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NCT06994975RecruitingPhase 3

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

Source: ClinicalTrials.gov · Last updated 30 Dec 2025

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
890 (estimated)
First submitted
20 May 2025
Start date
3 Nov 2025
Primary completion date
Mar 2028
Lead sponsor
Huashan Hospital
Diseases
Stroke
NCT number
NCT06994975

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 890
  • From 3 Nov 2025 to the primary completion date, Mar 2028
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Treatment with a full dosage of low-molecular weighted heparin in the last 24 hours
  • Recent participation in another investigational drug or device study or registry in the past 30 days before enrollment.

Other illness

  • Obvious hypodensity on NCCT deemed related with the current stroke event, with no expected benefit from thrombolysis as assessed by the investigators
  • Allergy to the test drug and its ingredients
  • Any sign of an acute intracranial hemorrhage or subarachnoid hemorrhage identified on baseline NCCT
  • History of any intracranial hemorrhage
  • History of ischemic stroke or major head trauma within the last 3 months
  • History of intracranial/intraspinal surgery during the last 3 months
  • Gastrointestinal malignancy or gastrointestinal bleeding within 21 days
  • Clinical presentation or imaging profile consistent with Moyamoya disease/syndrome.
  • Any terminal illness such that the patient would not be expected to survive more than three months.
  • Other conditions in which investigators believe that participating in this study may be harmful to the patient.

Lab values

  • Known bleeding diatheses; platelets count \< 100000/mm3, international normalized ratio \> 1.7, prothrombin time \> 15 s, or activated partial thromboplastin clotting time \> 40 s
  • Treatment with direct thrombin inhibitors or direct factor Xa inhibitors within the previous 48 hours unless the laboratory test of coagulation function is normal
  • Initial glucose levels \<2.8 or 22.22 mmol/L

Other

  • Endovascular thrombectomy (EVT) planned at the time of randomization
  • Rapidly improving symptoms at the discretion of the investigator
  • Initial systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥100 mmHg
  • Known or suspected aortic arch dissection
    • In addition to:
  • Pregnancy or breastfeeding.

Who the study is looking for

  • 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.
  • Premorbid modified Rankin Scale (mRS) ≤1.
  • 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.
  • Informed consent signed by the patient or the patient's legally authorized representative.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Huashan Hospital, Fudan University
Coordinator of this site? Confirm its status
ShanghaiChinaNot yet recruiting
Huashan Hospital
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.