Efficacy of Edaravone with Thrombolysis in Acute Ischemic Stroke

Phase 3

Recruiting

• Conditions: Acute Ischemic Stroke.; Cerebral infarction, unspecified; I63.9

• Registration Number: IRCT20210530051440N1
• Lead Sponsor: Zanjan University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 12 July 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 244

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ational 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 Outcome Measures

Name	Time	Method
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.