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

Recruiting Phase 3 Interventional Study
Acute Ischemic Stroke
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
890 (estimated)
Sponsor
Huashan Hospital · Other
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About This Trial

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.

Trial Locations
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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 i…
Contacts

Xin Cheng, MD, PhD

+86 021-52887145

chengxin@fudan.edu.cn

CONTACT