CHinese Acute Tissue-Based Imaging Selection for Lysis In Stroke -Non-contrast CT Based EXtended Window Thrombolysis

Phase 3

Not yet recruiting

• Conditions: Acute Ischemic Stroke
• Interventions: Drug: 0.25mg/kg TNK; Drug: Standard medical treatment

• Registration Number: NCT06994975
• Lead Sponsor: Huashan Hospital

Brief Summary

The CHABLIS-NEXT 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 TNK in Chinese AIS patients without substantial infarction on NCCT in an extended time window.

Detailed Description

CHinese Acute tissue-Based imaging selection for Lysis In Stroke-Non-contrast CT based EXtended window Thrombolysis (CHABLIS-NEXT) 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 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.

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-05-20
• Study First Submitted QC: 2025-05-20
• Last Update Submitted: 2025-05-20
• Study First Posted: 2025-05-29
• Last Update Posted: 2025-05-29
• Study Start: 2025-06
• Primary Completion: 2027-11
• Study Completion: 2027-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 890

Inclusion Criteria

1. Suspected acute ischemic stroke of anterior cerebral circulation.
2. Last known well time >4.5 hours and ≤24 hours.
3. Age ≥18 years old.
4. Baseline NIHSS (National Institutes of Health Stroke Scale) score >5.
5. Premorbid modified Rankin Scale (mRS) ≤1.
6. 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.
7. Informed consent signed by the patient or the patient's legally authorized representative.

Exclusion Criteria

1. Endovascular thrombectomy (EVT) planned at the time of randomization.
2. Allergy to the test drug and its ingredients.
3. Rapidly improving symptoms at the discretion of the investigator, which may indicate spontaneous recanalization.
4. Any sign of an acute intracranial hemorrhage or subarachnoid hemorrhage identified on baseline NCCT.
5. History of any intracranial hemorrhage.
6. History of ischemic stroke or major head trauma within the last 3 months.
7. History of intracranial/intraspinal surgery during the last 3 months.
8. Gastrointestinal malignancy or gastrointestinal bleeding within 21 days.
9. Known bleeding diatheses; platelets count < 100000/mm3, international normalized ratio > 1.7, prothrombin time > 15 s, or activated partial thromboplastin clotting time > 40 s.
10. Treatment with a full dosage of low-molecular weighted heparin in the last 24 hours.
11. Treatment with direct thrombin inhibitors or direct factor Xa inhibitors within the previous 48 hours unless the laboratory test of coagulation function is normal.
12. Initial systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥100 mmHg.
13. Initial glucose levels <2.8 or 22.22 mmol/L.
14. Known or suspected aortic arch dissection.

In addition to:

1. Clinical presentation or imaging profile consistent with Moyamoya disease/syndrome.
2. Pregnancy or breastfeeding.
3. Recent participation in another investigational drug or device study or registry in the past 30 days before enrollment.
4. Any terminal illness such that the patient would not be expected to survive more than three months.
5. Other conditions in which investigators believe that participating in this study may be harmful to the patient.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.25mg/kg TNK group	0.25mg/kg TNK	-
Standard medical treatment	Standard medical treatment	-

Primary Outcome Measures

Name	Time	Method
Efficacy Outcome	at 90±7 days	The primary outcome is the excellent functional outcome (free of disability, defined as mRS 0-1) at 90±7 days.

Secondary Outcome Measures

Name	Time	Method
Secondary radiological efficacy outcomes	at 3-5 days	Infarct growth defined by the difference of volume between the infarct volume at DWI (diffusion-weighted imaging)/ non-contrast head CT at 3-5 days and baseline core.
Secondary clinical efficacy outcomes	at 24-48 hours	Change in NIHSS as a continuous variable at 24-48 hours
Secondary radiological safety outcomes	at 24-48 hours	Type 2 parenchymal hematoma (PH2) at 24-48 hours post treatment
Secondary clinical safety outcomes	within 90 days	Systemic bleeding defined by The Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO) within 90 days

Trial Locations

Locations (1)

Huashan Hospital, Fudan University; 🇨🇳 Shanghai, China