The goal of this clinical trial is to evaluate the efficacy and safety of tenecteplase administered 4.5-9 hours after stroke onset (defined as the time the patient was first found with symptoms, including wake-up stroke and unwitnessed stroke) in patients with acute ischemic stroke (AIS) guided by DWI-FLAIR mismatch on MRI. The main questions it aims to answer are:
1. Does tenecteplase improve functional outcomes at 90 days compared with standard treatments in AIS patients administered 4.5-9 hours after stroke onset guided by DWI-FLAIR mismatch? 2. The safety of tenecteplase thrombolysis for AIS patients in the 4.5-9 hours guided by DWI-FLAIR mismatch.
Researchers will compare tenecteplase to placebo to see if it is effective and safe for these patients.
Participants will be randomly assigned (1:1) immediately after randomization:
* Tenecteplase group: received tenecteplase, intravenously as a bolus administered over a period of 5 to 10 seconds at a dose of 0.25 mg per kilogram (maximum dose, 25 mg), plus aspirin placebo (300 mg). * Control group: aspirin (300 mg) plus tenecteplase placebo. From day 2 to day 90, all patients will be conformed to the 2023 Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke.
Age ≥ 18 years;
AIS with symptom onset 4.5-9 hours before enrollment, including wake-up stroke and unwitnessed stroke (onset time defined as when symptoms were first noticed);
DWI-FLAIR mismatch: visible lesion on DWI with no marked visible lesion on FLAIR;
DWI infarct core not exceeding one-third of the middle cerebral artery territory, one-half of the anterior cerebral artery territory, or one-half of the posterior cerebral artery territory;
Planned endovascular treatment;
Contradictory to MRI examination;
MRI image not qualified for evaluation;
Serious neurological deficits before onset (mRS≥2);
Parallel
TNK-tPA
DrugTNK-tPA (0.25 mg/kg, to maximum of 25mg)
Aspirin
DrugAsprin (300mg)
Placebo
DrugAsprin (placebo)
Placebo
DrugTNK-tPA (placebo)
Modified Rankin Scale (mRS)
Proportion of subjects of excellent outcome defined as mRS (0-1) at 90 ± 7 days.
Modified Rankin Scale (mRS)
Proportion of subjects of excellent outcome defined as mRS (0-2) at 90 ± 7 days.
Modified Rankin Scale (mRS)
Ordinal shift analysis of mRS at 90 days
National Institutes of Health Stroke Scale (NIHSS)
NIHSS change from baseline at 24 hours and 7 days.
Barthel (BI)
Barthel Index score at 90 ± 7 days.
Symptomatic intracranial hemorrhage (sICH)
Proportion of subjects with symptomatic intracranial hemorrhage (sICH) at 36 hours (according to the ECASS III criteria).
Death
Overall mortality rate at 90 days.
Systemic bleeding
Systemic bleeding at 90 days (according to the GUSTO criteria)
Adverse events (AEs)/ serious adverse events (SAEs)
Proportion of patients with adverse events (AEs)/ serious adverse events (SAEs) within 90 days.
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This trial is not recruiting at the moment. You can still explore other options:
