CHinese ischEmic Stroke Beyond 4.5 Hours With TeNecteplase Under Optimized Non-Contrast CT Selection
Trial Parameters
Brief 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 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 N