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
Parallel
SP-8203
DrugSP-8203 80 mg will be intravenously administered as 40 mg/dose twice daily (intervals of 12 hours)
Placebo
DrugPlacebo will be intravenously administered twice daily (intervals of 12 hours)
Proportion of participants with modified Rankin Scale (mRS) 0-1
Proportion of participants with modified Rankin Scale (mRS) 0-1 at Day 90 in patients with acute ischemic stroke requiring thrombolytic standard of care
Incidence of parenchymal hematoma observed on brain Computed Tomography (CT) scan
Incidence of parenchymal hematoma observed on brain Computed Tomography (CT) scan performed at 24±3 hours in accordance with European Cooperative Acute Stroke Study (ECASS) I and II criteria, after the administration of SP-8203 in conjunction with thrombolytic standard of care
Proportion of participants with modified Rankin Scale (mRS) 0-1
Proportion of participants with modified Rankin Scale (mRS) 0-1 at Day 30 in patients with acute ischemic stroke requiring thrombolytic standard of care
Proportion of participants with modified Rankin Scale (mRS) 0-2
Proportion of participants with modified Rankin Scale (mRS) 0-2 at Day 30 and Day 90 in the patients with acute ischemic stroke requiring thrombolytic standard of care
Change from Baseline in National Institute of Health Stroke Scale (NIHSS) scores
The change in the National Institute of Health Stroke Scale (NIHSS) scores until 90 day in subjects with acute ischemic stroke requiring rtPA standard of care. The maximum total score is 42 points, which indicates the most critical condition and the minimum total score is 0, which indicates no neurologic deficit.
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