Acute Ischemic Stroke. Cerebral infarction, unspecified
Conditions
Interventions
Intervention 1: Intervention group: Case group consists of patients receiving Alteplase within 4.5 hours of onset of manifestations and dose of 0.6 to 0.9 mg/kg in combination with Edaravone within 1
Sponsors
Zanjan University of Medical Sciences
Zistdaru Danesh company
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Diagnosis AIS as acute onset of neurological symptoms, confirming by neuroimaging examination of the head – computed tomography (CT) or magnetic resonance imaging (MRI) Patients included receiving r-TPA Age 18-75 years NIHSS between 4 and 24with a total score of upper and lower limbs = 2 on motor deficits Patients receiving Edaravone within 1 to 24 hour of admission
Exclusion criteria
Exclusion criteria: Cranial CT scan finds intracranial bleeding disorders Vasculitis Arterial dissection, Despite initial controlling of blood pressure (BP); systolic BP still greater than or equal to 220 mmHg, or diastolic BP greater than or equal to 120 mmHg Iatrogenic stroke Patients with severe mental disorders and dementia Significant lung disease (FEV1 =1.5 L, pO2 =70 on room air, pCO2 =45) Psychiatric illness requiring medication Prior consumption of therapeutic neuroprotective agents, including commercially available Edaravone, Nimodipine, Ganglioside, Citicoline or Piracetam Patients with malignant tumors or receiving concurrent antitumor treatment Patients with severe systemic disease or life expectancy less than 90 days Pregnant or lactating women History of hypersensitivity to Edaravone or any of the inactive ingredients, including sulfite hypersensitivity MRS = 2 prior to stroke NIHSS = 25 or = 3 in admission Severe disturbance of consciousness: NIHSS category 1a for consciousness = 2 History of AIS within 3 months Severe heart disease (Ejection Fraction less than 30%) Baseline Creatinine clearance less than 30 ml/min, creatinine 150 mol/L or previously known severe renal diseases ALT or AST is greater than 2.0×ULN or previously known liver diseases, such as acute hepatitis, chronic active hepatitis or liver cirrhosis Infections requiring antibiotic administration Manifesting considerable improvement in neurologic signs and symptoms indicating transient ischemic attack
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| National Institutes of Health Stroke Scale (NIHSS) score. Timepoint: At Admission, 24 hours later and at discharge. Method of measurement: Physical Examination.;Modified Rankin Scale (MRS) score. Timepoint: (Pre-stroke) At admission and 3 months after discharge. Method of measurement: Questionnaire.;Mortality. Timepoint: In-hospital and during 3 months after discharge. Method of measurement: Medical records and follow up information. | — |
Secondary
| Measure | Time frame |
|---|---|
| Symptomatic Intracranial Hemorrhage. Timepoint: During hospitalization. Method of measurement: Physical Examination and Imaging.;Acute Hepatic Failure. Timepoint: During hospitalization. Method of measurement: Paraclinic assessment.;Acute Renal Failure. Timepoint: During hospitalization. Method of measurement: Paraclinic assessment.;Mechanical ventilation rate. Timepoint: Within 2 days of hospitalization. Method of measurement: Clinical assessment.;Infarction Volume. Timepoint: On third day MRI (Magnetic Resonance Imaging). Method of measurement: Paraclinic assessment.;Brain midline shift. Timepoint: On third day MRI (Magnetic Resonance Imaging). Method of measurement: Paraclinic assessment.;Alberta stroke program early CT score (ASPECTS). Timepoint: At admission and at discharge. Method of measurement: Paraclinic assessment. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactShahin Nateghi
Zanjan University of Medical Sciences
Outcome results
None listed