Edaravone Dexborneol for Treatment of Acute Ischemic Stroke With Endovascular Therapy in Extended Time Windows (EXISTENT)

Xi'an Jiaotong University

Status and phase: Unknown; Phase 2

Conditions: Stroke, Ischemic

Treatments: Drug: Edaravone Dexborneol

Study type: Interventional

Funder types: Other

Identifiers

NCT04817527

XJTU1AF2021LSK-065

Details and patient eligibility

About

To explore the safety and efficacy of edaravone dexborneol for patients of acute ischemic stroke received endovascular therapy in extended time windows.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Edaravone Dexborneol

Experimental group

Treatment:

Drug: Edaravone Dexborneol

conventional therapy

No Intervention group

Description:

conventional therapy of acute ischemic stroke after Endovascular Therapy based on Chinese guidelines for endovascular therapy