Cerebral Infarction
Conditions
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.
Interventions
DRUGEdaravone
Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
DRUGSodium Ozagrel
Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
Sponsors
Tanabe Pharma Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Edaravone Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening. | 191 |
| Ozagrel Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening. | 195 |
| Total | 386 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lack of Efficacy | 3 | 3 |
| Overall Study | Nontreatment | 1 | 0 |
| Overall Study | Protocol Violation | 4 | 4 |
Baseline characteristics
| Characteristic | Edaravone | Ozagrel | Total |
|---|---|---|---|
| Age, Customized 20-64 years | 64 years | 58 years | 122 years |
| Age, Customized 65- years | 127 years | 137 years | 264 years |
| Age, Customized birth-19 years | 0 years | 0 years | 0 years |
| Sex: Female, Male Female | 70 Participants | 77 Participants | 147 Participants |
| Sex: Female, Male Male | 121 Participants | 118 Participants | 239 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 102 / 194 | 107 / 198 |
| serious Total, serious adverse events | 27 / 194 | 28 / 198 |
Outcome results
Primary
the Rate of Patients With a Modified Rankin Scale Score of 0-1
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.
Time frame: 3 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Edaravone | the Rate of Patients With a Modified Rankin Scale Score of 0-1 | Score(0-1) | 109 participants |
| Edaravone | the Rate of Patients With a Modified Rankin Scale Score of 0-1 | 0 | 46 participants |
| Edaravone | the Rate of Patients With a Modified Rankin Scale Score of 0-1 | 1 | 63 participants |
| Edaravone | the Rate of Patients With a Modified Rankin Scale Score of 0-1 | 2 | 37 participants |
| Edaravone | the Rate of Patients With a Modified Rankin Scale Score of 0-1 | 3 | 22 participants |
| Edaravone | the Rate of Patients With a Modified Rankin Scale Score of 0-1 | 4 | 19 participants |
| Edaravone | the Rate of Patients With a Modified Rankin Scale Score of 0-1 | 5 | 2 participants |
| Edaravone | the Rate of Patients With a Modified Rankin Scale Score of 0-1 | Death | 2 participants |
| Ozagrel | the Rate of Patients With a Modified Rankin Scale Score of 0-1 | Death | 1 participants |
| Ozagrel | the Rate of Patients With a Modified Rankin Scale Score of 0-1 | Score(0-1) | 98 participants |
| Ozagrel | the Rate of Patients With a Modified Rankin Scale Score of 0-1 | 3 | 29 participants |
| Ozagrel | the Rate of Patients With a Modified Rankin Scale Score of 0-1 | 0 | 39 participants |
| Ozagrel | the Rate of Patients With a Modified Rankin Scale Score of 0-1 | 5 | 3 participants |
| Ozagrel | the Rate of Patients With a Modified Rankin Scale Score of 0-1 | 1 | 59 participants |
| Ozagrel | the Rate of Patients With a Modified Rankin Scale Score of 0-1 | 4 | 24 participants |
| Ozagrel | the Rate of Patients With a Modified Rankin Scale Score of 0-1 | 2 | 40 participants |
Secondary
Barthel Index Score
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.
Time frame: 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Edaravone | Barthel Index Score | 148 participants |
| Ozagrel | Barthel Index Score | 133 participants |
Secondary
Baseline NIH Stroke Scale Score
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).
Time frame: Before treatment initiation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Edaravone | Baseline NIH Stroke Scale Score | 3.7 scores on a scale | Standard Deviation 2.3 |
| Ozagrel | Baseline NIH Stroke Scale Score | 3.8 scores on a scale | Standard Deviation 2.7 |
Secondary
Japan Stroke Scale (Motor Function) Score at 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.
Time frame: 14 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Edaravone | Japan Stroke Scale (Motor Function) Score at 14 Days | 4.521 units on a scale | Standard Deviation 6.651 |
| Ozagrel | Japan Stroke Scale (Motor Function) Score at 14 Days | 4.686 units on a scale | Standard Deviation 6.872 |
Secondary
Japan Stroke Scale (Motor Function) Score at 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.
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Edaravone | Japan Stroke Scale (Motor Function) Score at 1 Month | 3.632 units on a scale | Standard Deviation 6.086 |
| Ozagrel | Japan Stroke Scale (Motor Function) Score at 1 Month | 3.680 units on a scale | Standard Deviation 5.885 |
Secondary
Japan Stroke Scale (Motor Function) Score at 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.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Edaravone | Japan Stroke Scale (Motor Function) Score at 3 Months | 2.507 units on a scale | Standard Deviation 5.232 |
| Ozagrel | Japan Stroke Scale (Motor Function) Score at 3 Months | 2.927 units on a scale | Standard Deviation 5.361 |
Secondary
Modified Rankin Scale Score
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.
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Edaravone | Modified Rankin Scale Score | 112 participants |
| Ozagrel | Modified Rankin Scale Score | 108 participants |
Secondary
NIH Stroke Scale Score at 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.
Time frame: 14 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Edaravone | NIH Stroke Scale Score at 14 Days | 98 participants |
| Ozagrel | NIH Stroke Scale Score at 14 Days | 108 participants |
Secondary
NIH Stroke Scale Score at 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.
Time frame: 1 month
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Edaravone | NIH Stroke Scale Score at 1 Month | 117 participants |
| Ozagrel | NIH Stroke Scale Score at 1 Month | 119 participants |
Secondary
NIH Stroke Scale Score at 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.
Time frame: 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Edaravone | NIH Stroke Scale Score at 3 Months | 135 participants |
| Ozagrel | NIH Stroke Scale Score at 3 Months | 140 participants |