Ischemic stroke
Conditions
Interventions
Experimental group:Subjects assigned to this arm will receive an intravenous bolus of 0.25mg/kg Tenecteplase. Subsequently, standard treatment based on the guidelines was administered.
Control group:Subjects assigned to this arm will receive an intravenous 0.9 mg/kg alteplase(10% bolus +90% infusion/1 hour). Subsequently, standard treatment based on the guidelines was administered.
Sponsors
Tianjin Huanhu Hospita
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1.Age>=18 years. 2.Pre-stroke modified Rankin Scale (mRS) score=4. 5.Imaging criteria: A mismatch between DWI and FLAIR on MRI;Or CT perfusion: ischemic infarct core =1.2, mismatch volume >=10ml. 6.Written informed consent from patients or their legally authorized representatives.
Exclusion criteria
Exclusion criteria: 1. Planned for endovascular therapy.2. Significant pre-existing neurological disability (pre-stroke modified Rankin Scale score>=2).3. Presence of intracranial hemorrhage, vascular malformation, aneurysm, brain abscess, malignant space-occupying lesion, or other non-ischemic intracranial disease at baseline. 4. Absolute contraindications to thrombolysis. 5. Known allergy to tenecteplase or alteplase. 6. Life expectancy of less than 6 months.7. Pregnancy or lactation; 8. Evident or recent acute pancreatitis.9. Documented ulcerative gastrointestinal disease, esophageal varices, arterial-venous malformation, or tumor with increased risk of bleeding within 3 months.10. Significant severe liver disease, including liver failure, cirrhosis, portal hypertension, active hepatitis or major surgery or significant trauma within 3 months.11. Poor-quality baseline imaging that is uninterpretable per the study protocol.12. Participation in other interventional clinical trials within 3 months prior to screening.13. Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects with mRS(0-1) at 90 ±7 days;The incidence of symptomatic intracranial hemorrhage (sICH) within 36 hours( defined by ECASSIII); | — |
Secondary
| Measure | Time frame |
|---|---|
| Ordinal distribution of mRS at 90 ±7days;Proportion of subjects with mRS(0-2) at 90 ±7 days;The incidence of early neurological improvement (ENI) after thrombolytic therapy;The incidence of stroke deterioration within 7 ±1days ( an increase in NIHSS score >=2, excluding cases attributable to intracerebral hemorrhage);The incidence of stroke recurrence and other vascular events within 90 days; The incidence of any intracranial hemorrhage within 36 hours (defined by ECASSIII);Rate of Overall mortality at 90±7 days;Major Systemic Bleeding; | — |
Countries
China
Contacts
Public ContactJialing Wu
Tianjin Huanhu Hospital
Outcome results
None listed