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Completed

NCT Number: NCT00200356

Edaravone-Sodium Ozagrel 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.

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Key information

Conditions

Cerebral Infarction Brain Diseases Brain Infarction Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Infarction Ischemia Necrosis Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Edaravone

Drug

Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.

Other names: Radicut

Sodium Ozagrel

Drug

Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Shionogi

Industry

Registry information

Official study title

Edaravone-Sodium Ozagrel (Thromboxane A2 Synthase Inhibitor) Comparative Post-Marketing Study on Acute Ischemic Stroke

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Sep 20, 2005
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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