NCT03252626尚未招募4 期
Study on the Efficacy of Alprostadil Injection in Patients With Acute Ischemic Stroke
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 950
- 主要终点
- Modified Rankin Scale at Day 90
研究概览
简要总结
Ischemic stroke has a variety of treatments and currently drug therapy is one of the main treatments.A number of clinical studies have proved that alprostadil (PGE1) has pharmacological effects of significant dilation of blood vessels, inhibition of plate aggregation, anti-atherosclerosis and increased cerebral blood flow.Evaluate the 90-days efficacy by comparing two groups of patients'(one with alprostadil,another with placebo) mRS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ischemic stroke diagnosed by CT or MRI
- •Age: 18-75 years
- •Pre-stroke mRS score is 0-1
- •within 72 hours symptoms onset
- •4 ≤ NIHSS <20
- •Patient is willing to participate voluntarily and to sign a written patient informed consent
排除标准
- •intracranial tumors, encephalitis or lesions diagnosed by CT or MRI
- •patients with thrombolytic therapy
- •low platelet , blood system diseases or other bleeding tendency
- •suspected subarachnoid hemorrhage or aortic dissection coma
- •atrial fibrillation, myocardial infarction, heart valve disease, infective endocarditis, heart rate <50 beats / min
- •ALT or AST continued to rise more than 3 times the upper limit of normal creatinine clearance rate<30ml/min
- •Dementia and mental illness
- •Patient who is participating in other trials or has been participated in other trials in recent 3 months
研究组 & 干预措施
Alprostadil
Active Comparator
Based on the standard medical care, 2ml of Alprostadil
干预措施: Alprostadil (Drug)
Normal saline
Placebo Comparator
Based on the standard medical care, 2ml of 0.9% saline as the placebo
干预措施: Normal saline (Drug)
结局指标
主要结局
Modified Rankin Scale at Day 90
时间窗: day 90
次要结局
- EQ-5D scale(day 30, day 90)
- Incidence of major vascular events in 30 or 90 days including ischemic stroke and hemorrhagic stroke(day 30, day 90)
- Barthel Index score(day 30, day 90)
- Documentation of adverse events (AEs)(day 30, day 90)
- Incidence of stroke events in 30 or 90 days including ischemic stroke and hemorrhagic stroke(day 30, day 90)
研究者
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