Safety and Efficacy of Edaravone Dexborneol for Acute Ischemic Stroke
ConditionAcute Ischemic Stroke
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorYi Yang
About this trial
The purpose of this study is to determine the efficacy and safety of edaravone dexborneol in treating acute ischemic stroke.
Eligibility criteria
Qualifiers
Age ≥ 18 years old and ≤ 80 years old, regardless of gender;
Patients diagnosed as acute ischemic stroke according to "key points for diagnosis of all kinds of major cerebrovascular diseases in China 2019", and able to randomise and initiate edaravone dexborneol treatment less than or equal to 48 hours of stroke onset.
Total National Institute of Health stroke scale (NIHSS)≥6 and ≤24, and the sum of NIHSS score for the upper limb and the lower limb is greater than or equal to 2;
modified Rankin Scale (mRS) score of 1 or less before onset.
Disqualifiers
Reperfusion therapy (intravenous thrombolysis and endovascular therapy) has been received or planned after stroke onset.
Transient ischemic attack (TIA);
Posterior circulation stroke;
Intracranial hemorrhagic diseases seen in head imaging: hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, etc;
Trial design
Treatments tested in this trial
- Edaravone dexborneol
- Placebo
Treatment groups
1,200 Participants
are divided into 2 treatment groupsSponsors and collaborators
Yi Yang
Lead sponsor
The First Hospital of Jilin University
Sponsor institution
Source ClinicalTrials.gov