Tests tenecteplase dose for stroke patients treated after 4.5 hours
Tests a lower tenecteplase dose in adults with ischemic stroke beyond 4.5 hours.
Plain-language title generated from the registry record
Registry title: CHinese ischEmic Stroke Beyond 4.5 Hours With TeNecteplase Under Optimized Non-Contrast CT Selection
Key facts
- Where
- Shanghai, ChinaSee the 2 sites
- Phase
- Phase 3
Where in China
- Huashan HospitalShanghai, ChinaTaking people
- Huashan Hospital, Fudan UniversityShanghai, ChinaNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Huashan Hospital
- Trial code
- NCT06994975
- Record updated
- 30 December 2025
- Original description
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.Read full original descriptionShow less
CHinese ischEmic Stroke Beyond 4.5 Hours With TeNecteplase Under Optimized Non-Contrast CT Selection
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.
Inclusion: 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: Treatment with a full dosage of low-molecular weighted heparin in the last 24 hours; Recent participation in another investigational drug or device study or registry in the past 30 days before enrollment; Obvious hypodensity on NCCT deemed related with the current stroke event, with no expected benefit from thrombolysis as assessed by the investigators; Allergy to the test drug and its ingredients; 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; Clinical presentation or imaging profile consistent with Moyamoya disease/syndrome; 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; 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 direct thrombin inhibitors or direct factor Xa inhibitors within the previous 48 hours unless the laboratory test of coagulation function is normal; Initial glucose levels <2.8 or 22.22 mmol/L; Endovascular thrombectomy (EVT) planned at the time of randomization; Rapidly improving symptoms at the discretion of the investigator; Initial systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥100 mmHg; Known or suspected aortic arch dissection; In addition to:; Pregnancy or breastfeeding.