KCT0002120招募中未知
A Prospective, Randomized, Double-blinded Phase IIa Clinical Trial to Investigate the Safety and Efficacy of Two Doses of SP-8203 in Patients With Ischemic Stroke Requiring rtPA Standard of Care.
Shin Poong Pharm0 个研究点目标入组 80 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 80(Year)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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,
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