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

September 12, 2005
December 9, 2012
August 2004
Not Provided
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.
the rate of patients with a modified Rankin Scale score of 0-1 at 3months
Complete list of historical versions of study NCT00200356 on ClinicalTrials.gov Archive Site
  • 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.
  • 1.Barthel Index score at 3months
  • 2.NIH Stroke Scale score at 14days, 1months and 3months
  • 3.Japan Stroke Scale (Motor Function) score at 14days, 1months and 3months
  • 4.modified Rankin Scale score at 6months
Not Provided
Not Provided
 
Edaravone-Sodium Ozagrel Comparative Post-Marketing Study on Acute Ischemic Stroke
Edaravone-Sodium Ozagrel (Thromboxane A2 Synthase Inhibitor) Comparative Post-Marketing Study on Acute Ischemic Stroke

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Cerebral Infarction
  • 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
  • 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.
  • Experimental: Edaravone
    Intervention: Drug: Edaravone
  • Active Comparator: Ozagrel
    Intervention: Drug: Sodium Ozagrel
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. Epub 2009 Mar 26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
401
October 2006
Not Provided

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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00200356
MCI186-13
No
Mitsubishi Tanabe Pharma Corporation
Mitsubishi Tanabe Pharma Corporation
Not Provided
Study Chair: Yukito Shinohara, MD Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital
Mitsubishi Tanabe Pharma Corporation
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP