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Edaravone-Sodium Ozagrel Comparative Post-Marketing Study on Acute Ischemic Stroke

Primary Purpose

Cerebral Infarction

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Edaravone
Sodium Ozagrel
Sponsored by
Mitsubishi Tanabe Pharma Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Infarction

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients can be receive drug treatment within 24 hours after stroke onset Patients with a level of consciousness between 0 (alert) and 3 (unable to recall name and date of birth) according to the Japan Coma Scale Patients with motor dysfunction of upper and/or lower extremities Patients aged 20 years or older when giving informed consent Exclusion Criteria: Serum creatinine of >1.5 mg/dL Embolic infarction Intracranial haemorrhage Large infarction with severe consciousness Transient ischemic attack (TIA) A modified Rankin Scale score of ≥2 before stroke onset Patients were receive drug treatment (argatroban, urokinase, tissue plasminogen activator, heparin, warfarin sodium, aspirin, ticlopidine hydrochloride, cilostazol, edaravone and sodium ozagrel) after stroke onset Patients were receive surgical treatment or intravascular treatment With severe complications (cirrhosis, heart failure, etc.) Treating malignant tumor Pregnant or possibly pregnant women, nursing mothers History of edaravone, sodium ozagrel and ozagrel hydrochloride sensitivity Less than 3 months since any other clinical trial or postmarketing study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Edaravone

    Ozagrel

    Arm Description

    Outcomes

    Primary Outcome Measures

    the Rate of Patients With a Modified Rankin Scale Score of 0-1
    The number of patients with mRS score of 0-1 (good outcome) at 3 months after treatment initiation. The mRS has 6 items, where 0 = No symptoms at all, 1 = No significant disability despite symptoms, 2 = Slight disability, 3 = Moderate disability, 4 = Moderately severe disability, 5 = Severe disability. The higher scores reflect increased disability.

    Secondary Outcome Measures

    Barthel Index Score
    The Barthel Index of Activities of Daily Living measures functional disability by quantifying patient performance in 10 activities of daily life. These activities can be grouped according to self-care (feeding, grooming, bathing, dressing, bowel and bladder care, and toilet use) and mobility (ambulation, transfers, and stair climbing). 5-point increments are used in scoring, with a maximal score of 100 indicating that a patient is fully independent in physical functioning, and a lowest score of 0 representing a totally dependent bed-ridden state. The number of patients with 95-100 Barthel Index was evaluated at at 3 months after treatment initiation.
    Baseline NIH Stroke Scale Score
    The NIH stroke scale is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42(dead).
    NIH Stroke Scale Score at 14 Days
    The NIH stroke scale is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42(dead). The number of patients with NIH stroke scale score of 0-1 at 14 days after treatment initiation.
    NIH Stroke Scale Score at 1 Month
    The NIH stroke scale is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42(dead). The number of patients with NIH stroke scale score of 0-1 at 1 month after treatment initiation.
    NIH Stroke Scale Score at 3 Months
    The NIH stroke scale is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42(dead). The number of patients with NIH stroke scale score of 0-1 at 3 months after treatment initiation.
    Japan Stroke Scale (Motor Function) Score at 14 Days
    The Japan stroke scale (motor function) is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from -0.26 (no deficit) to 31.29 (worst). The mean of Japan stroke scale (motor function) score at 14 days after treatment initiation.
    Japan Stroke Scale (Motor Function) Score at 1 Month
    The Japan stroke scale (motor function) is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from -0.26 (no deficit) to 31.29 (worst). The mean of Japan stroke scale (motor function) score at 1 month after treatment initiation.
    Japan Stroke Scale (Motor Function) Score at 3 Months
    The Japan stroke scale (motor function) is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from -0.26 (no deficit) to 31.29 (worst). The mean of Japan stroke scale (motor function) score at 3 months after treatment initiation.
    Modified Rankin Scale Score
    The number of patients with an Modified Rankin Scale score of 0-1 was evaluated at 6 months after treatment initiation. The Modified Rankin Scale has 6 items, where 0 = No symptoms at all, 1 = No significant disability despite symptoms, 2 = Slight disability, 3 = Moderate disability, 4 = Moderately severe disability, 5 = Severe disability. The higher scores reflect increased disability.

    Full Information

    First Posted
    September 12, 2005
    Last Updated
    December 9, 2012
    Sponsor
    Mitsubishi Tanabe Pharma Corporation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00200356
    Brief Title
    Edaravone-Sodium Ozagrel Comparative Post-Marketing Study on Acute Ischemic Stroke
    Official Title
    Edaravone-Sodium Ozagrel (Thromboxane A2 Synthase Inhibitor) Comparative Post-Marketing Study on Acute Ischemic Stroke
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2004 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    October 2006 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Mitsubishi Tanabe Pharma Corporation

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study is randomized, Sodium Ozagrel (Thromboxane A2 Synthase Inhibitor) controlled study on acute ischemic stroke. The primary endpoints were the rate of patients with modified Rankin Scale score of 0-1 at 3 months.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cerebral Infarction

