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

NCT ID: NCT04817527

Last Updated: 2022-04-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2022-12-31

Brief Summary

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

Conditions

Stroke, Ischemic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Edaravone Dexborneol

Group Type: EXPERIMENTAL

Edaravone Dexborneol

Intervention Type: DRUG

Intravenous injections of edaravone dexborneol (37.5mg in 0·9% NaCl) BID for 7-14days.

conventional therapy

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Edaravone Dexborneol

Intravenous injections of edaravone dexborneol (37.5mg in 0·9% NaCl) BID for 7-14days.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

First Affiliated Hospital of Xian Jiaotong University

Xi'an, Shaanxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jianfeng Han, MD

Role: CONTACT

rabbit1110@163.com

+8618991232708

Ying Tan, MD

Role: CONTACT

13581693768@163.com

+8613581693768

Facility Contacts

Jianfeng Han, MD

Role: primary

Other Identifiers

XJTU1AF2021LSK-065

Identifier Type: -

Identifier Source: org_study_id