Safety and Efficacy of Two Doses of SP-8203 in Patients With Ischemic Stroke.
- Conditions
- Diseases of the nervous system
- Registration Number
- KCT0002120
- Lead Sponsor
- Shin Poong Pharm
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 80
Stage 1-specific Criteria
Patients with neurologic deficit of =4 points and =10 points by NIHSS score.
Stage 2-specific Criteria
Patients with neurologic deficit of =4 points by NIHSS score.
Common Criteria for Stage 1 and Stage 2
1. Adults aged =19 years and =80 years.
2. Subjects who can receive rtPA therapy within 4.5hours after the onset of early symptoms of acute ischemic stroke
3. Subjects available for brain MRI (DWI[Diffusion Weighted Image], GRE[Gradient Echo Image]//SWI [Susceptibility Weighted Imaging], FLAIR[Fluid-attenuated inversion recovery], MRA[Magnetic resonance angiography]) scanning
4. Subjects who consent to participate in this trial.
1) Patients with systemic allergic diseases or hypersensitivity to specific drugs.
2) Patients have condition as follows:
(1) Patients who were diagnosed with acute myocardial infarction (AMI) within the last 6 months.
(2) Patients who had arrhythmia causing symptoms such as dyspnea or palpitation within the last 6 months.
(3) Patients showing the following abnormal ECG findings in stable condition at screening:
?The range of pulse rate – under 55/min or exceed 120/min
A subject is excluded when his/her pulse rate, measured in both hand and ECG, is under 55/min.
? 2nd or 3rd degree AV(Atrioventricular) block indicated in ECG
? Congenital or acquired QT syndrome indicated in ECG
? Pre-excitation syndrome indicated in ECG
3) Patients with severe heart failure of NYHA(New York Heart Association) Class III or Class IV.
NYHA classification of heart failure defined as:
-Class I: patients with no limitation of activities; they suffer no symptoms from ordinary activities.
-Class II: patients with slight, mild limitation of activity; they are comfortable with rest or with mild exertion.
-Class III: patients with marked limitation of activity; they are comfortable only at rest.
-Class IV: patients who should be at complete rest, confined to bed or chair; any physical activity brings on.
4) Patients with fever (= 38?) or infection signs which require antibiotics at screening
5) Patients with pulmonary diseases (asthma, COPD[Chronic Obstructive PulmonaryDisease ], and active tuberculosis etc.) who have being recently been treated more than1 month at screening
6) Patients showing the following hematological findings: Patients with decreased hemoglobin (Hb< 10g/dL), decreased platelet count (PLT< 100,000/mm3) or hematocrit of <25% in complete blood count .
7) Patients who have undergone hemodialysis and/or treatments due to nephropathies,acute or chronic renal failure at screening.
8) 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.
9) Pregnant and breast-feeding women. However, women of childbearing age can participate in the trial only when non-pregnancy is confirmed. Woman of childbearing age is defined as woman who is not definitely menopause and did not receive a surgical contraception.
10) Patients who do not consent to use double barrier contraception during the trial period.
11) 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.
12) Patients who cannot participate in the trial according to the judgment of investigators.
13) Patients with contraindication for the use of rtPA as shown in the below.
[Contraindication for the Use of rtPA]
A. Patients with hypersensitivity to gentamycin
B. rtPA should not be administered when the risk of bleeding is high as follows:
i. Patients who suffered from significant hemorrhagic diseases within the past 6 months or with known hemorrhagic diathesis.
ii. Patients receiving oral anticoagulants such as warfarin sodium (INR>1.3).
iii. Patients with apparent hemorrhage or recent serious or risky hemorrhage.
iv. Patients with the past history of tumor, aneurysm, or central nervous system damage such as intracranial or intraspinal operation.
v. Patients with hemorrhagic retinopathy,
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of parenchymal hematoma observed on brain CT scan performed at 24 hours in accordance with European Cooperative Acute Stroke Study (ECASS) I and II criteria, after the administration of SP-8203 in conjunction with rtPA standard of care
- Secondary Outcome Measures
Name Time Method Incidence rate of serious adverse event ;Neurologic chages evaluated by modified Rankin Scale (mRS). ;Incidence rate symptomatic intracranial hemorrhage (SICH) occuring within 5 days. ;Neurologic changes evaluated by NIHSS. ;Neurologic changes evaluated by Barthel Index. ;The rate of death due to any cause. ;Incidence rate of adverse events and adverse durg reactions. ;Incidence rate of major systemic bleeding according to the International Society of Thrombosis and Hemostasis on Thrombosis and Hemostasis.