Actively Recruiting
CHinese ischEmic Stroke Beyond 4.5 Hours With TeNecteplase Under Optimized Non-Contrast CT Selection
Led by Huashan Hospital · Updated on 2025-12-30
890
Participants Needed
2
Research Sites
134 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
CHinese ischEmic Stroke Beyond 4.5 Hours With TeNecteplase Under Optimized Non-Contrast CT Selection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Suspected acute ischemic stroke of anterior cerebral circulation
- Last known well time >4.5 hours
- Age 18 years or older
- Baseline NIHSS score greater than 5
- Premorbid modified Rankin Scale (mRS) 1 or less
- Infarct core volume less than 50 mL on automated NCCT post-processing and no visible hypodensity in more than one-third of the middle cerebral artery territory
- Informed consent signed by patient or legally authorized representative
You will not qualify if you...
- Obvious hypodensity on NCCT related to current stroke with no expected benefit from thrombolysis
- Planned endovascular thrombectomy at time of randomization
- Allergy to tenecteplase or its ingredients
- Rapidly improving symptoms
- Any sign of acute intracranial or subarachnoid hemorrhage on baseline NCCT
- History of intracranial hemorrhage
- History of ischemic stroke or major head trauma within last 3 months
- History of intracranial or intraspinal surgery within last 3 months
- Gastrointestinal malignancy or bleeding within 21 days
- Known bleeding disorders or abnormal blood clotting tests
- Treatment with full-dose low-molecular-weight heparin within last 24 hours
- Treatment with direct thrombin or factor Xa inhibitors within previous 48 hours unless coagulation tests are normal
- Initial systolic blood pressure 180 mmHg or higher or diastolic 100 mmHg or higher
- Initial glucose levels below 2.8 or above 22.22 mmol/L
- Known or suspected aortic arch dissection
- Clinical or imaging signs of Moyamoya disease or syndrome
- Pregnancy or breastfeeding
- Participation in another investigational drug or device study within past 30 days
- Terminal illness with expected survival less than three months
- Other conditions judged by investigators to make participation harmful
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Huashan Hospital
Shanghai, Shanghai Municipality, China, 200040
Actively Recruiting
2
Huashan Hospital, Fudan University
Shanghai, China
Not Yet Recruiting
Research Team
X
Xin Cheng, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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