NCT06994975 CHinese ischEmic Stroke Beyond 4.5 Hours With TeNecteplase Under Optimized Non-Contrast CT Selection
| NCT ID | NCT06994975 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Huashan Hospital |
| Condition | Acute Ischemic Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 890 participants |
| Start Date | 2025-11-03 |
| Primary Completion | 2028-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 890 participants in total. It began in 2025-11-03 with a primary completion date of 2028-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06994975 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Ischemic Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06994975 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 890 participants.
Is NCT06994975 currently recruiting?
Yes, NCT06994975 is actively recruiting participants. Contact the research team at chengxin@fudan.edu.cn for enrollment information.
Where is the NCT06994975 trial being conducted?
This trial is being conducted at Shanghai, China, Shanghai, China.
Who is sponsoring the NCT06994975 clinical trial?
NCT06994975 is sponsored by Huashan Hospital. The trial plans to enroll 890 participants.
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