NCT06660719 Efficacy and Safety of SP-8203 (Otaplimastat) in Patients With Acute Ischemic Stroke Receiving Thrombolytic Standard of Care
| NCT ID | NCT06660719 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Shin Poong Pharmaceutical Co. Ltd. |
| Condition | Ischemic Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 852 participants |
| Start Date | 2025-02-14 |
| Primary Completion | 2027-03-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 852 participants in total. It began in 2025-02-14 with a primary completion date of 2027-03-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Jong Sung Kim, MD, Phd
STUDY CHAIR
GangNeung Asan Medical Center
Frequently Asked Questions
Who can join the NCT06660719 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, up to 85 Years, studying Ischemic Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06660719 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 852 participants.
Is NCT06660719 currently recruiting?
Yes, NCT06660719 is actively recruiting participants. Contact the research team at jongskim@amc.seoul.kr for enrollment information.
Where is the NCT06660719 trial being conducted?
This trial is being conducted at Busan, South Korea, Ulsan, South Korea.
Who is sponsoring the NCT06660719 clinical trial?
NCT06660719 is sponsored by Shin Poong Pharmaceutical Co. Ltd.. The principal investigator is Jong Sung Kim, MD, Phd at GangNeung Asan Medical Center. The trial plans to enroll 852 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.