EUCTR2005-003176-38-HU进行中（未招募）不适用
A placebo controlled trial of alteplase (rt-PA) in acute ischemic hemispheric stroke where thrombolysis is initiated between 3 and 4 hours 30 minutes after stroke onset - ECASS III
Boehringer Ingelheim Pharma Ges mbH0 个研究点目标入组 800 人开始时间: 2005年12月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 800
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Female or male inpatients
- •18 - 80 completed years
- •Clinical diagnosis of ischemic stroke causing a measurable neurological deficit as impairment of language, motor function, cognition and/or gaze, vision or neglect. Ischemic stroke is defined as an event characterized by the sudden onset of an acute focal neurologic deficit presumed to be due to cerebral ischemia after CT scan excludes hemorrhage
- •Onset of symptoms between 3 and 4 hours 30 minutes prior to initiation of administration of study drug
- •Stroke symptoms are to be present for at least 30 minutes and have not significantly
- •improved before treatment. Symptoms must be distinguishable from an episode of generalized ischemia, seizure, or migraine disorder.
- •Patient is willing to participate voluntarily and to sign a written patient informed consent. Informed consent will be obtained from each patient or the subject's legally authorized representative or relatives, or defered where applicable, according to the regulathory and legal requirements of the participating country.
- •Patients who are unable to sign but who are able to understand the meaning of participation in the study may give an oral witnessed informed consent. These patients have to make clear undoubtfully that they are willing to participate voluntarily and must be able to understand an explanation of the contents of the information sheet.
- •Willingness and ability to comply with the protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Evidence of intracranial hemorrhage on the CT - scan
- •Symptoms of ischaemic attack began more than 4 hours prior to infusion start or when time of symptom onset is unknown
- •Minor neurological deficit or symptoms rapidly improving before start of infusion
- •Severe stroke as assessed clinically and/or by appropriate imaging techniques
- •Epileptic seizure at onset of stroke
- •Symptoms suggestive of subarachnoid haemorrhage, even if the CT - scan is normal.
- •Administration of heparin within the previous 48 hours and a thromboplastin time exceeding the upper limit of normal for laboratory
- •Patients with any history of prior stroke within the last 3 months
- •Platelet count below 100,000/mm3
研究者
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