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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT00200356
First received: September 12, 2005
Last updated: December 9, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Cerebral Infarction
Drug: Edaravone
Drug: Sodium Ozagrel
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Edaravone-Sodium Ozagrel (Thromboxane A2 Synthase Inhibitor) Comparative Post-Marketing Study on Acute Ischemic Stroke

Further study details as provided by Mitsubishi Tanabe Pharma Corporation:

Primary Outcome Measures:
  • the Rate of Patients With a Modified Rankin Scale Score of 0-1 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]

    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 [ Time Frame: Before treatment initiation ] [ Designated as safety issue: No ]
    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 [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 401
Study Start Date: August 2004
Study Completion Date: October 2006
Arms Assigned Interventions
Experimental: Edaravone Drug: Edaravone
Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
Other Name: Radicut
Active Comparator: Ozagrel Drug: Sodium Ozagrel
Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients can be receive drug treatment within 24 hours after stroke onset
  2. 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
  3. Patients with motor dysfunction of upper and/or lower extremities
  4. Patients aged 20 years or older when giving informed consent

Exclusion Criteria:

  1. Serum creatinine of >1.5 mg/dL
  2. Embolic infarction
  3. Intracranial haemorrhage
  4. Large infarction with severe consciousness
  5. Transient ischemic attack (TIA)
  6. A modified Rankin Scale score of ≥2 before stroke onset
  7. Patients were receive drug treatment (argatroban, urokinase, tissue plasminogen activator, heparin, warfarin sodium, aspirin, ticlopidine hydrochloride, cilostazol, edaravone and sodium ozagrel) after stroke onset
  8. Patients were receive surgical treatment or intravascular treatment
  9. With severe complications (cirrhosis, heart failure, etc.)
  10. Treating malignant tumor
  11. Pregnant or possibly pregnant women, nursing mothers
  12. History of edaravone, sodium ozagrel and ozagrel hydrochloride sensitivity
  13. Less than 3 months since any other clinical trial or postmarketing study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00200356

Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
Investigators
Study Chair: Yukito Shinohara, MD Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital
  More Information

Publications:
Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT00200356     History of Changes
Other Study ID Numbers: MCI186-13
Study First Received: September 12, 2005
Results First Received: September 13, 2012
Last Updated: December 9, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Cerebral Infarction
Infarction
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Ischemia
Necrosis
Nervous System Diseases
Pathologic Processes
Vascular Diseases
Ozagrel
Phenylmethylpyrazolone
Antioxidants
Cardiovascular Agents
Enzyme Inhibitors
Fibrin Modulating Agents
Fibrinolytic Agents
Free Radical Scavengers
Hematologic Agents
Histamine Agents
Histamine Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents

ClinicalTrials.gov processed this record on November 25, 2014