Tenecteplase for ischemic stroke given after 4.5 hours when CT shows a small infarct

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

CHESTNUT is a multicenter, open-label, blinded-endpoint, randomized phase 3 trial comparing one 0.25 mg/kg intravenous dose of tenecteplase to standard medical treatment in Chinese patients with acute anterior-circulation ischemic stroke who are beyond 4.5 hours and are not candidates for endovascular thrombectomy. Eligible patients are selected using automated non-contrast CT post-processing to ensure infarct core volume is less than 50 mL and there is no visible hypodensity in more than one-third of the MCA territory. Participants are randomized 1:1 and followed with blinded assessment of clinical outcomes, with primary efficacy and safety measured at 90 days. The protocol emphasizes standardized NCCT selection and centralized outcome adjudication to minimize bias.

Why it matters

Who can join: the full rules

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.

Where it's running

• Huashan Hospital
  Shanghai, Shanghai Municipality, China Recruiting
• Huashan Hospital, Fudan University
  Shanghai, China Not yet recruiting

Study contacts

• Study coordinator: Xin Cheng, MD, PhD
• Email: chengxin@fudan.edu.cn
• Phone: +86 021-52887145

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.