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    401 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Edaravone
    Arm Type
    Experimental
    Arm Title
    Ozagrel
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Edaravone
    Other Intervention Name(s)
    Radicut
    Intervention Description
    Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
    Intervention Type
    Drug
    Intervention Name(s)
    Sodium Ozagrel
    Intervention Description
    Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
    Primary Outcome Measure Information:
    Title
    the Rate of Patients With a Modified Rankin Scale Score of 0-1
    Description
    The number of patients with mRS score of 0-1 (good outcome) at 3 months after treatment initiation. The mRS has 6 items, where 0 = No symptoms at all, 1 = No significant disability despite symptoms, 2 = Slight disability, 3 = Moderate disability, 4 = Moderately severe disability, 5 = Severe disability. The higher scores reflect increased disability.
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Barthel Index Score
    Description
    The Barthel Index of Activities of Daily Living measures functional disability by quantifying patient performance in 10 activities of daily life. These activities can be grouped according to self-care (feeding, grooming, bathing, dressing, bowel and bladder care, and toilet use) and mobility (ambulation, transfers, and stair climbing). 5-point increments are used in scoring, with a maximal score of 100 indicating that a patient is fully independent in physical functioning, and a lowest score of 0 representing a totally dependent bed-ridden state. The number of patients with 95-100 Barthel Index was evaluated at at 3 months after treatment initiation.
    Time Frame
    3 months
    Title
    Baseline NIH Stroke Scale Score
    Description
    The NIH stroke scale is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42(dead).
    Time Frame
    Before treatment initiation
    Title
    NIH Stroke Scale Score at 14 Days
    Description
    The NIH stroke scale is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42(dead). The number of patients with NIH stroke scale score of 0-1 at 14 days after treatment initiation.
    Time Frame
    14 days
    Title
    NIH Stroke Scale Score at 1 Month
    Description
    The NIH stroke scale is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42(dead). The number of patients with NIH stroke scale score of 0-1 at 1 month after treatment initiation.
    Time Frame
    1 month
    Title
    NIH Stroke Scale Score at 3 Months
    Description
    The NIH stroke scale is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42(dead). The number of patients with NIH stroke scale score of 0-1 at 3 months after treatment initiation.
    Time Frame
    3 months
    Title
    Japan Stroke Scale (Motor Function) Score at 14 Days
    Description
    The Japan stroke scale (motor function) is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from -0.26 (no deficit) to 31.29 (worst). The mean of Japan stroke scale (motor function) score at 14 days after treatment initiation.
    Time Frame
    14 days
    Title
    Japan Stroke Scale (Motor Function) Score at 1 Month
    Description
    The Japan stroke scale (motor function) is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from -0.26 (no deficit) to 31.29 (worst). The mean of Japan stroke scale (motor function) score at 1 month after treatment initiation.
    Time Frame
    1 month
    Title
    Japan Stroke Scale (Motor Function) Score at 3 Months
    Description
    The Japan stroke scale (motor function) is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from -0.26 (no deficit) to 31.29 (worst). The mean of Japan stroke scale (motor function) score at 3 months after treatment initiation.
    Time Frame
    3 months
    Title
    Modified Rankin Scale Score
    Description
    The number of patients with an Modified Rankin Scale score of 0-1 was evaluated at 6 months after treatment initiation. The Modified Rankin Scale has 6 items, where 0 = No symptoms at all, 1 = No significant disability despite symptoms, 2 = Slight disability, 3 = Moderate disability, 4 = Moderately severe disability, 5 = Severe disability. The higher scores reflect increased disability.
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients can be receive drug treatment within 24 hours after stroke onset Patients with a level of consciousness between 0 (alert) and 3 (unable to recall name and date of birth) according to the Japan Coma Scale Patients with motor dysfunction of upper and/or lower extremities Patients aged 20 years or older when giving informed consent Exclusion Criteria: Serum creatinine of >1.5 mg/dL Embolic infarction Intracranial haemorrhage Large infarction with severe consciousness Transient ischemic attack (TIA) A modified Rankin Scale score of ≥2 before stroke onset Patients were receive drug treatment (argatroban, urokinase, tissue plasminogen activator, heparin, warfarin sodium, aspirin, ticlopidine hydrochloride, cilostazol, edaravone and sodium ozagrel) after stroke onset Patients were receive surgical treatment or intravascular treatment With severe complications (cirrhosis, heart failure, etc.) Treating malignant tumor Pregnant or possibly pregnant women, nursing mothers History of edaravone, sodium ozagrel and ozagrel hydrochloride sensitivity Less than 3 months since any other clinical trial or postmarketing study
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yukito Shinohara, MD
    Organizational Affiliation
    Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19321945
    Citation
    Shinohara Y, Saito I, Kobayashi S, Uchiyama S. Edaravone (radical scavenger) versus sodium ozagrel (antiplatelet agent) in acute noncardioembolic ischemic stroke (EDO trial). Cerebrovasc Dis. 2009;27(5):485-92. doi: 10.1159/000210190. Epub 2009 Mar 26.
    Results Reference
    result

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    Edaravone-Sodium Ozagrel Comparative Post-Marketing Study on Acute Ischemic Stroke

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