Edaravone-Sodium Ozagrel Comparative Post-Marketing Study on Acute Ischemic Stroke
- Registration Number
- NCT00200356
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 401
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Edaravone Edaravone - Ozagrel Sodium Ozagrel -
- Primary Outcome Measures
Name Time Method the Rate of Patients With a Modified Rankin Scale Score of 0-1 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
Name Time Method Barthel Index Score 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.Baseline NIH Stroke Scale Score 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).
NIH Stroke Scale Score at 14 Days 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 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 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 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 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 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 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.