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RECRUITING
NCT06994975
PHASE3

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

Sponsor: Huashan Hospital

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

890

Start Date

2025-11-03

Completion Date

2028-06

Last Updated

2025-12-30

Healthy Volunteers

No

Interventions

DRUG

0.25mg/kg TNK

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.

DRUG

Standard medical treatment

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.

Locations (2)

Huashan Hospital

Shanghai, Shanghai Municipality, China

Huashan Hospital, Fudan University

Shanghai, China