BP \>180 mmHg or diastolic BP \>110 mmHg unresponsive to antihypertensive therapy).
• • 13. Uncontrolled hypoglycemia/hyperglycemia (\<50 mg/dL \[2.8 mmol/L\] or \>400 mg/dL \[22.2 mmol/L\]).
• • 14. Pregnancy or lactation.
• • 15. A life expectancy of less than three months.
• • 16. Participation in other clinical trials within 3 months or ongoing trial enrollment.
• • 17. Inability to follow up (e.g., no fixed residence, overseas patients).
• • 18. Patient deemed unsuitable for the trial by site investigator.