Stroke, Ischemic
Conditions
Keywords
Endovascular therapy, Extended Time Windows
Brief summary
To explore the safety and efficacy of edaravone dexborneol for patients of acute ischemic stroke received endovascular therapy in extended time windows.
Interventions
Intravenous injections of edaravone dexborneol (37.5mg in 0·9% NaCl) BID for 7-14days.
Sponsors
First Affiliated Hospital Xi'an Jiaotong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. 18 to 80 years of age; 2. Acute ischemic stroke with National Institute of Health Stroke Scale (NIHSS) ≥ 10 and Volume of infarction on DWI \<31ml or with a NIHSS ≥20 and 31ml\<Volume of infarction\<51ml(DWI); 3. Patients who presented with acute ischemic stroke and a large vessel occlusion in the anterior circulation; 4. Endovascular Therapy in 6-24 hours of stroke onset; 5. The availability of informed consent.
Exclusion criteria
1. First ever stroke or mRS≤1 after previous disease; 2. Hemorrhagic stroke: cerebral hemorrhage, subarachnoid hemorrhage; 3. Coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia 4. Severe hepatic or renal dysfunction, increase in ALT or AST (more than 2 times of upper limit of normal value), increase in serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis; 5. Severe cardiac or pulmonary disease; 6. Patients with malignant tumor or under antineoplastic therapy with estimated lifetime less than 3 months; 7. Pregnancy, plan to get pregnant or during lactation; 8. Patients with contraindication or allergic to any ingredient of drugs in our study; 9. Unsuitable for this clinical studies assessed by researcher
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with modified Rankin Score 0 to 3 on day 90 | 90 days |
| Proportion of symptomatic intracranial hemorrhage (sICH) | 48 hours |
| mTICI grade (<2 b、≥2 b) stratified for primary outcome analysis | 90 days |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of patients with Barthel Index (BI) score greater than or equal to 95 on day 14, 30, 90 | 90 days |
| Activity of Daily Living Scale(ADL) score on day 14, 30, 90 | 90 days |
| Montreal Cognitive Assessment(MoCA) score on day 14, 30, 90 | 90 days |
| Serum inflammatory factors changes on day 1 and day 7 | 7 days |
| Changes in National Institute of Health stroke scale (NIHSS) on day 2,7,14 | 14 days |
| Midline shift on the CT scan | 7 days |
| Proportion of death due to any cause | 90 days |
| Proportion of Serious adverse events(SAE) | 90 days |
| Proportion of PH1 and PH2 within 48 hours after the treatment | 48 hours |
| Distribution of modified Rankin Score after the treatment | 90 days |
| Change in infarct volume | 7 days |
Countries
China
Contacts
Primary ContactJianfeng Han, MD
Backup ContactYing Tan, MD
Outcome results
None listed