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Clinical Trials in China / NCT06994975
Recruiting Phase 3

CHinese ischEmic Stroke Beyond 4.5 Hours With TeNecteplase Under Optimized Non-Contrast CT Selection

NCT06994975 · tracked via the Priya Life Science China tracker
Sponsor
Huashan Hospital
Phase
Phase 3
Started
2025-11-03
Last updated
2025-12-30

Condition(s) studied

Acute Ischemic Stroke

Investigational drug(s) / intervention(s)

0.25mg/kg TNKStandard medical treatment

0.25mg/kg TNK: Patients in the tenecteplase group were administered a 0.25mg/kg dose as a bolus over 5-10 seconds, followed by a 2 mL saline flush.

Standard medical treatment: Patients in the standard medical treatment group will receive the standard treatment selected by local doctors, including antithrombotic agents, lipid-lowering agents, antihypertensive drugs, and hypoglycemic agents. Patients would be ineligible if bridging endovascular treatment is planned at the time of randomization.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 NCCT 6. History of any intracranial hemorrhage 7. History of ischemic stroke or major head trauma within the last 3 months 8. History of intracranial/intraspinal surgery during the last 3 months 9. Gastrointestinal malignancy or gastrointestinal bleeding within 21 days 10. Known bleeding diatheses; platelets count \< 100000/mm3, international normalized ratio \> 1.7, prothrombin time \> 15 s, or activated partial thromboplastin clotting time \> 40 s 11. Treatment with a full dosage of low-molecular weighted heparin in the last 24 hours 12. Treatment with direct thrombin inhibitors or direct factor Xa inhibitors within the previous 48 hours unless the laboratory test of coagulation function is normal 13. Initial systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥100 mmHg 14. Initial glucose levels \<2.8 or 22.22 mmol/L 15. Known or suspected aortic arch dissection In addition to: 1. Clinical presentation or imaging profile consistent with Moyamoya disease/syndrome. 2. Pregnancy or breastfeeding. 3. Recent participation in another investigational drug or device study or registry in the past 30 days before enrollment. 4. Any terminal illness such that the patient would not be expected to survive more than three months. 5. Other conditions in which investigators believe that participating in this study may be harmful to the patient.

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Huashan Hospital Shanghai Shanghai Municipality Recruiting
Huashan Hospital, Fudan University Shanghai China Not Yet Recruiting

More Huashan Hospital trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06994975 on ClinicalTrials.gov ↗ ← All trials in China