Tenecteplase for Posterior Circulation Stroke Between 4.5 and 24 Hours

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, randomized trial compares intravenous tenecteplase plus standard care to standard medical therapy in adults with imaging-confirmed or vascular-imaging-supported posterior circulation ischemic stroke treated 4.5 to 24 hours after onset. Eligible participants are randomized 1:1 and will be followed up by phone at 3 months and 1 year, with functional outcome measured by the modified Rankin Scale. The primary goal is to determine the safety and efficacy of TNK in this extended time window for posterior circulation strokes. Imaging and clinical criteria ensure inclusion of patients with relevant hypoperfusion or large-vessel involvement in the posterior circulation. Exclusion criteria cover contraindications to TNK and plans for immediate thrombectomy within 3 months.

Why it matters

Who can join: the full rules

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.

Where it's running

• The First Affiliated Hospital of the University of Science and Technology of China
  Hefei, China Recruiting

Study contacts

• Study coordinator: Wei Hu MD,PhD
• Email: andinghu@ustc.edu.cn
• Phone: +86055162284313

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.