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

Sponsor

First Affiliated Hospital Xi'an Jiaotong University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04817527

Collaborator

(none)

200

Enrollment

Location

Arms

Anticipated Duration (Months)

13.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Stroke, Ischemic	Drug: Edaravone Dexborneol	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Edaravone Dexborneol for Treatment of Acute Ischemic Stroke With Endovascular Therapy in Extended Time Windows (EXISTENT):a Prospective, Randomized, Open-label, Multi-centre Study

Actual Study Start Date :

Oct 1, 2021

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Edaravone Dexborneol	Drug: Edaravone Dexborneol Intravenous injections of edaravone dexborneol (37.5mg in 0·9% NaCl) BID for 7-14days.
No Intervention: conventional therapy conventional therapy of acute ischemic stroke after Endovascular Therapy based on Chinese guidelines for endovascular therapy

Arm

Intervention/Treatment

Experimental: Edaravone Dexborneol

Drug: Edaravone Dexborneol

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

No Intervention: conventional therapy

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Changes in National Institute of Health stroke scale (NIHSS) on day 2,7,14 [14 days]
Distribution of modified Rankin Score after the treatment [90 days]
Change in infarct volume [7 days]
The proportion of patients with Barthel Index (BI) score greater than or equal to 95 on day 14, 30, 90 [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]
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]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 Criteria:

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