Tests SP-8203 with clot-busting treatment in people having an acute ischemic stroke
Tests SP-8203 alongside standard clot-busting treatment in adults having an acute stroke.
Plain-language title generated from the registry record
Registry title: Efficacy and Safety of SP-8203 (Otaplimastat) in Patients With Acute Ischemic Stroke Receiving Thrombolytic Standard of Care
Key facts
- Where
- Busan and Ulsan, South KoreaSee the 2 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 19 and 85 years old?
Source: NCT06660719, who can take part
Where in South Korea
- Dong-A University HospitalBusan, South KoreaTaking people
- Ulsan University HospitalUlsan, South KoreaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Shin Poong Pharmaceutical Co. Ltd.
- Trial code
- NCT06660719
- Record updated
- 7 March 2025
- Original description
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.Read full original descriptionShow less
A Multi-Center, Randomized, Double-Blind, Parallel, Placebo-Controlled, Phase III Clinical Study to Evaluate Efficacy and Safety of SP-8203 (Otaplimastat) in Patients With Acute Ischemic Stroke Requiring Thrombolytic Therapy as Standard of Care
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.
Inclusion: 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 available for brain Magnetic Resonance Imaging (MRI) scanning; Patients who consent to participate in this study.
Exclusion: Patients with a cancer in following conditions: diagnosed within 6 months before the screening time, or any treatment for cancer within the previous 6 months, or with recurrent/ metastatic cancer; Pregnant and lactating women. However, Women of Childbearing Potential (WOCBP) can participate in the study only when non-pregnancy is confirmed. Women of Childbearing Potential (WOCBP) is defined as woman who is not definitely menopause and did not receive a surgical contraception; Patients who have participated in other clinical trials of other drugs within the past 3 months. However, if they participated in observational studies and did not take drugs, they can participate in this trial; 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; Patients with severe heart failure of New York Heart Association (NYHA) Class III or Class IV; Patients with fever (≥ 38℃) or infection signs which require antibiotic therapy at screening; Patients with pulmonary diseases (asthma, Chronic Obstruction Pulmonary disease, and active tuberculosis etc.) who have being recently been treated more than 1 month at screening; Patients who have undergone hemodialysis and/or treatments due to nephropathies, acute or chronic renal failure at screening; Patients showing the following abnormal ECG findings in stable condition at Emergency Room:; The range of pulse rate - under 55/min or exceed 120/min; 2nd or 3rd degree Atrioventricular (AV) block indicated in ECG; Congenital or acquired QT syndrome indicated in ECG; Pre-excitation syndrome indicated in ECG; Patients with decreased hemoglobin (Hb< 10g/dL), decreased platelet count (PLT< 100,000/mm3) or hematocrit of <25% in complete blood count; Patients who do not consent to use double barrier contraception until 90 days from the first study intervention administration; Patients who cannot participate in the study at the discretion of investigators; Patients who are unable to receive thrombolytic standard of care, rtPA.