Single-center Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of Polyprenols (ROPREN) in Subjects With Acute Coronary Syndrome
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Сardiospecific enzymes
研究概览
简要总结
The aim of this study is to determine efficacy and safety of polyprenols (ROPREN) using in patients with acute coronary syndrome
详细描述
This study is randomized double blind placebo controlled. Patients with acute coronary syndrome taking standard therapy including atorvastatin 40 mg/day were randomized into 2 groups: group 1 takes Ropren 8 drops 3 times per day for 3 week, then 5 drops 3 times per day for 5 weeks; group 2 take placebo in the same dose regimen. The hepatoprotective, hypolipidemic, antiinflammatory, cognitive, antidepression functions evaluates after one and two - month therapy
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
- •Acute coronary syndrome
- •Informed consent received
排除标准
- •Patient's incapacity to take accurately drops by oneself
- •Cardiogenic shock
研究组 & 干预措施
Placebo Group
Oil: 8 drops 3 times per day for 3 weeks, then 5 drops 3 times per day for 5 weeks
干预措施: Oil (Other)
Polyprenol Group
Polyprenols (ROPREN): 8 drops 3 times per day for 3 weeks, then 5 drops 3 times per day for 5 weeks
干预措施: Ropren (Drug)
结局指标
主要结局
Сardiospecific enzymes
时间窗: At 9 days after acute coronary syndrome
The levels of CK, CK-MB, Troponin I
Inflammatory enzymes
时间窗: At 2 months after acute coronary syndrome
CRP, Interleukin-6, products of lipid peroxidation
Cognitive Function
时间窗: At 2 months after acute coronary syndrome
Cognitive function test evolution: Montreal Cognitive Assessment Scale
Cognitive Function Anxiety
时间窗: At 2 months after acute coronary syndrome
Cognitive function test evolution: Sheehan Anxiety Rating Scale
Bilirubin
时间窗: At 2 months after acute coronary syndrome
Total and direct
Hepatic enzymes
时间窗: At 2 months after acute coronary syndrome
The levels of AST, ALT, Alkaline phosphatase, Gamma glutamine transferase
Lipid spectrum
时间窗: At 2 months after acute coronary syndrome
Cholesterol, triglycerides, lipoproteins high density, lipoproteins low density
次要结局
未报告次要终点
研究者
Evgeny V. Vyshlov
Principal investigator
Tomsk National Research Medical Center of the Russian Academy of Sciences