Intravenous Tenecteplase in Very Old Patients With Acute Ischemic Stroke
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tenecteplase (TNK) (0.25 mg/kg, to maximum of 25mg), Standard medical care.
- Who it may be relevant to
- Registry conditions: Acute Ischemic Stroke, Tenecteplase. Basic parameters: from 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multicenter, Prospective, Observational, Real-World Registry Study of Intravenous Tenecteplase in Very Old Patients With Acute Ischemic Stroke
Overview
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.
Detailed description
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.
Interventions
- Drug Tenecteplase (TNK) (0.25 mg/kg, to maximum of 25mg)
Tenecteplase is administered as a single intravenous bolus at a dose of 0.25 mg/kg, with a maximum of 25 mg. - Other Standard medical care
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.
Primary outcome measures
- Excellent outcome [Time frame: 90 (±14) days]
Secondary outcome measures (5)
- Level of disability [Time frame: 90 (±14) days]
- Functional independence [Time frame: 90 (±14) days]
- Early neurological improvement [Time frame: 24 (±12) hours]
- Change in stroke severity [Time frame: 7 (±1) days or at discharge]
- Quality of life measured by EQ-5D-5L [Time frame: 90 (±14) days]
Eligibility criteria
Inclusion criteria
- Age > 80 years;
- Clinically diagnosed with acute ischemic stroke and arrived at the hospital within 4.5 hours of symptom onset;
- Informed consent signed by the patient or legally authorized representative.
Exclusion criteria
- Any contraindication to intravenous thrombolysis (excluding age);
- Previous treatment with other thrombolytic agents such as alteplase, urokinase, plasminogen activator, or reteplase;
- Current participation in other interventional studies;
- 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- The First Affiliated Hospital of Guangxi Medical University — Nanning
Identifiers
NCT: NCT07475936 · 2025-K0668