Acute ischemic non-macrovascular occlusive stroke
Conditions
Interventions
Intravenous thrombolytic therapy group:Tenecteplase 0.25 mg/kg, dissolved in sterile water for injection, administered as a single intravenous bolus, followed by basic treatment after thrombolysis.
control group:Non-thrombolytic therapy, standard medical treatment.
Sponsors
Mianyang Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 80 years; 2. Acute ischemic stroke with symptom onset between 4.5 and 9 hours; 3. Imaging assessment: Presence of a DWI-FLAIR mismatch on brain MRI (DWI-FLAIR mismatch is defined as a DWI hyperintense lesion in which the corresponding region on FLAIR is interpreted as negative; if both DWI and FLAIR show positive signals in the same lesion area, it is considered a DWI-FLAIR match); 4. Pre-stroke modified Rankin Scale (mRS) score = 5; 6. The patient or the patient’s legally authorized representative is able and willing to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Large vessel occlusion confirmed by cranial CTA, MRA, or DSA (Note: Large vessels are defined as the internal carotid artery \[ICA] including both extracranial and intracranial segments, vertebral artery \[VA] segments V1–V4, basilar artery \[BA], posterior cerebral artery \[PCA] segment P1, anterior cerebral artery \[ACA] segment A1, and middle cerebral artery \[MCA] segments M1 and M2); 2. History of severe central nervous system disorders (e.g., tumor, aneurysm, arteriovenous malformation, traumatic brain injury, intracranial or spinal surgery, etc.); 3. Seizure at stroke onset with suspected paralysis related to Todd’s paresis; 4. Use of heparin within 48 hours prior to onset, with APTT exceeding the upper limit of the laboratory reference range; 5. Use of oral anticoagulants (e.g., warfarin) with INR > 1.7 or PT > 15 seconds; 6. Use of thrombin inhibitors or factor Xa inhibitors within 48 hours prior to onset, along with abnormal coagulation parameters or platelet counts; 7. Uncontrolled hypertension despite active antihypertensive treatment, defined as systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg on three repeated measurements at intervals of at least 10 minutes; 8. Patients scheduled to receive endovascular treatment (within 90 days); 9. Platelet count 400 mg/dL (22.2 mmol/L); 11. History of intracranial hemorrhage or active bleeding disorders (e.g., gastrointestinal, urinary tract, or retinal hemorrhage); 12. Tumors with increased risk of bleeding; 13. Prolonged or traumatic cardiopulmonary resuscitation (>2 minutes), delivery within the past 10 days, or recent puncture of non-compressible vessels (e.g., subclavian or jugular veins); 14. Acute pancreatitis or severe liver disease, including hepatic failure, cirrhosis, portal hypertension, esophageal varices, or active hepatitis; 15. Aortic dissection; 16. Major surgery or severe trauma within the past 2 weeks; 17. Presence of severe, fatal, or disabling disease with a life expectancy of less than 3 months; 18. Known dementia or psychiatric illness that precludes accurate neurological assessment or follow-up; 19. Pregnancy, lactation, or a positive pregnancy test; 20. Known hypersensitivity to tenecteplase, alteplase, or any of their components; 21. Participation in another drug or device clinical trial within the past 3 months; 22. Deemed unsuitable for study enrollment by the investigator or considered at increased risk due to participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects with mRS 0-1 points at 90 days;24-hour incidence of symptomatic intracranial hemorrhage;All-cause mortality within 90 days; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects with mRS 0-2 points at 90 days;90-day mRS level distribution;Incidence of asymptomatic intracranial hemorrhage within 24 hours; | — |
Countries
China
Contacts
Public ContactTang Yufeng
Mianyang Central Hospital
Outcome results
None listed