Acute Ischemic Stroke, Tenecteplase
Conditions
Brief summary
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
Tenecteplase is administered as a single intravenous bolus at a dose of 0.25 mg/kg, with a maximum of 25 mg.
OTHERStandard 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.
Sponsors
First Affiliated Hospital of Guangxi Medical University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
80 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Excellent outcome | 90 (±14) days | The proportion of modified Rankin Scale (mRS) score of 0-1 at 90 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life measured by EQ-5D-5L | 90 (±14) days | EQ-5D-5L scale score at 90 days. |
| Level of disability | 90 (±14) days | Ordinal shift analysis of the mRS with 5-6 merged at 90 days. |
| Functional independence | 90 (±14) days | The proportion of mRS score of 0-2 at 90 days. |
| Early neurological improvement | 24 (±12) hours | The proportion of NIHSS 0-1 or ≥4 points reduction at 24 hours. |
| Change in stroke severity | 7 (±1) days or at discharge | The change of NIHSS score from enrollment to 7 days or at discharge (whichever comes first). |
Countries
China
Contacts
CONTACTDong Pan, MD, PhD
PRINCIPAL_INVESTIGATORYuan Wu, MD, PhD
First Affiliated Hospital of Guangxi Medical University
Outcome results
None listed