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

Starting soon · Phase 3 · Has a placebo group

Conditions studied: Acute Ischemic Stroke

In brief

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.

Key facts

Study ID

NCT07540416

Run by

The First Affiliated Hospital of Zhengzhou University

People needed

564

Starts

2026-05-01

Expected to finish

2028-06-30

Last updated by the study team

2026-04-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Planned endovascular treatment;
• Contradictory to MRI examination;
• MRI image not qualified for evaluation;
• Serious neurological deficits before onset (mRS≥2);
• Obvious head injuries or strokes within 3 months;
• Subarachnoid or intracranial hemorrhage;
• History of intracranial hemorrhage;
• Intracranial tumor, arteriovenous malformation or aneurysm;
• Intracranial or spinal cord surgery within 3 months;
• Active internal hemorrhage;
• platelet count of <100000/mm3;
• Aortic arch dissection;
• Heparin therapy within 24 hours;
• Oral warfarin is being taken and INR>1.6 or APTT abnormal;
• Oral anticoagulation therapy;
• Systolic pressure≥185 mmHg or diastolic pressure≥110 mmHg;
• Blood glucose < 50 mg/dl (2.7mmol/L);
• Pregnancy;
• Neurological deficit after epileptic seizures;
• Major surgery within 1 month;
• Gastrointestinal or urinary tract hemorrhage within the previous 30 days;
• Myocardial infarction within 3 months;
• Allergy to study drugs;
• Unlikely to adhere to the trial protocol or follow-up;
• 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;

Where it is running

• The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan — Zhengzhou, Henan, China

Full record on ClinicalTrials.gov

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