Status:
RECRUITING
CHinese ischEmic Stroke Beyond 4.5 Hours With TeNecteplase Under Optimized Non-Contrast CT Selection
Lead Sponsor:
Huashan Hospital
Conditions:
Acute Ischemic Stroke
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
Detailed Description
CHinese ischEmic Stroke beyond 4.5 Hours with TeNecteplase Under optimized Non-Contrast CT selection (CHESTNUT) is a multicenter, open-label, blinded-endpoint, randomized, controlled, phase 3 study. P...
Eligibility Criteria
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
- 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.
Key Trial Info
Start Date :
November 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
890 Patients enrolled
Trial Details
Trial ID
NCT06994975
Start Date
November 3 2025
End Date
June 1 2028
Last Update
December 30 2025
Active Locations (2)
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1
Huashan Hospital
Shanghai, Shanghai Municipality, China, 200040
2
Huashan Hospital, Fudan University
Shanghai, China