Tenecteplase for Late-Window Stroke Guided by DWI-FLAIR Mismatch (NCT07540416) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Tenecteplase for Late-Window Stroke Guided by DWI-FLAIR Mismatch
China564 participantsStarted 2026-05-01
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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);
✓. Imaging criteria:
✓. 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;
✓. NIHSS score 4-25;
✓. First-ever stroke or previous stroke without significant disability (pre-stroke mRS ≤ 1);
✓. Signed informed consent from the patient or legally authorized representative.
Exclusion criteria
✕. Planned endovascular treatment;
✕
What they're measuring
1
Modified Rankin Scale (mRS)
Timeframe: 90 ± 7 days
Trial details
NCT IDNCT07540416
SponsorThe First Affiliated Hospital of Zhengzhou University