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

NCT06994975 | Recruiting Phase 3 DMC

• 1 other identifier: KY2025-720
• Study Type: interventional
• Target: 890
• Locations: 1 country
• Sites: 2

Brief Summary

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

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants Achieving Excellent Functional Outcome (mRS 0-1) at 90±7 Days

  The primary outcome is the proportion of participants achieving excellent functional outcome (free of disability, defined as a modified Rankin Scale \[mRS\] score of 0-1) at 90±7 days.

  at 90±7 days

Secondary Outcomes (11)

• Infarct Growth Volume at 3-5 Days Compared to Baseline Core

  at 3-5 days

• Proportion of Participants Achieving Good Functional Outcome (mRS 0-2) at 90±7 Days

  at 90±7 days

• Distribution of Modified Rankin Scale Scores at 90±7 Days

  at 90±7 days

• Proportion of Participants with Significant Neurological Improvement within 24-48 Hours

  within 24-48 hours

• Change in NIHSS Score at 24-48 Hours

  at 24-48 hours

Study Arms (2)

0.25mg/kg TNK group

EXPERIMENTAL

Drug: 0.25mg/kg TNK

Standard medical treatment

PLACEBO COMPARATOR

Drug: Standard medical treatment

Interventions

0.25mg/kg TNK DRUG

Patients in the tenecteplase group were administered a 0.25mg/kg dose as a bolus over 5-10 seconds, followed by a 2 mL saline flush.

0.25mg/kg TNK group

Standard medical treatment DRUG

Patients in the standard medical treatment group will receive the standard treatment selected by local doctors, including antithrombotic agents, lipid-lowering agents, antihypertensive drugs, and hypoglycemic agents. Patients would be ineligible if bridging endovascular treatment is planned at the time of randomization.

Standard medical treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Huashan Hospital: lead

Study Sites (2)

Huashan Hospital

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

Huashan Hospital, Fudan University

Shanghai, China

NOT YET RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Xin Cheng, MD, PhD

CONTACT

+86 021-52887145; chengxin@fudan.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinded-endpoint
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Vice Chair, Department of Neurology, Huashan Hospital, Fudan University

Model Details: Multicenter, open-label, blinded-endpoint, randomized, controlled, phase 3 trial

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: May 29, 2025
• Study Start: November 3, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

CN (2)