Citicoline in Ischemic Stroke, a Randomized Placebo-controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Value of Montreal Cognitive Assessment (MoCA)
研究概览
简要总结
Along with the current clinical trial, the efficacy and safety of a 1000 mg daily citicoline administered within 24 hours of the first-ever ischemic stroke and lasted 12 months compared to placebo were assessed through MoCA, NIHSS, mRS, and possible adverse effects.
详细描述
The investigators conducted a single-blinded, placebo-controlled, randomized controlled trial between December 2023 and December 2024 after approval of the ethical committee of the faculty of medicine at Kafr el-Sheik University.
The investigators got written informed consent from all eligible patients or their first order of kin before randomization.
The study will comprise 2 arms citicoline arm, which consists of 400 patients who received 1000 mg citicoline once daily for 12 months, and the placebo arm, consisting of 400 patients who received a placebo once daily for 12 months; all the patients in the two groups received open-label double antiplatelet in the form of 75 mg aspirin. and 75 mg clopidogrel for three weeks, followed by a single antiplatelet in the form of 75 mg clopidogrel for the rest of our trial.
Study Procedures:
Every patient in our study will undergo:
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
- Double (Participant, Outcomes Assessor)
盲法说明
An independent statistician generated a blocked randomization sequence using computer-generated random numbers; in a one-to-one ratio, a specially trained and qualified nurse randomly assigned participants to receive either citicoline or a placebo. We prepared Sequentially numbered opaque sealed envelopes and 800 labels for each drug labeled Drug A or B. According to the randomization chart, put them into envelopes numbered 1 to 800. Envelopes were attached to the patient's files. Patients were recruited sequentially and were given enrolment numbers starting from 1, which were mentioned on their files. Files with the same number as the patient enrolment number were opened, and the patients were assigned to receive drugs A or B. Drug A included citicoline, and Drug B included a placebo. The statistical analysis was performed by an independent statistician who did not know the treatment protocol of groups A or B.
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
- •Male & female patients will be included
- •Age more than 18 years.
- •Patients must be treated within the first 24 hours of their initial stroke symptoms onset.
- •Patients not eligible to receive TPA.
- •Patients with a measurable focal neurological deficit (NIHSS score ≥ 4 and less than 21) lasting at least 60 minutes.This deficit must persist from the onset and up to the time of treatment without clinically significant improvement
排除标准
- •Patients eligible for rTPA treatment.
- •Patients with any type of aphasia
- •Patients in coma: patients having a score of 2 or higher in the items regarding the level of consciousness in the NIHSS.
- •CT or conventional MRI evidence of any structural brain disorder other than ischemic stroke.
- •History of ventricular dysrhythmias, acute myocardial infarction within 72 hours before 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 a score of 2 or higher in the previous mRS.
- •Patients under current treatment with citicoline.
- •concomitant administration of other neuroprotectant drugs (such as nimodipine, vinpocetine, piracetam, cerebrolysine).
研究组 & 干预措施
citicoline 2000 mg arm
The citicoline arm consists of 400 patients who received 2000 mg citicoline once daily for 12 months and an open-label double antiplatelet in the form of 75 mg aspirin and 75 mg clopidogrel for three weeks, followed by a single antiplatelet in the form of 75 mg clopidogrel for the rest of our trial.
干预措施: Citicoline 2000 (Drug)
citicoline 1000 mg arm
The placebo arm consists of 400 patients who received citicoline 1000mg daily for 12 months and an open-label double antiplatelet in the form of 75 mg aspirin and 75 mg clopidogrel for three weeks, followed by a single antiplatelet in the form of 75 mg clopidogrel for the rest of our trial.
干预措施: citocoline 1000 (Drug)
结局指标
主要结局
Value of Montreal Cognitive Assessment (MoCA)
时间窗: 6 months
MoCA is a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. Its score ranges from zero to 30 points; the normal value is from 26 to 30; mild cognitive impairment ranges from 18 to 25, Moderate cognitive impairment ranges from 10 to 17, and severe cognitive impairment is below 10 points.
Rate of drug-related complications after 6 months
时间窗: 6 months
All side effects related to the drugs in our study will be reported
次要结局
- Rate of drug-related complications after 12 months(12 months)
- Value of Modified Rankin Scale (mRS) at 6 months(6 months)
- Value of Modified Rankin Scale (mRS) at 12 months(12 months)
- Value of Montreal Cognitive Assessment (MoCA)(12 months)
研究者
Mohamed G. zeinhom, MD
Dr.
Kafrelsheikh University