CHinese ischEmic Stroke Beyond 4.5 Hours With TeNecteplase Under Optimized Non-Contrast CT
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
| Condition(s) | Acute Ischemic Stroke |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| 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. |
| Who can participate | 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 t |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Huashan Hospital |
| Locations | Shanghai, Shanghai Municipality, China; Shanghai, China |
| Start date | 2025-11-03 |
| NCT ID | NCT06994975 |
| Official listing | https://clinicaltrials.gov/study/NCT06994975 |