Clinical Trial

Efficacy and Safety of SP-8203 (Otaplimastat) in Patients With Acute Ischemic Stroke Receiving Thrombolytic Standard of Care

Study acronym: SP-8203-3001
Recruiting Phase 3
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Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-10-25.
Status change: Not Yet Recruiting → Recruiting 2025-03-04
Trial Details
NCT Number NCT06660719
Lead Sponsor Shin Poong Pharmaceutical Co. Ltd.
Conditions Ischemic Stroke
Enrollment 852 participants
Start Date 2025-02-14
Primary Completion 2027-03-30 (estimated)
Study Completion 2027-03-30 (estimated)
Updated on ClinicalTrials.gov 2025-03-07