Efficacy and Safety of SP-8203 (Otaplimastat) in Patients With Acute Ischemic Stroke Receiving Thrombolytic Standard of Care
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Ischemic Stroke
In brief
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.
Key facts
- Study ID
- NCT06660719
- Run by
- Shin Poong Pharmaceutical Co. Ltd.
- People needed
- 852
- Starts
- 2025-02-14
- Expected to finish
- 2027-03-30
- Last updated by the study team
- 2025-03-07
Who can join
Age: 19 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 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 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 with decreased hemoglobin (Hb< 10g/dL), decreased platelet count (PLT< 100,000/mm3) or hematocrit of <25% in complete blood count.
- Patients who have undergone hemodialysis and/or treatments due to nephropathies, acute or chronic renal failure at screening.
- 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 do not consent to use double barrier contraception until 90 days from the first study intervention administration.
- 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 who cannot participate in the study at the discretion of investigators
- Patients who are unable to receive thrombolytic standard of care, rtPA
Where it is running
- Dong-A University Hospital — Busan, South Korea (enrolling)
- Ulsan University Hospital — Ulsan, South Korea (enrolling)
Full record on ClinicalTrials.gov
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