Branch Atheromatous Disease
Conditions
Sponsors
The First People's Hospital of Foshan
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. NIHSS score of 1-10 at screening, and level of consciousness (NIHSS 1a) = 2 consecutive axial DWI slices (slice thickness 4-5 mm); or (b) Maximum axial diameter >= 15 mm at the slice with the largest lesion; In addition, there should be no cortical involvement. B. PPA-BAD phenotype (at least one of the following must be met): (a) Involvement of >= 2 consecutive axial DWI slices (slice thickness 4-5 mm); or (b) Maximum axial diameter >= 15 mm at the slice with the largest lesion; or (c) The lesion abuts the ventral surface of the pons (suggesting ostial involvement of a basilar artery perforator). Note: In addition, there must be no cortical involvement, and basilar artery occlusion and other definite large-vessel mechanisms must be excluded. Final imaging inclusion eligibility is determined by blinded adjudication of the imaging core laboratory. When conditions permit, vascular imaging (CTA or MRA) is recommended to exclude definite large-artery mechanisms and characterize parent artery plaque/stenosis; however, the inability to directly visualize perforator ostial lesions is not a necessary condition for exclusion from enrollment. Final imaging inclusion eligibility is reviewed and adjudicated blindly by the imaging core laboratory. If the judgment of the study site is inconsistent with that of the core laboratory, the core laboratory's adjudication shall prevail. 6. Randomization and first dosing should be initiated within 24 hours from the target onset or last known well (LKW) time, and baseline MRI must be completed before randomization to ensure intervention within the acute-phase intervention window. The onset time should be accurately provided by the patient or family members and clearly documented in the medical record. 7. General health status: Subjects must have a relatively good overall health status. Specific requirements are as follows: cardiac, hepatic, and renal function normal or mildly impaired, but not affecting drug metabolism or excretion; no other serious complications, such as active malignancy, uncontrolled diabetes, severe heart disease (heart failure, myocardial infarction), etc.; no history of psychiatric disorders, or mild psychiatric disorders that have been stabilized after treatment. 8. Laboratory test results: B
Exclusion criteria
Exclusion criteria: Neurological and Stroke-Related Exclusion Criteria 1. NIHSS score >10 at screening. 2. Single small subcortical infarct that does not meet the prespecified LSA/PPA BAD phenotype imaging criteria (more consistent with classic lacunar infarct due to small-vessel lipohyalinosis), as adjudicated by the imaging core laboratory. 3. Thalamic lacunar infarct in the territory supplied by thalamic perforating arteries. 4. MRI suggesting cortical infarct or multiple ischemic lesions. 5. Imaging evidence of >=50% stenosis or occlusion of the parent artery supplying the ipsilateral responsible lesion (e.g., MCA M1, basilar artery, PCA P1, etc. consistent with the infarct distribution), or findings suggesting a definite large-vessel mechanism. 6. Pure lacunar infarct with no evidence of responsible artery plaque. 7. History of prior intracranial hemorrhage, aneurysm, or arteriovenous malformation. 8. Clinical diagnosis of cardioembolic stroke (e.g., atrial fibrillation, artificial heart valve, endocarditis, left atrial thrombus, etc.). 9. Received intravenous thrombolysis or endovascular therapy within 24 hours before randomization. 10. Prior severe disability (pre-stroke mRS >=2). Systemic Disease-Related Exclusion Criteria 11. Known severe hepatic impairment (alanine aminotransferase or aspartate aminotransferase >3 times the upper limit of normal [ULN], or total bilirubin >2×ULN). 12. Known severe renal impairment (eGFR 2.0 mg/dL). 13. Congestive heart failure (NYHA class III-IV), severe chronic obstructive pulmonary disease, or other diseases that may interfere with study results. 14. Active peptic ulcer disease, gastrointestinal bleeding, or major surgery within the past 3 months. 15. Known malignancy with an expected survival of 1.5 (not due to anticoagulation reversal therapy). Contraindications to Edaravone Dexborneol 24. Patients with severe renal failure (at risk of worsening renal failure). 25. History of allergy to this product. Other Exclusion Criteria 26. Any terminal illness with an expected survival of no more than 1 year. 27. Any other condition, other than the above exclusion criteria, judged by the investigator to potentially endanger the subject's safety or affect compliance/endpoint assessment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| calculating the percentage change in infarct volume; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in NIHSS score at Day 10 (±2 days);Early Neurological Deterioration;mRS score change at Day 90;Recurrent stroke within 90 days after randomization;Early Neurological Deterioration;Day10±2 absolute infarct volume (mL, ICV corrected);Infarct expansion =30% (binary variable, defined by the ratio of V10 to V0); | — |
Countries
China
Contacts
Public ContactTan Zefeng
The First People's Hospital of Foshan
Outcome results
None listed