CHinese ischEmic Stroke Beyond 4.5 Hours With TeNecteplase Under Optimized Non-Contrast CT Selection

Launched by HUASHAN HOSPITAL · May 20, 2025

Keywords

ClinConnect Summary

The CHABLIS-NEXT trial is a research study designed to test a new treatment for patients who have had an acute ischemic stroke, which happens when blood flow to the brain is blocked. This trial will look at whether a specific dose of a medication called TNK can safely help patients who show no significant brain damage on a certain type of brain scan, even if it has been more than 4.5 hours since their stroke symptoms started. The study will include people aged 18 and older who meet certain criteria, such as having a specific type of stroke and a certain level of disability before the stroke.

If someone is eligible and decides to participate, they will receive the medication and be monitored closely for any side effects and effectiveness. It’s important to note that some individuals may not be able to join this study, especially if they have certain medical conditions or have had procedures related to strokes recently. This trial is a step towards improving treatments for stroke patients, especially during the critical time window after a stroke occurs.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Suspected acute ischemic stroke of anterior cerebral circulation.
• • 2. Last known well time \>4.5 hours.
• • 3. Age ≥18 years old.
• • 4. Baseline NIHSS (National Institutes of Health Stroke Scale) score \>5.
• • 5. Premorbid modified Rankin Scale (mRS) ≤1.
• • 6. Imaging criteria: Automated infarct segmentation by NCCT post-processing model indicates infarct core volume \<50 mL with no visible hypodensity in \>1/3 of the MCA territory.
• • 7. Informed consent signed by the patient or the patient's legally authorized representative.
• Exclusion Criteria:
• • 1. Obvious hypodensity on NCCT deemed related with the current stroke event, with no expected benefit from thrombolysis as assessed by the investigators
• • 2. Endovascular thrombectomy (EVT) planned at the time of randomization
• • 3. Allergy to the test drug and its ingredients
• • 4. Rapidly improving symptoms at the discretion of the investigator
• • 5. Any sign of an acute intracranial hemorrhage or subarachnoid hemorrhage identified on baseline NCCT
• • 6. History of any intracranial hemorrhage
• • 7. History of ischemic stroke or major head trauma within the last 3 months
• • 8. History of intracranial/intraspinal surgery during the last 3 months
• • 9. Gastrointestinal malignancy or gastrointestinal bleeding within 21 days
• • 10. Known bleeding diatheses; platelets count \< 100000/mm3, international normalized ratio \> 1.7, prothrombin time \> 15 s, or activated partial thromboplastin clotting time \> 40 s
• • 11. Treatment with a full dosage of low-molecular weighted heparin in the last 24 hours
• • 12. Treatment with direct thrombin inhibitors or direct factor Xa inhibitors within the previous 48 hours unless the laboratory test of coagulation function is normal
• • 13. Initial systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥100 mmHg
• • 14. Initial glucose levels \<2.8 or 22.22 mmol/L
• • 15. Known or suspected aortic arch dissection
• In addition to:
• • 1. Clinical presentation or imaging profile consistent with Moyamoya disease/syndrome.
• • 2. Pregnancy or breastfeeding.
• • 3. Recent participation in another investigational drug or device study or registry in the past 30 days before enrollment.
• • 4. Any terminal illness such that the patient would not be expected to survive more than three months.
• • 5. Other conditions in which investigators believe that participating in this study may be harmful to the patient.