CHinese ischEmic Stroke Beyond 4.5 Hours With TeNecteplase Under Optimized Non-Contrast CT Selection
NCT ID: NCT06994975
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
890 participants
INTERVENTIONAL
2025-11-03
2028-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
0.25mg/kg TNK group
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.
Standard medical treatment
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Last known well time \>4.5 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
2. Endovascular thrombectomy (EVT) planned at the time of randomization
3. Allergy to the test drug and its ingredients
4. Rapidly improving symptoms at the discretion of the investigator
5. Any sign of an acute intracranial hemorrhage or subarachnoid hemorrhage identified on baseline NCCT
6. History of any intracranial hemorrhage
7. History of ischemic stroke or major head trauma within the last 3 months
8. History of intracranial/intraspinal surgery during the last 3 months
9. Gastrointestinal malignancy or gastrointestinal bleeding within 21 days
10. Known bleeding diatheses; platelets count \< 100000/mm3, international normalized ratio \> 1.7, prothrombin time \> 15 s, or activated partial thromboplastin clotting time \> 40 s
11. Treatment with a full dosage of low-molecular weighted heparin in the last 24 hours
12. Treatment with direct thrombin inhibitors or direct factor Xa inhibitors within the previous 48 hours unless the laboratory test of coagulation function is normal
13. Initial systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥100 mmHg
14. Initial glucose levels \<2.8 or 22.22 mmol/L
15. 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Huashan Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Xin Cheng
Professor and Vice Chair, Department of Neurology, Huashan Hospital, Fudan University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Huashan Hospital
Shanghai, Shanghai Municipality, China
Huashan Hospital, Fudan University
Shanghai, , China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Wei Huang
Role: primary
Xin Cheng, MD, PhD
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
KY2025-720
Identifier Type: -
Identifier Source: org_study_id