CHinese ischEmic Stroke Beyond 4.5 Hours With TeNecteplase Under Optimized Non-Contrast CT Selection
ConditionAcute Ischemic Stroke
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorHuashan Hospital
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.
Eligibility criteria
Qualifiers
Suspected acute ischemic stroke of anterior cerebral circulation.
Last known well time >4.5 hours.
Age ≥18 years old.
Baseline NIHSS (National Institutes of Health Stroke Scale) score >5.
Disqualifiers
Obvious hypodensity on NCCT deemed related with the current stroke event, with no expected benefit from thrombolysis as assessed by the investigators
Endovascular thrombectomy (EVT) planned at the time of randomization
Allergy to the test drug and its ingredients
Rapidly improving symptoms at the discretion of the investigator
Trial design
Treatments tested in this trial
- 0.25mg/kg TNK
- Standard medical treatment
Treatment groups
890 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov