Adaptation Dose of Enoxaparin in Moderate Renal Failure Patients With Acute Coronary Syndrome
Validation of Enoxaparin Dose Adaptation in Patients With Moderate Renal Failure Hospitalized for an Acute Coronary Syndrome, the VALIDE Study
研究概览
详细说明
Included patients will be those hospitalized for an acute coronary syndrome with indication of enoxaparin treatment. A same initial dose of 1 mg/kg will be administrated to all patients. According to creatinine clearance, the next doses (every 12 hours subcutaneously) will be adjusted with a 25% dose reduction if creatinine clearance is comprised between 30 and 50 ml/min. After the fourth dose, the anti-Xa plasma levels (main endpoint) will be measured at peak (between 3 and 5 hours after dose administration). Residual values of antiXa will also be measured before the fifth dose administration (secondary criteria).
The objective is to demonstrate a bio-equivalence of efficacy on the anti-Xa values obtained in patients with moderate rela failure compared with patients with creatinine clearance higher than 50 ml/min.
Thrombotic and bleeding events will be recorded during hospitalisation. 140 per-protocol evaluable consecutive patients will have to be obtained: 70 with creatinine clearance higher than 50 ml/min and 70 patients with creatinin clearance between 30 and 50 ml/min.
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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Besançon、法国、25030
- CHU Jean Minjoz
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Boulogne、法国、92100
- Ambroise Paré Hospital
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Creteil、法国、94010
- Henri Mondor Hospital
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Lagny sur Marne、法国、77400
- Lagny center Hospital
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Paris、法国、75013
- Pitié Salpétrière Hospital
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Paris、法国、75018
- CHU Bichat
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Paris、法国、75475
- Lariboisière Hospital
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Toulouse、法国、31000
- Rangueil hospital
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Essonnes
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Corbeil、Essonnes、法国、91100
- Sud Francilien Hospital center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patients hospitalized for acute coronary syndrome
- Indication of enoxaparin treatment
- Informed consent
Exclusion Criteria:
- Myocardial infarction with ST elevation
- Inclusion later than 12 hours after the first enoxaparin dose administration
- Creatinine clearance lower than 30 ml/min
- History of thrombopenia induced by heparin
- Platelet count lower than 100.000 / mm3
- Age < 18
- Pregnancy
- History of hemorrhagic stroke
- Contra-indication to enoxaparin
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:非随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:1
dose adaptation of Enoxaparine at the renal deficient patients
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A same initial dose of 1 mg/kg will be administrated to all patients.
According to creatinine clearance, the next doses (every 12 hours subcutaneously) will be adjusted with a 25% dose reduction if creatinine clearance is comprised between 30 and 50 ml/min.
|
有源比较器:2
No dose adaptation of Enoxaparine at renal normal patients
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No dose adaptation of Enoxaparine
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研究衡量的是什么?
主要结果指标
结果测量 |
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plasma antiXa levels at peak after the fourth enoxaparine dose administration
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次要结果测量
结果测量 |
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residual plasma antiXa level before the fifth enoxaparine dose administration
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activated thromboplastin time
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thrombotic events
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bleeding events
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合作者和调查者
调查人员
- 学习椅:Imad ABI NASR, MD、Ambroise Paré Hospital
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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