JPRN-jRCT2051190092进行中（未招募）2 期
A study to evaluate safety and optimal dose/administration of adrenomedullin in patients with acute non-embolic ischemic stroke
IHARA MASAFUMI0 个研究点目标入组 60 人开始时间: 2020年1月8日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 90age old（—）
- 性别
- All
入选标准
- •1) Patients who have given written informed consent from the patient or the sponsor to participate in the clinical trial
- •2) Patients of the following age
- •(1) Up to 6 patients in both cohorts: age between 20 and 75 at the time of obtaining consent
- •(2) In both cohorts, after age restriction has been lifted: Patients aged 20 to 90 at the time of consent acquisition
- •3) Patients who can start study drug administration within 24 hours after onset of ischemic stroke
- •(If the time of onset is unknown, the time last seen normal is the time of onset.)
- •4) Patients with a new ischemic area confirmed by MRI-DWI
- •5) Patients with NIHSS scores of 1 or above
排除标准
- •1) Patients with ischemic stroke of embolic etiology
- •2) Patients who are likely to develop hemorrhagic transformation (patients with extensive ischemic stroke)
- •3) Patients who have premorbid mRS scores of 3 or more
- •4) Patients with active infections
- •5) Patients who have received or are scheduled to receive drugs or therapy (endovascular treatment, surgical treatment, etc.) not allowed to be used for the underlying disease
- •6) Patients with severe consciousness impairment (Japan Coma Scale 100 or more)
- •7) Patients with severe renal impairment (estimated GFR less than 30 mL / min / 1.73m2)
- •8) Patients with severe liver damage (transaminase AST (GOT) or ALT (GPT) 100 IU / L or more)
- •9) Patients diagnosed as having active intracranial bleeding disease (intracranial hemorrhage, subarachnoid hemorrhage, etc.) or ruptured cerebral aneurysm by head MRI taken after onset
- •10) Patients with severe stenosis and obstruction of the basilar artery, internal carotid artery, and middle cerebral artery horizontal part considered to be the cause of cerebral infarction targeted in this study
- •11) Patients with significant ECG abnormalities (atrioventricular block of 2-3 degrees, extension of QRS interval of 120 ms or more, extension of QTcB of 450 msec or more), or clinically significant heart disease (heart failure, myocardial infarction) , Angina pectoris)
- •12) Patients with systolic blood pressure less than 120 mmHg
- •13) Patients whose pulse rate is less than 45 beats / minute or 120 beats / minute or more
- •14) Patients with substance abuse or alcoholism
- •15) Patients who cannot perform MRI
- •16) Patients with malignant tumors or patients who have been treated for malignant tumors
- •17) Patients who do not give consent to contraception from the date of obtaining consent until the end of the safety evaluation period
- •18) Pregnant, lactating, and possibly pregnant
- •19) Patient who participated in another trial within 24 weeks before obtaining consent
- •20) Patients who have participated in clinical trials or clinical studies using adrenomedullin
- •21) Patients weighing 100 kg or more (rounded to one decimal place)
- •22) Other patients judged by the Investigator or Investigator to be ineligible for this study
研究者
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