Prospective Randomized Double-center Study of Nonsteroidal Antinflammatory Drug Lornoxicam in Patients With Acute Coronary Syndrome Without Persistent ST- Segment Elevation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- All Cardiovascular events (cardiovascular dearth+nonfatal miocardial infarction+unstable angina)
研究概览
简要总结
The purpose of this study is to determine whether nonsteroidal antiinflammatory drug lornoxicam in combination with low dose aspirin (100mg/day) is effective and safe in patients with Acute Coronary Syndrome without persistent ST-segment elevation.
详细描述
Nonsteroidal Antiinflammatory drugs (NSAIDs) are the most frequently prescribed drugs in the world. There are a lot of controversial information published during recent years about NSAID cardiosafety. It is still unclear do NSAIDs develop cardioprotective or cardiotoxic effects in acute and chronic heart disease patients. Aim of the study was to investigate safety and efficacy of Lornoxicam, nonselective COX-inhibitor, in patients with acute coronary syndrome without ST-segment elevation (NSTEACS) and to evaluate the influence of Lornoxicam on C-reactive protein (CRP) and IL-6, IL-10 levels.
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
- Single (Participant)
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
- •Unstable angina verified during first 48 hours after admitting to the hospital or
- •Acute Miocardial infarction without St-segment elevation verified during first 48 hours after admitting to the hospital
排除标准
- •High risk of bleeding of any location
- •Any kind of acute and active inflammatory process (excluding acute coronary syndrome)
- •Aspirin or NSAID Intolerability
- •No informed consent
- •Acute peptic stomach or duodenum ulcer
- •Acute or chronic renal failure (serum creatinin >300 mmol/l)
- •Acute cerebrovascular bleeding
研究组 & 干预措施
Lornoxicam
Lornoxicam 8mg/day and 12mg/day for 15 days
干预措施: Lornoxicam (Drug)
结局指标
主要结局
All Cardiovascular events (cardiovascular dearth+nonfatal miocardial infarction+unstable angina)
时间窗: six months
次要结局
- Noncardiovascular death, Gastrointestinal bleeding(six months)