This clinical study is designed to evaluate the efficacy and safety of the combination therapy of SP-8203 (otaplimastat) and thrombolytic standard of care in acute ischemic stroke patient.
As a standard of care, thrombolytic therapy (for instance, recombinant tissue plasminogen activator) will be administered. When reperfusion is not achieved in spite of thrombolytic therapy, endovascular therapy can be performed.
Patients with neurologic deficit of ≥ 8 points by National Institute of Health Stroke Scale (NIHSS) score
Patients with pre-stroke modified Rankin Scale (mRS) must be 0 or 1, which means they were able to carry out all usual duties and activities
Adults aged ≥19 years and ≤85 years
Patients who can receive thrombolytic standard of care within 4.5 hours after the onset of early symptoms of acute ischemic stroke
Patients with systemic allergic diseases or hypersensitivity to specific drugs.
Patients who were diagnosed with myocardial infarction (MI) within the last 6 months.
Patients who had arrhythmia causing clinical symptoms such as dyspnea or palpitation within the last 6 months.
The range of pulse rate - under 55/min or exceed 120/min