NCT00296218已完成3 期
Randomized Comparison of a Two-month Regimen of Irbesartan Versus Enalapril on Cardiovascular Markers in Patients With Acute Coronary Syndrome Without ST Segment Elevation.
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 440
- 试验地点
- 11
- 主要终点
- comparison of the relative change from baseline in hsCRP at day 60 between the two treatment groups
研究概览
简要总结
Primary Objective
- The main objective of this study is to assess if a two-month regimen of irbesartan in patients hospitalized for acute coronary syndrome without ST segment elevation can reduce inflammation markers (ie hsCRP), in comparison to a similar regimen of enalapril.
Secondary Objectives
- To compare both regimens on several other biological parameters which have demonstrated their relevance and their predictive clinical value (ie BNP, microalbuminuria, troponin I ...) in this patient population.
- To compare on the above parameters the early initiation of treatment versus the initiation of treatment at hospital discharge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
comparison of the relative change from baseline in hsCRP at day 60 between the two treatment groups
次要结局
- Relative change from baseline of hsCRP at discharge
- Changes from baseline in BNP and Microalbuminuria (MAU) at discharge and day 60
- Change of Troponin I from baseline at discharge
- In addition at baseline, discharge and D60 the following parameters will be evaluated and their evolution compared in the two treatment groups: IL6, CD 40 L, sPLA2 and Lp-PLA2, IMA, MMP-9, MPO (myeloperoxydase), aldosterone
- Blood pressure at discharge, D15 and D60.
- The early versus late (at hospital discharge) initiation of treatment will also be evaluated on the above-listed parameters.
- & Safety outcomes
研究者
研究点 (11)
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