EUCTR2015-003179-32-GR进行中（未招募）1 期
PREvention of Complications to Improve Outcome in elderly patients with acute Stroke. A randomised, open, phase III, clinical trial with blinded outcome assessment. - PRECIOUS
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 3,800
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
- •1. A clinical diagnosis of acute ischaemic stroke or intracerebral haemorrhage, confirmed with CT or MRI scan. A normal CT scan is considered compatible with ischaemic stroke;
- •2. A score on the National Institutes of Health Stroke Scale (NIHSS) = 6, indicating moderately severe to severe stroke;
- •3. Age 66 years or older;
- •4. The possibility to start treatment within 12 hours of symptom onset;
- •5. Written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •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 3800
排除标准
- •1. Active infection requiring antibiotic treatment, as judged by the treating physician;
- •2. Clinical indication for one or more of the drugs tested in this patient;
- •3. Pre-stroke score on the mRS =4;
- •4. Death appearing imminent at the time of assessment.
- •In addition, patients will be excluded from participation in the trial treatment arms for any of the following reasons:
- •For the ceftriaxone arm:
- •1. Known hypersensitivity to beta-lactam antibiotics;
- •For the paracetamol arm:
- •1. Known hypersensitivity to paracetamol or any of the excipients;
- •2. Known severe hepatic insufficiency;
- •3. Chronic alcoholism
- •For the metoclopramide arm:
- •1. Hypersensitivity to the metoclopramide or to any of the excipients;
- •2. Gastrointestinal haemorrhage, mechanical obstruction or gastro-intestinal perforation for which the stimulation of gastrointestinal motility constitutes a risk;
- •3. Confirmed or suspected pheochromocytoma;
- •4. History of neuroleptic or metoclopramide-induced tardive dyskinesia;
- •5. Epilepsy;
- •6. Parkinson's disease;
- •7. Use of levodopa or dopaminergic agonists;
- •8. Known history of methaemoglobinaemia with metoclopramide or of NADH cytochrome-b5 deficiency.
研究者
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