Tenecteplase Tested for Late-Window Stroke Using MRI Brain Imaging

Trial details

Who runs it

The First Affiliated Hospital of Zhengzhou University

Trial code

NCT07540416

Record updated

9 November 2026

Original description

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:Read full original descriptionShow less

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

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.

Inclusion: 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: Intracranial or spinal cord surgery within 3 months; Heparin therapy within 24 hours; Oral anticoagulation therapy; Major surgery within 1 month; Gastrointestinal or urinary tract hemorrhage within the previous 30 days; Participation in other interventional clinical trials within the previous 3 months; Subarachnoid or intracranial hemorrhage; History of intracranial hemorrhage; Active internal hemorrhage; Neurological deficit after epileptic seizures; Myocardial infarction within 3 months; Allergy to study drugs; 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; platelet count of <100000/mm3; Oral warfarin is being taken and INR>1.6 or APTT abnormal; Blood glucose < 50 mg/dl (2.7mmol/L); Planned endovascular treatment; Contradictory to MRI examination; MRI image not qualified for evaluation; Obvious head injuries or strokes within 3 months; Intracranial tumor, arteriovenous malformation or aneurysm; Aortic arch dissection; Systolic pressure≥185 mmHg or diastolic pressure≥110 mmHg; Pregnancy; Unlikely to adhere to the trial protocol or follow-up.

ClinicalTrials.gov NCT07540416