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

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

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

Study Overview

• Status: Recruiting
• Conditions: Stroke, Ischemic
• Intervention / Treatment: Drug: Edaravone Dexborneol

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jianfeng Han, MD; Phone Number: +8618991232708; Email: rabbit1110@163.com
• Study Contact Backup: Name: Ying Tan, MD; Phone Number: +8613581693768; Email: 13581693768@163.com

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710061
      • Recruiting
      • First Affiliated Hospital of Xian Jiaotong University
      • Contact: Jianfeng Han, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: March 25, 2021
• First Submitted That Met QC Criteria: March 25, 2021
• First Posted (Actual): March 26, 2021

Study Record Updates

• Last Update Posted (Actual): April 1, 2022
• Last Update Submitted That Met QC Criteria: March 30, 2022
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Endovascular therapy; Extended Time Windows
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke; Ischemia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Neuroprotective Agents; Protective Agents; Antioxidants; Free Radical Scavengers; Edaravone
• Other Study ID Numbers: XJTU1AF2021LSK-065

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No