Efficacy and Safety of SP-8203 (Otaplimastat) in Patients With Acute Ischemic Stroke Receiving Thrombolytic Standard of Care
Recruiting
Phase 3Interventional Study
Ischemic Stroke
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
19 – 85
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
852 (estimated)
Sponsor
Shin Poong Pharmaceutical Co. Ltd. · Industry
Who this trial is looking for
This trial is looking for adults who have had an acute ischemic stroke and are receiving standard treatment. Participants will be given a new treatment alongside their usual care to see how well it works and if it is safe.
Are You a Good Fit for This Trial?
Rules you outCancer diagnosed in the last 6 monthsSevere heart diseaseSevere lung disease
You may be able to join if
I have a neurologic deficit of 8 or more on the NIH Stroke Scale.
I was able to carry out my usual activities before the stroke.
I am between 19 and 85 years old.
I can receive standard thrombolytic treatment within 4.5 hours of stroke symptoms.
I am available for a brain MRI scan.
I agree to participate in this study.
You may not be able to join if
I have had a heart attack in the last 6 months.
I have experienced serious heart rhythm problems in the last 6 months.
I have severe heart failure.
I have signs of infection that require antibiotics.
I have a history of certain serious lung diseases recently.
I have low hemoglobin or platelet counts.
I am pregnant or breastfeeding.
I do not agree to use contraception for 90 days after the treatment.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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…
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.
Trial Locations
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Status
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 …
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
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