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Thrombolysis Combined With Edaravone Dexborneol on Hemorrhagic Transformation for Acute Ischemic Stroke

Primary Purpose

Stroke, Ischemic

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Edaravone Dexborneol
Placebo
Sponsored by
Huashan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Ischemic

Eligibility Criteria

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

Inclusion Criteria:

  • Acute ischemic stroke;
  • 18 to 80 years of age;
  • There are clear signs of neurological deficit: 8≤NIHSS score≤24;
  • Received alteplase thrombolysis therapy within 4.5 hours after onset;
  • Patients signed written inform consent

Exclusion Criteria:

  • Patients need endovascular therapy or bridge therapy;
  • Cranial CT scan finds intracranial bleeding disorders: hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage;
  • Severe head trauma or stroke, intracranial tumor or large intracranial aneurysm within 3 months;
  • Intracranial or intraspinal surgery within 3 months;
  • Active visceral hemorrhage
  • Major surgery within 2 weeks or arterial puncture within 1 week that is difficult to compress the hemostatic site;
  • Unknown onset time;
  • Rapid improvement of symptoms or mild symptoms before thrombolysis therapy;
  • A platelet count below 100,000/mm3 indicates a propensity for acute bleeding;
  • Therapeutic neuroprotective agents have been applied after onset of stroke, including commercially available edaravone, nimodipine, ganglioside, citicoline, piracetam, butyl benzene peptides, Urinary Kallidinogenase;
  • Patients with severe mental disorders and dementia;
  • ALT or AST is greater than 2.0×ULN or previously known liver diseases, such as acute hepatitis, chronic active hepatitis, liver cirrhosis;
  • Serum Creatinine (SCr) is greater than 1.5×ULN, Creatinine Clearance (CrCl) is less than 50 ml/min or previously known severe renal diseases;
  • Patients with malignant tumors or severe systemic disease;
  • allergic to edaravone , (+)-Borneol or related excipients;
  • Pregnant or lactating women;
  • Have major surgery within 4 weeks before enrollment;
  • Participated in other clinical studies within 30 days before randomization; or participating in other clinical trials at present;
  • The investigators consider the patients are not suitable for this trial.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Edaravone

    Placebo

    Arm Description

    Edaravone Dexborneol injection

    Edaravone Dexborneol matching injection

    Outcomes

    Primary Outcome Measures

    The proportion of symptomatic intracranial hemorrhage

    Secondary Outcome Measures

    The proportion of symptomatic intracranial hemorrhage
    The proportion of intracranial hemorrhage
    The proportion of Participants With modified Rankin Scale (mRS) Score 0 to 1
    The change in the NIH stroke scale (NIHSS) from the baseline
    The proportion of Participants With Barthel Index (BI) score greater than or equal to 95
    Vascular recanalization
    Blood Brain Barrier Permeability
    Proportion of Encephaledema
    Proportion of Death

    Full Information

    First Posted
    September 3, 2021
    Last Updated
    September 3, 2021
    Sponsor
    Huashan Hospital
    Collaborators
    Shanghai Stroke Association
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05035953
    Brief Title
    Thrombolysis Combined With Edaravone Dexborneol on Hemorrhagic Transformation for Acute Ischemic Stroke
    Official Title
    Effect of Thrombolysis Combined With Edaravone Dexborneol for Acute Ischemic Stroke Patients: a Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 13, 2021 (Anticipated)
    Primary Completion Date
    September 13, 2023 (Anticipated)
    Study Completion Date
    March 13, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Huashan Hospital
    Collaborators
    Shanghai Stroke Association

    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 the treatment of acute ischemic stroke patients who received thrombolysis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke, Ischemic

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Edaravone
    Arm Type
    Experimental
    Arm Description
    Edaravone Dexborneol injection
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Edaravone Dexborneol matching injection
    Intervention Type
    Drug
    Intervention Name(s)
    Edaravone Dexborneol
    Intervention Description
    Edaravone Dexborneol 37.5 mg (containing Edaravone 30 mg and Dexborneol 7.5 mg), BID, 14 days, addition to thrombolysis
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Edaravone Dexborneol matching injection, addition to thrombolysis
    Primary Outcome Measure Information:
    Title
    The proportion of symptomatic intracranial hemorrhage
    Time Frame
    36-48 hours
    Secondary Outcome Measure Information:
    Title
    The proportion of symptomatic intracranial hemorrhage
    Time Frame
    7 days
    Title
    The proportion of intracranial hemorrhage
    Time Frame
    36-48 hours, 7 days
    Title
    The proportion of Participants With modified Rankin Scale (mRS) Score 0 to 1
    Time Frame
    90 days
    Title
    The change in the NIH stroke scale (NIHSS) from the baseline
    Time Frame
    36-48 hours, 7, 14 and 90 days
    Title
    The proportion of Participants With Barthel Index (BI) score greater than or equal to 95
    Time Frame
    14 and 90 days
    Title
    Vascular recanalization
    Time Frame
    36-48 hours
    Title
    Blood Brain Barrier Permeability
    Time Frame
    36-48 hours
    Title
    Proportion of Encephaledema
    Time Frame
    36-48 hours
    Title
    Proportion of Death
    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: Acute ischemic stroke; 18 to 80 years of age; There are clear signs of neurological deficit: 8≤NIHSS score≤24; Received alteplase thrombolysis therapy within 4.5 hours after onset; Patients signed written inform consent Exclusion Criteria: Patients need endovascular therapy or bridge therapy; Cranial CT scan finds intracranial bleeding disorders: hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage; Severe head trauma or stroke, intracranial tumor or large intracranial aneurysm within 3 months; Intracranial or intraspinal surgery within 3 months; Active visceral hemorrhage Major surgery within 2 weeks or arterial puncture within 1 week that is difficult to compress the hemostatic site; Unknown onset time; Rapid improvement of symptoms or mild symptoms before thrombolysis therapy; A platelet count below 100,000/mm3 indicates a propensity for acute bleeding; Therapeutic neuroprotective agents have been applied after onset of stroke, including commercially available edaravone, nimodipine, ganglioside, citicoline, piracetam, butyl benzene peptides, Urinary Kallidinogenase; Patients with severe mental disorders and dementia; ALT or AST is greater than 2.0×ULN or previously known liver diseases, such as acute hepatitis, chronic active hepatitis, liver cirrhosis; Serum Creatinine (SCr) is greater than 1.5×ULN, Creatinine Clearance (CrCl) is less than 50 ml/min or previously known severe renal diseases; Patients with malignant tumors or severe systemic disease; allergic to edaravone , (+)-Borneol or related excipients; Pregnant or lactating women; Have major surgery within 4 weeks before enrollment; Participated in other clinical studies within 30 days before randomization; or participating in other clinical trials at present; The investigators consider the patients are not suitable for this trial.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Qiang Dong
    Phone
    86-21-52887142
    Email
    qiang_dong163@163.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Thrombolysis Combined With Edaravone Dexborneol on Hemorrhagic Transformation for Acute Ischemic Stroke

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