Actively Recruiting
Efficacy and Safety of SP-8203 (Otaplimastat) in Patients With Acute Ischemic Stroke Receiving Thrombolytic Standard of Care
Led by Shin Poong Pharmaceutical Co. Ltd. · Updated on 2025-03-07
852
Participants Needed
2
Research Sites
110 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy and Safety of SP-8203 (Otaplimastat) in Patients With Acute Ischemic Stroke Receiving Thrombolytic Standard of Care
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with neurological deficit of 8 points or more on the National Institute of Health Stroke Scale (NIHSS)
- Patients with pre-stroke modified Rankin Scale (mRS) of 0 or 1, indicating full ability to perform usual activities
- Adults aged 19 to 85 years
- Patients able to receive thrombolytic standard of care within 4.5 hours after stroke symptom onset
- Patients able to undergo brain Magnetic Resonance Imaging (MRI) scanning
- Patients who consent to participate in the study
You will not qualify if you...
- Patients with systemic allergic diseases or hypersensitivity to specific drugs
- Patients diagnosed with myocardial infarction within the last 6 months
- Patients with symptomatic arrhythmia such as dyspnea or palpitation in the last 6 months
- Patients with abnormal ECG findings including pulse rate under 55/min or over 120/min, 2nd or 3rd degree AV block, congenital or acquired QT syndrome, or pre-excitation syndrome
- Patients with severe heart failure classified as NYHA Class III or IV
- Patients with fever (temperature 38daC) or infection requiring antibiotics at screening
- Patients with recent pulmonary diseases treated for more than 1 month at screening
- Patients with low hemoglobin (Hb < 10 g/dL), low platelet count (PLT < 100,000/mm3), or hematocrit < 25%
- Patients undergoing hemodialysis or treatment for acute or chronic kidney failure
- Patients with recent cancer diagnosis or treatment within 6 months, or recurrent/metastatic cancer
- Pregnant or breastfeeding women; women of childbearing potential must confirm non-pregnancy
- Patients who do not agree to use double barrier contraception for 90 days from first intervention
- Patients who participated in other drug clinical trials within the past 3 months (except observational studies without drug use)
- Patients unable to receive thrombolytic standard of care, such as rtPA
- Patients deemed unable to participate by investigators
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Dong-A University Hospital
Busan, South Korea, 49201
Actively Recruiting
2
Ulsan University Hospital
Ulsan, South Korea, 44033
Actively Recruiting
Research Team
J
Jong Sung Kim, MD, Phd
CONTACT
B
Byung Su Kim, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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