Non-interventional Prospective Observational Study of Efficacy and Safety of Cytoflavin in Combination With Reperfusion Compared to Treatment With Other Neuroprotective Drugs Used in Routine Clinical Practice in Patients With Cerebral Infarction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 7
- 主要终点
- Proportion of patients with good functional outcome
研究概览
简要总结
Evaluation of the efficacy and safety of Cytoflavin®, solution for intravenous administration, (OOO NTFF POLYSAN, Russia) for 10 days, patients with cerebral infarction who receive reperfusion therapy, with the start of treatment within the first 24 hours from the stroke onset, compared to treament with any other neuroprotective drug which may be used in routine clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed Informed Consent;
- •Men and women 18-85 y.o.;
- •A diagnosis of "cerebral infarction" has been established and treatment with Cytoflavin® has already been prescribed, or other therapy has been prescribed that does not include Cytoflavin®;
- •NIHSS score of at least 5 and less than 24;
- •reperfusion therapy performed on admission;
- •The size of the ischemic focus according to ASPECTS score >=6;
- •Time from stroke onset to admission not exceeeding 6 hours;
- •Start of therapy with Cytoflavin® within 24 hours from the onset of stroke (main group);
- •Patients who are able to follow the procedures of the Observational Study Program and strictly follow the doctor's instructions regarding drug therapy.
排除标准
- •Individual intolerance or known hypersensitivity to succinic acid, inosine, nicotinamide, riboflavin, or auxiliary components of the drug Cytoflavin®;
- •Hemorrhagic stroke;
- •Contraindications for CT scanning;
- •Initial severe disability requiring assistance in everyday life before stroke;
- •previous stroke with a residual neurological deficit;
- •Severe comorbidity with a life expectancy of less than 6 months;
- •Clinical or laboratory signs of an infectious disease on admission (with the exception of strokes that occurred in COVID-19 convalescents after the first 10 days of illness, and patients with asymptomatic SARS-CoV-2 infection detected during routine examination);
- •Pregnancy or lactation
研究组 & 干预措施
Cytoflavin
Patients who underwent reperfusion for acute stroke (intravenous thrombolysis and/or mechanical thrombectomy) and receive intravenous Cytoflavin® at a discretion of the physician, starting this treatment within the first 24 hours from the onset of stroke
干预措施: Cytoflavin (succinic acid + inosine + nicotinamide + riboflavin) (Drug)
Control
Patients who underwent reperfusion for acute stroke (intravenous thrombolysis and/or mechanical thrombectomy) and do not receive Cytoflavin as part of their routine clinical practice, but may receive any other neuroprotective medications.
干预措施: Control (Drug)
结局指标
主要结局
Proportion of patients with good functional outcome
时间窗: 90 days
Proportion of patients who achieve score 0-2 by modified Rankin scale
次要结局
未报告次要终点