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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

890 Participants
are divided into 2 treatment groups
Group A: 0.25mg/kg TNK groupExperimental treatment 1 intervention
Group B: Standard medical treatmentPlacebo comparator 1 intervention

Trial outcomes

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.

Time frame
at 90±7 days

Secondary outcomes

1

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

The secondary radiological efficacy outcome is infarct growth, defined as the difference in volume between the infarct volume measured by diffusion-weighted imaging (DWI) or non-contrast head CT at 3-5 days and the baseline core infarct volume.

Time frame
at 3-5 days
2

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

The secondary clinical efficacy outcome is the proportion of participants achieving good functional outcome (functional independence, defined as a modified Rankin Scale \[mRS\] score of 0-2) at 90±7 days.

Time frame
at 90±7 days
3

Distribution of Modified Rankin Scale Scores at 90±7 Days

The secondary clinical efficacy outcome is the distribution of modified Rankin Scale (mRS) scores from 0 (no symptoms) to 6 (death) at 90±7 days post-treatment.

Time frame
at 90±7 days
4

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

The secondary clinical efficacy outcome is the proportion of participants achieving significant neurological improvement within 24-48 hours, defined as a reduction in National Institutes of Health Stroke Scale (NIHSS) score by more than 8 points or an NIHSS score of 0-1.

Time frame
within 24-48 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Huashan Hospital

Lead sponsor

Source ClinicalTrials.gov
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