An observational study in Acute Ischemic Stroke and Tenecteplase, sponsored by First Affiliated Hospital of Guangxi Medical University. Recruiting at 1 site in China. Open to participants aged 80 Years and older. Per ClinicalTrials.gov, last updated 2026-08-31.
Sponsored by First Affiliated Hospital of Guangxi Medical University · Observational
The benefit of intravenous tenecteplase in very old patients with acute ischemic stroke (AIS) remain uncertain. This real-world study aims to evaluate the effectiveness and safety of intravenous tenecteplase in AIS patients aged 80 years or older within 4.5 hours of symptom onset.
The study is an investigator-initiated, multicenter, prospective, observational, real-world registry designed to evaluate the effectiveness and safety of intravenous tenecteplase in AIS patients aged 80 years or older within 4.5 hours of symptom onset. The primary outcome is excellent outcome, as defined by a score of 0 or 1 on modified Rankin Scale (mRS) at 90 days. The study is anticipated to enroll at least 392 participants, with no less than 196 participants in the tenecteplase group.
2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.
This study's planned enrollment of 392 is above the median of 300 across 771 observational studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →First Affiliated Hospital of Guangxi Medical University is the lead sponsor of 41 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
This study will consecutively screen patients with acute ischemic stroke (AIS) who are over 80 years of age and arrive at the hospital within 4.5 hours of symptom onset.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Standard medical treatment
Other: Standard medical care
Intravenous tenecteplase thrombolysis
Drug: Tenecteplase (TNK) (0.25 mg/kg, to maximum of 25mg) · Other: Standard medical care
Drug page: Tenecteplase
Tenecteplase is administered as a single intravenous bolus at a dose of 0.25 mg/kg, with a maximum of 25 mg.
Standard medical treatment should adhere to clinical guidelines and usual care at site, including antiplatelet therapy, anticoagulant therapy, lipid-lowering therapy, antihypertensive drugs, etc., as determined by the local investigators.
Excellent outcome
The proportion of modified Rankin Scale (mRS) score of 0-1 at 90 days
Time frame: 90 (±14) days
Level of disability
Ordinal shift analysis of the mRS with 5-6 merged at 90 days.
Time frame: 90 (±14) days
Functional independence
The proportion of mRS score of 0-2 at 90 days.
Time frame: 90 (±14) days
Early neurological improvement
The proportion of NIHSS 0-1 or ≥4 points reduction at 24 hours.
Time frame: 24 (±12) hours
Change in stroke severity
The change of NIHSS score from enrollment to 7 days or at discharge (whichever comes first).
Time frame: 7 (±1) days or at discharge
Quality of life measured by EQ-5D-5L
EQ-5D-5L scale score at 90 days.
Time frame: 90 (±14) days
Symptomatic intracranial hemorrhage
Incidence of symptomatic intracranial hemorrhage within 36 hours from enrollment (Heidelberg criteria).
Time frame: 24 (±12) hours
Any intracranial hemorrhage
Incidence of any intracranial hemorrhage within 36 hours from enrollment (Heidelberg classification).
Time frame: 24 (±12) hours
Extracranial bleeding
Incidence of moderate-to-severe extracranial bleeding (GUSTO criteria) within 36 hours from enrollment.
Time frame: 24 (±12) hours
Mortality
All cause death within 90 days.
Time frame: 90 days
Plan to share: Yes — Data supporting the findings of the study are available on reasonable request after approval of a proposal from the principal investigator.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
No publications or documents are linked to this record.
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First Affiliated Hospital of Guangxi Medical University