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

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ClinicalTrials.gov Identifier: NCT00200356
Recruitment Status : Completed
First Posted : September 20, 2005
Results First Posted : January 15, 2013
Last Update Posted : January 15, 2013
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation

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.

Condition or disease Intervention/treatment Phase
Cerebral Infarction Drug: Edaravone Drug: Sodium Ozagrel Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 401 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Edaravone-Sodium Ozagrel (Thromboxane A2 Synthase Inhibitor) Comparative Post-Marketing Study on Acute Ischemic Stroke
Study Start Date : August 2004
Actual Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Edaravone

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. the Rate of Patients With a Modified Rankin Scale Score of 0-1 [ Time Frame: 3 months ]
    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 :
  1. Barthel Index Score [ Time Frame: 3 months ]

    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.


  2. Baseline NIH Stroke Scale Score [ Time Frame: Before treatment initiation ]
    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).

  3. NIH Stroke Scale Score at 14 Days [ Time Frame: 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.

  4. NIH Stroke Scale Score at 1 Month [ Time Frame: 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.

  5. NIH Stroke Scale Score at 3 Months [ Time Frame: 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.

  6. Japan Stroke Scale (Motor Function) Score at 14 Days [ Time Frame: 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.

  7. Japan Stroke Scale (Motor Function) Score at 1 Month [ Time Frame: 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.

  8. Japan Stroke Scale (Motor Function) Score at 3 Months [ Time Frame: 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.

  9. Modified Rankin Scale Score [ Time Frame: 6 months ]
    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.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications of Results:
Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT00200356     History of Changes
Other Study ID Numbers: MCI186-13
First Posted: September 20, 2005    Key Record Dates
Results First Posted: January 15, 2013
Last Update Posted: January 15, 2013
Last Verified: December 2012

Additional relevant MeSH terms:
Infarction
Cerebral Infarction
Ischemia
Pathologic Processes
Necrosis
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Stroke
Vascular Diseases
Cardiovascular Diseases
Phenylmethylpyrazolone
Antipyrine
Ozagrel
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Enzyme Inhibitors