CHinese ischEmic Stroke Beyond 4.5 Hours With TeNecteplase Under Optimized Non-Contrast CT Selection
Huashan Hospital
890 participants
Nov 3, 2025
INTERVENTIONAL
Conditions
Summary
The CHESTNUT trial is a multicenter, open-label, blinded-endpoint, randomized, controlled, phase 3 trial. The primary objective of this study is to explore the efficacy and safety of the dose of 0.25 mg/kg tenecteplase (TNK) in Chinese acute ischemic stroke (AIS) patients without substantial infarction on non-contrast computed tomography (NCCT) in an extended time window.
Eligibility
Inclusion Criteria7
- Suspected acute ischemic stroke of anterior cerebral circulation.
- Last known well time >4.5 hours.
- Age ≥18 years old.
- Baseline NIHSS (National Institutes of Health Stroke Scale) score >5.
- Premorbid modified Rankin Scale (mRS) ≤1.
- 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.
- Informed consent signed by the patient or the patient's legally authorized representative.
Exclusion Criteria21
- Obvious hypodensity on NCCT deemed related with the current stroke event, with no expected benefit from thrombolysis as assessed by the investigators
- Endovascular thrombectomy (EVT) planned at the time of randomization
- Allergy to the test drug and its ingredients
- Rapidly improving symptoms at the discretion of the investigator
- Any sign of an acute intracranial hemorrhage or subarachnoid hemorrhage identified on baseline NCCT
- History of any intracranial hemorrhage
- History of ischemic stroke or major head trauma within the last 3 months
- History of intracranial/intraspinal surgery during the last 3 months
- Gastrointestinal malignancy or gastrointestinal bleeding within 21 days
- Known bleeding diatheses; platelets count < 100000/mm3, international normalized ratio > 1.7, prothrombin time > 15 s, or activated partial thromboplastin clotting time > 40 s
- Treatment with a full dosage of low-molecular weighted heparin in the last 24 hours
- Treatment with direct thrombin inhibitors or direct factor Xa inhibitors within the previous 48 hours unless the laboratory test of coagulation function is normal
- Initial systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥100 mmHg
- Initial glucose levels <2.8 or 22.22 mmol/L
- Known or suspected aortic arch dissection
- In addition to:
- Clinical presentation or imaging profile consistent with Moyamoya disease/syndrome.
- Pregnancy or breastfeeding.
- Recent participation in another investigational drug or device study or registry in the past 30 days before enrollment.
- Any terminal illness such that the patient would not be expected to survive more than three months.
- Other conditions in which investigators believe that participating in this study may be harmful to the patient.
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Interventions
Patients in the tenecteplase group were administered a 0.25mg/kg dose as a bolus over 5-10 seconds, followed by a 2 mL saline flush.
Patients in the standard medical treatment group will receive the standard treatment selected by local doctors, including antithrombotic agents, lipid-lowering agents, antihypertensive drugs, and hypoglycemic agents. Patients would be ineligible if bridging endovascular treatment is planned at the time of randomization.
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT06994975