Cerebral infarction
Conditions
Interventions
None listed
Sponsors
Mitsubishi Tanabe Pharma Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients receiving the first dose of edaravone within 4.5 hours after onset 2.Level of consciousness 0 to II-30 (Japan coma scale) 3.Motor weakness of upper/lower extremities
Exclusion criteria
Exclusion criteria: 1.Patients whose serum creatinine was over 1.5 mg/dL at baseline 2.Patients with history of hypersensitivity to any component of edaravone 3.Patients judged as ineligible by the investigator because of poor general condition caused by severe liver disease (ex., cirrhosis) or cardiac disease (ex., cardiac failure) which requires treatment in hospital, or by infection which requires antibiotics treatment 4.Patients with mRS score ≥2 before onset 5.Patients with severe neuropathy (NIHSS score ≥23) before edaravone treatment 6.Patients with recurrent cerebral infarction(CI) who experienced previous CI within 3 months 7.Patients with CI associated with intracranial hemorrhage 8.Patients considered to be at higher risk for transient ischemic attack (TIA) by a doctor because his/her neurological signs improved rapidly 9.Patients judged as ineligible for other reasons by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)mRS score 3 months after onset (76-104 days) (Score 0 or 1 is defined as favorable clinical outcome) 2)sICH within 36 hours after the first dose of edaravone | — |
Countries
Japan
Contacts
Public ContactIshizaki Kaoru
Mitsubishi Tanabe Pharma Corporation Pharmacovigilance Department
Outcome results
None listed