Status:
UNKNOWN
Edaravone Dexborneol for Treatment of Acute Ischemic Stroke With Endovascular Therapy in Extended Time Windows
Lead Sponsor:
First Affiliated Hospital Xi'an Jiaotong University
Conditions:
Stroke, Ischemic
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
To explore the safety and efficacy of edaravone dexborneol for patients of acute ischemic stroke received endovascular therapy in extended time windows.
Eligibility Criteria
Inclusion
- 18 to 80 years of age;
- 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);
- Patients who presented with acute ischemic stroke and a large vessel occlusion in the anterior circulation;
- Endovascular Therapy in 6-24 hours of stroke onset;
- The availability of informed consent.
Exclusion
- First ever stroke or mRS≤1 after previous disease;
- Hemorrhagic stroke: cerebral hemorrhage, subarachnoid hemorrhage;
- Coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia
- 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;
- Severe cardiac or pulmonary disease;
- Patients with malignant tumor or under antineoplastic therapy with estimated lifetime less than 3 months;
- Pregnancy, plan to get pregnant or during lactation;
- Patients with contraindication or allergic to any ingredient of drugs in our study;
- Unsuitable for this clinical studies assessed by researcher
Key Trial Info
Start Date :
October 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04817527
Start Date
October 1 2021
End Date
December 31 2022
Last Update
April 1 2022
Active Locations (1)
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1
First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, China, 710061