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
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with a suspected stroke caused by a blocked blood vessel, who arrive more than 4.5 hours after they were last known well. It tests the clot-dissolving drug tenecteplase (TNK) at 0.25 mg/kg.
- Age
- 18 years or older
- Sex
- Men and women can join.
- Disease stage
- Suspected acute ischemic stroke in the front part of the brain's blood supply. NIHSS score above 5. A non-contrast CT scan must show a small area of damaged brain tissue (infarct core under 50 mL) and no visible dark area in more than 1/3 of the MCA territory.
- Earlier treatment
- Before the stroke, the person must have had a modified Rankin Scale score of 1 or less. Cannot join with full-dose low-molecular weight heparin in the last 24 hours, or direct thrombin or factor Xa inhibitors in the last 48 hours unless clotting tests are normal.
Main reasons for not taking part
- Thrombectomy (clot removal) planned at the time of randomization
- Any sign of bleeding in the brain on the first CT scan, or a past brain bleed
- Ischemic stroke, major head injury or brain or spinal surgery in the last 3 months
- Known bleeding disorder, or blood tests outside the limits set in the record
- Pregnancy or breastfeeding
Read by machine on 12 November 2026.
Where in China
- Huashan HospitalShanghai, ChinaContact: Wei HuangTaking people
- Huashan Hospital, Fudan UniversityShanghai, ChinaContact: Xin Cheng, MD, PhDNot 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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.