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

Fudan University

Status and phase

Enrolling

Phase 3

Conditions

Acute Ischemic Stroke

Treatments

Drug: Standard medical treatment

Drug: 0.25mg/kg TNK

Study type

Interventional

Funder types

Other

Identifiers

NCT06994975

KY2025-720

Details and patient eligibility

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.

Full description

CHinese ischEmic Stroke beyond 4.5 Hours with TeNecteplase Under optimized Non-Contrast CT selection (CHESTNUT) is a multicenter, open-label, blinded-endpoint, randomized, controlled, phase 3 study. Patients with acute strokes who are unable to undergo endovascular thrombectomy and exhibit no substantial infarction lesion on non-contrast computed tomography (less than 50 mL according to the automated NCCT post-processing model and no visible hypodensity in more than 1/3 of the middle cerebral artery [MCA] territory) are randomly assigned in a 1:1 ratio to receive either 0.25 mg/kg TNK or standard medical treatment. The efficacy and safety of 0.25 mg/kg TNK are assessed through clinical prognosis at 90 days.

Enrollment

890 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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
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
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 a full dosage of low-molecular weighted heparin in the last 24 hours
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 systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥100 mmHg
Initial glucose levels <2.8 or 22.22 mmol/L
Known or suspected aortic arch dissection

In addition to:

Clinical presentation or imaging profile consistent with Moyamoya disease/syndrome.
Pregnancy or breastfeeding.
Recent participation in another investigational drug or device study or registry in the past 30 days before enrollment.
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.