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

Primary Purpose

Stroke, Ischemic

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Edaravone Dexborneol
Sponsored by
First Affiliated Hospital Xi'an Jiaotong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Ischemic focused on measuring Endovascular therapy, Extended Time Windows

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • First Affiliated Hospital of Xian Jiaotong UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Edaravone Dexborneol

conventional therapy

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Changes in National Institute of Health stroke scale (NIHSS) on day 2,7,14
Distribution of modified Rankin Score after the treatment
Change in infarct volume
The proportion of patients with Barthel Index (BI) score greater than or equal to 95 on day 14, 30, 90
Activity of Daily Living Scale(ADL) score on day 14, 30, 90
Montreal Cognitive Assessment(MoCA) score on day 14, 30, 90
Serum inflammatory factors changes on day 1 and day 7
Proportion of PH1 and PH2 within 48 hours after the treatment
Midline shift on the CT scan
Proportion of death due to any cause
Proportion of Serious adverse events(SAE)

Full Information

First Posted
March 25, 2021
Last Updated
March 30, 2022
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
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1. Study Identification

Unique Protocol Identification Number
NCT04817527
Brief Title
Edaravone Dexborneol for Treatment of Acute Ischemic Stroke With Endovascular Therapy in Extended Time Windows
Acronym
EXISTENT
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital Xi'an Jiaotong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Ischemic
Keywords
Endovascular therapy, Extended Time Windows

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Edaravone Dexborneol
Arm Type
Experimental
Arm Title
conventional therapy
Arm Type
No Intervention
Arm Description
conventional therapy of acute ischemic stroke after Endovascular Therapy based on Chinese guidelines for endovascular therapy
Intervention Type
Drug
Intervention Name(s)
Edaravone Dexborneol
Intervention Description
Intravenous injections of edaravone dexborneol (37.5mg in 0·9% NaCl) BID for 7-14days.
Primary Outcome Measure Information:
Title
Proportion of patients with modified Rankin Score 0 to 3 on day 90
Time Frame
90 days
Title
Proportion of symptomatic intracranial hemorrhage (sICH)
Time Frame
48 hours
Title
mTICI grade (<2 b、≥2 b) stratified for primary outcome analysis
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Changes in National Institute of Health stroke scale (NIHSS) on day 2,7,14
Time Frame
14 days
Title
Distribution of modified Rankin Score after the treatment
Time Frame
90 days
Title
Change in infarct volume
Time Frame
7 days
Title
The proportion of patients with Barthel Index (BI) score greater than or equal to 95 on day 14, 30, 90
Time Frame
90 days
Title
Activity of Daily Living Scale(ADL) score on day 14, 30, 90
Time Frame
90 days
Title
Montreal Cognitive Assessment(MoCA) score on day 14, 30, 90
Time Frame
90 days
Title
Serum inflammatory factors changes on day 1 and day 7
Time Frame
7 days
Title
Proportion of PH1 and PH2 within 48 hours after the treatment
Time Frame
48 hours
Title
Midline shift on the CT scan
Time Frame
7 days
Title
Proportion of death due to any cause
Time Frame
90 days
Title
Proportion of Serious adverse events(SAE)
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianfeng Han, MD
Phone
+8618991232708
Email
rabbit1110@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ying Tan, MD
Phone
+8613581693768
Email
13581693768@163.com
Facility Information:
Facility Name
First Affiliated Hospital of Xian Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianfeng Han, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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