Intravenous Tenecteplase in Very Old Adults with Acute Ischemic Stroke
Official title: A Multicenter, Prospective, Observational, Real-World Registry Study of Intravenous Tenecteplase in Very Old Patients With Acute Ischemic Stroke
Run by First Affiliated Hospital of Guangxi Medical University · NCT07475936 · Data updated 2026-11-12
This study tests whether giving tenecteplase through a vein within 4.5 hours of stroke onset helps people 80 and older.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 80 Years and up |
| Sex | All |
| Enrollment | 392 (estimated) |
| Sponsor | First Affiliated Hospital of Guangxi Medical University Academic / other |
| Locations | 1 site (Nanning, Guangxi) |
| Status | Recruiting |
| Started | March 22, 2026 |
| Main results expected | December 2027 |
| Study ends | December 2027 |
| Registry record updated | August 31, 2026 |
| Trial ID | NCT07475936 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 80 years or older diagnosed with acute ischemic stroke who can be treated within 4.5 hours of symptom onset and provide informed consent.
✕Probably not a fit
Patients with contraindications to intravenous thrombolysis or those not receiving tenecteplase may not experience benefit, and some may have unfavorable outcomes due to stroke severity or comorbidity.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a multicenter, prospective, observational registry that collects real-world data on the safety and effectiveness of intravenous tenecteplase in AIS patients aged 80 years or older treated within 4.5 hours. The primary goal is to see how many patients achieve an excellent outcome (modified Rankin Scale 0-1) at 90 days. Enrollment targets at least 392 participants, with no fewer than 196 receiving tenecteplase, alongside standard medical care. The study design does not randomize treatment and reflects real-world clinical practice across participating centers. Outcomes will inform on feasibility, safety, and potential benefit in this very elderly population.
Why it matters
Potential benefit: If successful, the findings could clarify whether tenecteplase is a safe and effective option for improving recovery in very old AIS patients treated early.
How similar studies have gone: Previous studies have explored thrombolysis in older adults, but this real-world registry specifically targets very elderly patients within 4.5 hours, making it a novel observational effort in this age group.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age \> 80 years; 2. Clinically diagnosed with acute ischemic stroke and arrived at the hospital within 4.5 hours of symptom onset; 3. Informed consent signed by the patient or legally authorized representative. Exclusion Criteria: 1. Any contraindication to intravenous thrombolysis (excluding age); 2. Previous treatment with other thrombolytic agents such as alteplase, urokinase, plasminogen activator, or reteplase; 3. Current participation in other interventional studies; 4. The investigator deems the patient unsuitable for this study or the study might pose significant risk to the patient (e.g., due to psychiatric disorders, cognitive or emotional impairments that prevent understanding or adherence to study procedures and/or follow-up).
Where it's running
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The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China Recruiting
Study contacts
- Principal investigator: Yuan Wu, MD, PhD — First Affiliated Hospital of Guangxi Medical University
- Study coordinator: Dong Pan, MD, PhD
- Email: dongpan012@hotmail.com
- Phone: 86-156 2648 3251
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.