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

Phase 2

• Conditions: Stroke, Ischemic
• Interventions: Drug: Edaravone Dexborneol

• Registration Number: NCT04817527
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-25
• Study First Submitted QC: 2021-03-25
• Study First Posted: 2021-03-26
• Status Verified: 2021-08
• Study Start: 2021-10-01
• Last Update Submitted: 2022-03-30
• Last Update Posted: 2022-04-01
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Edaravone Dexborneol	Edaravone Dexborneol	-

Primary Outcome Measures

Name	Time	Method
Proportion of symptomatic intracranial hemorrhage (sICH)	48 hours
Proportion of patients with modified Rankin Score 0 to 3 on day 90	90 days
mTICI grade (<2 b、≥2 b) stratified for primary outcome analysis	90 days

Secondary Outcome Measures

Name	Time	Method
Changes in National Institute of Health stroke scale (NIHSS) on day 2,7,14	14 days
Change in infarct volume	7 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
The proportion of patients with Barthel Index (BI) score greater than or equal to 95 on day 14, 30, 90	90 days
Serum inflammatory factors changes on day 1 and day 7	7 days
Proportion of PH1 and PH2 within 48 hours after the treatment	48 hours
Distribution of modified Rankin Score after the treatment	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

Trial Locations

Locations (1)

First Affiliated Hospital of Xian Jiaotong University; 🇨🇳 Xi'an, Shaanxi, China