Tenecteplase for late-window stroke guided by DWI-FLAIR mismatch

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 randomized trial compares intravenous tenecteplase to placebo in adults with acute ischemic stroke 4.5–9 hours after onset, guided by DWI-FLAIR mismatch on MRI. Eligible participants have a limited infarct core and measurable DWI-FLAIR mismatch, and must meet specific neurological and imaging criteria. Treatment is given as a rapid IV bolus of tenecteplase or placebo, with safety and functional outcomes assessed at 90 days. The study builds on prior work showing benefit of imaging-guided thrombolysis beyond 4.5 hours and aims to determine efficacy and safety in this later window. Recruitment centers are located at The First Affiliated Hospital of Zhengzhou University in Zhengzhou, Henan.

Why it matters

Who can join: the full rules

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. Obvious head injuries or strokes within 3 months;
5. Subarachnoid or intracranial hemorrhage;
6. History of intracranial hemorrhage;
7. Intracranial tumor, arteriovenous malformation or aneurysm;
8. Intracranial or spinal cord surgery within 3 months;
9. Active internal hemorrhage;
10. platelet count of \<100000/mm3;
11. Aortic arch dissection;
12. Heparin therapy within 24 hours;
13. Oral warfarin is being taken and INR\>1.6 or APTT abnormal;
14. Oral anticoagulation therapy;
15. Systolic pressure≥185 mmHg or diastolic pressure≥110 mmHg;
16. Blood glucose \< 50 mg/dl (2.7mmol/L);
17. Pregnancy;
18. Neurological deficit after epileptic seizures;
19. Major surgery within 1 month;
20. Gastrointestinal or urinary tract hemorrhage within the previous 30 days;
21. Myocardial infarction within 3 months;
22. Allergy to study drugs;
23. Unlikely to adhere to the trial protocol or follow-up;
24. 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;
25. Participation in other interventional clinical trials within the previous 3 months.

Where it's running

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

Study contacts

• Study coordinator: Bo Song, MD
• Email: fccsongb@zzu.edu.cn
• Phone: +86-371-66278068

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.