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NCT07540416

PHASE3

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

Sponsor: The First Affiliated Hospital of Zhengzhou University

View on ClinicalTrials.gov

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.

Official title: Tenecteplase Thrombolysis for Acute Ischemic Stroke in the 4.5-9-Hour Window Guided by DWI-FLAIR Mismatch: A Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

564

Start Date

2026-05-01

Completion Date

2028-06-30

Last Updated

2026-04-20

Healthy Volunteers

Conditions

Acute Ischemic Stroke

Interventions

DRUG

TNK-tPA

TNK-tPA (0.25 mg/kg, to maximum of 25mg)

DRUG

Aspirin

Asprin (300mg)

DRUG

Placebo

Asprin (placebo)

DRUG

Placebo

TNK-tPA (placebo)

Inclusion Criteria: 1. Age ≥ 18 years; 2. 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); 3. Imaging criteria: 1. DWI-FLAIR mismatch: visible lesion on DWI with no marked visible lesion on FLAIR; 2. 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; 4. NIHSS score 4-25; 5. First-ever stroke or previous stroke without significant disability (pre-stroke mRS ≤ 1); 6. Signed informed consent from the patient or legally authorized representative. Exclusion Criteria: 1. Planned endovascular treatment; 2. Contradictory to MRI examination; 3. MRI image not qualified for evaluation; 4. Serious neurological deficits before onset (mRS≥2); 5. Obvious head injuries or strokes within 3 months; 6. Subarachnoid or intracranial hemorrhage; 7. History of intracranial hemorrhage; 8. Intracranial tumor, arteriovenous malformation or aneurysm; 9. Intracranial or spinal cord surgery within 3 months; 10. Active internal hemorrhage; 11. platelet count of \<100000/mm3; 12. Aortic arch dissection; 13. Heparin therapy within 24 hours; 14. Oral warfarin is being taken and INR\>1.6 or APTT abnormal; 15. Oral anticoagulation therapy; 16. Systolic pressure≥185 mmHg or diastolic pressure≥110 mmHg; 17. Blood glucose \< 50 mg/dl (2.7mmol/L); 18. Pregnancy; 19. Neurological deficit after epileptic seizures; 20. Major surgery within 1 month; 21. Gastrointestinal or urinary tract hemorrhage within the previous 30 days; 22. Myocardial infarction within 3 months; 23. Allergy to study drugs; 24. Unlikely to adhere to the trial protocol or follow-up; 25. Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study; 26. Participation in other interventional clinical trials within the previous 3 months.

Locations (1)

The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan

Zhengzhou, Henan, China

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (1)