Validation of Enoxaparin Dose Adaptation in Patients With Moderate Renal Failure Hospitalized for an Acute Coronary Syndrome, the VALIDE Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 67
- 试验地点
- 9
- 主要终点
- plasma antiXa levels at peak after the fourth enoxaparine dose administration
研究概览
简要总结
The objective of the VALIDE study is to validate that a 25% dose reduction of enoxaparine in patients with moderate renal failure (creatinine clearance between 30 and 50 ml/min) and hospitalized for an acute coronary syndrome provides at steady state a similar anti Xa level in plasma compared to that obtained in patients without renal failure and receiving the usual dose of 1 mg/kg subcutaneously every 12 hours. 140 per - protocol patients are planned to be included.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients hospitalized for acute coronary syndrome
- •Indication of enoxaparin treatment
- •Informed consent
排除标准
- •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
研究组 & 干预措施
1
dose adaptation of Enoxaparine at the renal deficient patients
干预措施: dose adaptation of Enoxaparin (Drug)
2
No dose adaptation of Enoxaparine at renal normal patients
干预措施: normal injection of Enoxaparine (Drug)
结局指标
主要结局
plasma antiXa levels at peak after the fourth enoxaparine dose administration
次要结局
- residual plasma antiXa level before the fifth enoxaparine dose administration
- activated thromboplastin time
- thrombotic events
- bleeding events