Clinical Trial

Tenecteplase for Late-Window Stroke Guided by DWI-FLAIR Mismatch

Study acronym: TRUST-MISMATCH
Not Yet Recruiting Phase 3
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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.
Trial Details
NCT Number NCT07540416
Lead Sponsor The First Affiliated Hospital of Zhengzhou University
Conditions Acute Ischemic Stroke
Enrollment 564 participants
Start Date 2026-05-01
Primary Completion 2027-12-31 (estimated)
Study Completion 2028-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-04-20