Citicoline in the Treatment of Acute Ischemic Stroke. An International Randomized Multicenter Placebo-controlled Study
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 2,298
- 试验地点
- 64
- 主要终点
- Total recovery at three months of onset, based on a global test analysis including NIHSS, mRS and Barthel Index
研究概览
简要总结
Citicoline is a safe drug approved in some countries for the treatment of acute ischemic stroke. The drug has shown some evidence of efficacy in a pooled analysis, based on four clinical trials done in USA with oral citicoline.The purpose of the study is confirm the results obtained in the pooled analysis, that is, evidence of efficacy in the treatment of acute ischemic stroke
详细描述
The stroke or brain attack is one of the main health problems in developed countries. It is the third cause for death and the main cause of disability in adults. Cerebral infarction makes up 80 % of all the types of strokes.
After a stroke, different evolutions and outcomes can be observed, and there are several factors that may influence the outcome, such as age, cognitive impairment, and psycho-social factors. The most important prognostic factors for acute ischemic stroke are the volume of the cerebral infarction and the severity of the baseline neurological deficit.
In recent years, stroke has been considered a real medical emergency, and for this reason several clinical trials have been conducted to find effective therapies. Among pharmacological therapies, there are two possible ways to treat ischemic strokes: treatments directed to recanalize the occluded artery, such as thrombolysis, and the neuroprotective drugs.
None of the neuroprotective drugs have attained the international approval for this indication. Among the reasons for the failures obtained with the different drugs tested, we must highlight the problems derived from the toxicity of the drugs and from the evaluation criteria, as well as the therapeutic window used.
To evaluate a drug in the treatment of acute ischemic stroke, one must be very careful when defining the schedule of the clinical trial, and which variable or variables may be considered as primary endpoints. Several endpoints have been used in the different clinical trials developed, although the most used are those referring to the functional status and the degree of disability of the patients, normally set at 3 months after the stroke.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Male or female, >18 years old
- •Patients must be treated within 24 hours of their initial stroke symptoms onset.
- •Patients with a measurable focal neurological deficit lasting for a minimum of 60 minutes.
- •Patients must have a CT scan and/or conventional MRI compatible with the clinical diagnosis of acute ischemic stroke prior to being randomized.
- •Patients must have an acute ischemic stroke referable to the middle cerebral artery territory
- •At inclusion, NIHSS score > 7, with at least 2 of these points from sections 5 & 6 (motor)
- •Immediately (i.e. minutes) pre-stroke, MRS < 2
- •Women of childbearing potential must have a negative pregnancy test prior to enrolment
- •Signed informed consent
排除标准
- •Patients in coma: patients having a score of 2 or higher in the items regarding the level of consciousness in the NIHSS (1a)
- •CT or conventional MRI evidence of brain tumor, cerebral edema with a clinically significant mass midline shift with compression of the ventricles, brainstem or cerebellar infarction, subarachnoid and/or intracerebral and/or intraventricular hemorrhage
- •History of ventricular dysrhythmias, acute myocardial infarction within 72 hours prior to enrolment, unstable angina, decompensated congestive heart failure or any other acute, severe, uncontrollable or sustained cardiovascular condition that, in the Investigator's opinion, may interfere with effective participation in the study
- •Previous disorders that may confound the interpretation of the neurological scales
- •Drug addiction-related disorders
- •Pre existing dementia, when dementia implies a disability, measured as an score of 2 or higher in the previous MRS
- •Pre existing medical condition that, in the Investigator's opinion, may interfere with the patient's suitability and participation in the study
- •Patients participating in another clinical trial or receiving a non-approved drug (clinical investigational drug) less than 30 days prior to screening
- •Patients under current treatment with citicoline
研究组 & 干预措施
Active
Receives active drug
干预措施: Citicoline (Drug)
Placebo
Receives a placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Total recovery at three months of onset, based on a global test analysis including NIHSS, mRS and Barthel Index
时间窗: 3 months
次要结局
- mRS at 3 months(3 months)
- Barthel Index at 3 months(3 months)
- Safety and tolerability(3 months)