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Improving Neuroprotective Strategy for Ischemic Stroke With Sufficient Recanalization After Thrombectomy by Edaravone Dexborneol

Sponsor
Hui-Sheng Chen (Other)
Overall Status
Recruiting
CT.gov ID
NCT04667637
Collaborator
(none)
200
Enrollment
1
Location
2
Arms
15.6
Anticipated Duration (Months)
12.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To explore the safety and efficacy of edaravone dexborneol for the treatment of acute ischemic stroke patients who received endovascular thrombectomy.

Condition or Disease Intervention/Treatment Phase
  • Drug: edaravone dexborneol
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Improving Neuroprotective Strategy for Ischemic Stroke With Sufficient Recanalization After Thrombectomy by Edaravone Dexborneol (INSIST-ED): a Prospective, Randomized, Double Blinded, Multi-centre Study
Actual Study Start Date :
Feb 23, 2021
Anticipated Primary Completion Date :
Jun 14, 2022
Anticipated Study Completion Date :
Jun 14, 2022

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: 0.9% NaCl

Intravenous injections of 0.9% NaCl BID for 12 ±2days.

Drug: edaravone dexborneol
Intravenous injections of edaravone dexborneol (37.5mg, dissolved in 100ml saline) twice a day for 12 ±2 days.
Other Names:
  • edaravone deborbeol placebo

    		•
    Experimental: Edaravone Dexborneol

    Intravenous injections of edaravone dexborneol (37.5mg in 0·9% NaCl) BID for 12 ±2days.

    Drug: edaravone dexborneol
    Intravenous injections of edaravone dexborneol (37.5mg, dissolved in 100ml saline) twice a day for 12 ±2 days.
    Other Names:
  • edaravone deborbeol placebo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of patients with modified Rankin Score 0 to 2 [Day 90]

      Proportion of patients with modified Rankin Score 0 to 2

    Secondary Outcome Measures

    1. Proportion of patients with modified Rankin Score 0 to 1 [Day 90]

      Proportion of patients with modified Rankin Score 0 to 1

    2. Distribution of modified Rankin Score [Day 90]

      Distribution of modified Rankin Score after the treatment

    3. Changes in National Institute of Health stroke scale (NIHSS) [24 hours, 48 hours, and 2 weeks]

      the minimum and maximum values of NIHSS are 42 and 0, respectively; higher NIHSS mean a worse outcome

    4. Change in infarct volume [1 week]

      infarct volume is determinted by CT or DWI

    Other Outcome Measures

    1. Proportion of symptomatic intracranial hemorrhage (sICH) [48 hours]

      sICH was defined as 4 or more increase in NIHSS caused by hemorrhage

    2. Proportion of intraparenchymal hemorrhage (PH1 and PH2) [48 hours]

      Proportion of PH1 and PH2 within 48 hours after the treatment

    3. Proportion of death [Day 90]

      death due to any cause

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. 18 to 80 years of age;

    2. Patients who presented with acute ischemic stroke and a large vessel occlusion in the anterior circulation and met the criteria of mechanical thrombectomy;

    3. Sufficient recanalization within 9 hours of stroke onset;

    4. Sufficient recanalization （TICI 2b-3）;

    5. Acute ischemic stroke with neurological baseline deficit equivalent to the National Institute of Health Stroke Scale (NIHSS) ≥ 6 before recanalization treatment;

    6. First ever stroke or mRS≤1 after previous disease

    7. The availability of informed consent.

    Exclusion Criteria:

    1. Acute ischemic stroke patients with insufficient recanalization（TICI < 2a）

    2. Hemorrhagic transformation (PH2) indicated by NCCT performed after the operation immediately;

    3. Hemorrhagic stroke: cerebral hemorrhage, subarachnoid hemorrhage;

    4. Coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia （ <100000/mm3）;

    5. 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;

    6. Severe hypertension (systolic blood pressure over 200mmHg or diastolic blood pressure over 110 mmHg);

    7. Patients with malignant tumor or under antineoplastic therapy with estimated lifetime less than 3 months;

    8. Pregnancy, plan to get pregnant or during lactation;

    9. Patients with contraindication or allergic to any ingredient of drugs in our study;

    10. Unsuitable for this clinical studies assessed by researcher.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 General Hospital of Northern Theater Command ShenYang China 110840

    Sponsors and Collaborators

    • Hui-Sheng Chen

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hui-Sheng Chen, Director, General Hospital of Shenyang Military Region
    ClinicalTrials.gov Identifier:
    NCT04667637
    Other Study ID Numbers:
    • Y(2020)045
    First Posted:
    Dec 16, 2020
    Last Update Posted:
    Jan 11, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Stroke
    Ischemic Stroke
    Edaravone

    Study Results

    No Results Posted as of Jan 11, 2022