NCT07094763 Efficacy and Safety of Tenecteplase Intravenous Thrombolysis in Acute Posterior Circulation Ischemic Stroke Within 4.5-24 Hours After Onset
| NCT ID | NCT07094763 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The First Affiliated Hospital of University of Science and Technology of China |
| Condition | Acute Ischemic Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 406 participants |
| Start Date | 2025-11-05 |
| Primary Completion | 2027-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 406 participants in total. It began in 2025-11-05 with a primary completion date of 2027-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study aims to evaluate the efficacy and safety of tenecteplase (TNK) intravenous thrombolysis within the extended time window (4.5 to 24 hours) in patients with acute posterior circulation ischemic stroke.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07094763 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Acute Ischemic Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07094763 currently recruiting?
Yes, NCT07094763 is actively recruiting participants. Contact the research team at andinghu@ustc.edu.cn for enrollment information.
Where is the NCT07094763 trial being conducted?
This trial is being conducted at Hefei, China.
Who is sponsoring the NCT07094763 clinical trial?
NCT07094763 is sponsored by The First Affiliated Hospital of University of Science and Technology of China. The trial plans to enroll 406 participants.
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