NCT00044057已完成2 期
A Multicenter, Stratified, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Neurologic Function and Disability in Patients With Acute Ischemic Stroke Given Tissue Plasminogen Activator Plus YM872 or Tissue Plasminogen Activator Plus Placebo
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 118
研究概览
简要总结
The purpose of this study is to determine if YM872 in combination with t-PA can reduce disability and brain damage from stroke. YM872 or placebo will be given as a continuous intravenous (iv) infusion for 24 hours. It is important that the study medication, YM872 or placebo, is administered prior to the completion of the t-PA administration. The clinical effects of YM872 in addition to t-PA will be determined by assessing neurological function and disability scores at follow up visits through Day 90 of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with acute ischemic stroke who are treated with alteplase within 3 hours of stroke onset (Onset is defined as the time that which the patient was last seen in a normal state, or bedtime for unwitnessed strokes occurring during the night).
- •Patients who are able to provide written informed consent or have consent provided by a legally authorized representative.
- •Patients who are at least 18 years of age.
- •Patients who have a National Institutes of Health Stroke Scale (NIHSS) score of at least 7 but not more than 23 and who are conscious.
- •Other criteria as specified in the study protocol
排除标准
- •Patients who are not eligible to receive treatment with alteplase (t-PA) due to brain hemorrhage, risk for hemorrhage, or other criteria.
- •Patients who have stroke of the brainstem or cerebellum.
- •Patients who have renal (kidney) disease or insufficiency.
- •Patients who have active epilepsy or convulsions during the current stroke episode.
- •Patients who are IV drug users or are inebriated.
- •Patients who have a history of drug-related anaphylaxis.
- •Patients who have taken sedatives, anticonvulsants, or any medication with sedating effects in the 10 days prior study enrollment.
- •Patients who have taken more than 1.3 g of aspirin per day in the 2 days prior to enrollment.
- •Patients who have a known vitamin hypersensitivity.
- •Other exclusion criteria as specified by the study protocol
研究者
研究点 (118)
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