Acute Ischemic Stroke
Conditions
Sponsors
SHIONOGI & CO., LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Main Inclusion Criteria - Patients diagnosed with supratentorial ischemic stroke on magnetic resonance imaging (MRI) - Patients who can be enrolled within 24 hours from 4.5 hours after the onset of ischemic stroke - Patients with neurologic signs corresponding to 8-22 on the National Institute of Health Stroke Scale (NIHSS) score and who have not experienced a rapid change in neurologic signs within 30 minutes before enrollment etc
Exclusion criteria
Exclusion criteria: Main Exclusion Criteria - Patients with a disability corresponding to mRS score of >=2 before the onset of ischemic stroke - Patients who have undergone thrombolysis or intravascular recanalization therapy within 90 days before obtaining informed consent. - Patients with a history of stroke or intracranial hemorrhage that caused neurological events within 90 days before obtaining informed consent. - Patients diagnosed with a transient ischemic attack - Patients who cannot have MRI etc
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy mRS 90 days after the first dose | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy Main Secondary Outcome Safety - Adverse events, vital signs (blood pressure, pulse rate, body temperature, respiratory rate), electrocardiogram, clinical laboratory tests Efficacy - mRS at each visit other than day 90 - Proportion of subjects with mRS of <=1, <=2, and 5 or 6 at each visit etc | — |
Countries
Japan
Outcome results
None listed