Comparison of Anti-Xa Activity in the Treatment With Enoxaparin in ACS Admitted to the Emergency. Randomized Clinical Trial ENOXA ® Versus LOVENOX ®
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 179
- 试验地点
- 1
- 主要终点
- anti-Xa activity
研究概览
简要总结
This study is a clinical trial monocentric, open, randomized ENOXA ® versus LOVENOX ®, conducted on two parallel groups of patients admitted in emergency for acute coronary syndrome.
详细描述
The patients included in this study with an acute coronary Syndrome be admitted to the emergency room and receive treatment with enoxaparin. Low molecular weight heparin (LMWH) treatment in this indication is usually spread over a week. The experience of the study intends to focus only on the first injection administered in selected patients.
Two assays are carried out, including an assessment of the anti-Xa activity initially before injection of enoxaparin, and 4 hours after administration of the first syringe.
Clinical monitoring is intrahospital from the date of hospitalization of patients included until emergency exit (transfer to another service, or return home)
Tolerance assessment (clinical and biological) is performed during follow-up.
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 (Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female over the age of 20 years
- •acute coronary syndrome
- •Admission to the emergency department
排除标准
- •Patient participating in another study
- •Pregnant or lactating or of childbearing potential not using medically accepted method of contraception
- •Taking an anticoagulant in the last three months
- •Patient with known haemostatic disorder
- •Contraindication absolute and / or relative to the use of enoxaparin
- •Nobody wishing to participate in this study or not having the ability to understand its objectives
研究组 & 干预措施
Enoxa
ENOXA® Anti-Xa/kg 100 IU by subcutaneous injection every 12 hours
干预措施: ENOXA® (Drug)
Lovenox
LOVENOX® Anti-Xa/kg 100 IU by subcutaneous injection every 12 hours
干预措施: LOVENOX® (Drug)
结局指标
主要结局
anti-Xa activity
时间窗: 4 hours
assay of anti-Xa activity 4 hours after the first injection énoxparine
次要结局
- adverse events(participants will be followed for the duration of hospital stay, an expected average of 7 days)