Post-marketing Registry On Treatment with Edaravone in acute Cerebral infarction by the Time window of 4.5 hours
- Conditions
- Cerebral infarction
- Registration Number
- JPRN-UMIN000009227
- Lead Sponsor
- Mitsubishi Tanabe Pharma Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 10000
Not provided
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method