Endovascular Thrombectomy, Stroke
Conditions
Brief summary
To explore the safety and efficacy of edaravone dexborneol for the treatment of acute ischemic stroke patients who received endovascular thrombectomy.
Interventions
Intravenous injections of edaravone dexborneol (37.5mg, dissolved in 100ml saline) twice a day for 12 ±2 days.
Sponsors
Hui-Sheng Chen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. 18 to 80 years of age; 2. Patients who presented with acute ischemic stroke and a large vessel occlusion in the anterior circulation and met the criteria of mechanical thrombectomy; 3. Sufficient recanalization within 9 hours of stroke onset; 4. Sufficient recanalization （TICI 2b-3）; 5. Acute ischemic stroke with neurological baseline deficit equivalent to the National Institute of Health Stroke Scale (NIHSS) ≥ 6 before recanalization treatment; 6. First ever stroke or mRS≤1 after previous disease 7. The availability of informed consent.
Exclusion criteria
1. Acute ischemic stroke patients with insufficient recanalization（TICI \< 2a） 2. Hemorrhagic transformation (PH2) indicated by NCCT performed after the operation immediately; 3. Hemorrhagic stroke: cerebral hemorrhage, subarachnoid hemorrhage; 4. Coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia （ \<100000/mm3）; 5. 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; 6. Severe hypertension (systolic blood pressure over 200mmHg or diastolic blood pressure over 110 mmHg); 7. Patients with malignant tumor or under antineoplastic therapy with estimated lifetime less than 3 months; 8. Pregnancy, plan to get pregnant or during lactation; 9. Patients with contraindication or allergic to any ingredient of drugs in our study; 10. Unsuitable for this clinical studies assessed by researcher.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with modified Rankin Score 0 to 2 | Day 90 | Proportion of patients with modified Rankin Score 0 to 2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Distribution of modified Rankin Score | Day 90 | Distribution of modified Rankin Score after the treatment |
| Proportion of patients with modified Rankin Score 0 to 1 | Day 90 | Proportion of patients with modified Rankin Score 0 to 1 |
| Changes in National Institute of Health stroke scale (NIHSS) | 24 hours, 48 hours, and 2 weeks | the minimum and maximum values of NIHSS are 42 and 0, respectively; higher NIHSS mean a worse outcome |
| Change in infarct volume | 1 week | infarct volume is determinted by CT or DWI |
Other
| Measure | Time frame | Description |
|---|---|---|
| Proportion of death | Day 90 | death due to any cause |
| Proportion of intraparenchymal hemorrhage (PH1 and PH2) | 48 hours | Proportion of PH1 and PH2 within 48 hours after the treatment |
| Proportion of symptomatic intracranial hemorrhage (sICH) | 48 hours | sICH was defined as 4 or more increase in NIHSS caused by hemorrhage |
Countries
China
Outcome results
None listed