Tenecteplase for Late-Window Stroke Guided by DWI-FLAIR Mismatch
Condition(s) studied
Investigational drug(s) / intervention(s)
TNK-tPA: TNK-tPA (0.25 mg/kg, to maximum of 25mg)
Aspirin: Asprin (300mg)
Placebo: Asprin (placebo)
Placebo: TNK-tPA (placebo)
Study 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.
Eligibility
Primary outcome measure(s)
- Modified Rankin Scale (mRS) — 90 ± 7 days
Proportion of subjects of excellent outcome defined as mRS (0-1) at 90 ± 7 days.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan | Zhengzhou | Henan |
More The First Affiliated Hospital of Zhengzhou University trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07540416 on ClinicalTrials.gov ↗ ← All trials in China