Comparison of the Anti Xa Activity in the Enoxaparin for Acute Coronary Syndromes Admitted to the Emergency. Randomized Clinical Trial ENOXAMED Versus LOVENOX
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- anti Xa activity (UI/ml)
研究概览
简要总结
Because of their anti-Xa and ease of administration activity, the Low molecular weight heparin represent an attractive alternative to the unfractionated heparin. Several clinical trials have demonstrated that Low molecular weight heparin was more effective than Unfractionated heparin without increasing bleeding complications. Enoxaparin has been the most studied. Its use is recommended.
Demonstrate that Enoxamed® is comparable to that of Lovenox® in the anti-Xa activity action.
详细描述
Single-center randomized controlled trial, single-blind, including patient with an acute coronary syndrome confirmed, to measure the anti-Xa activity between H0 and H4.the study was done on two groups ; ENOXAMED® group : In this case the patient receives an injection of enoxaparin ( ENOXAMED® ; Unimed Laboratories) intravenously. Curative dose (100 IU/10 kg).
Control group ( LOVENOX ® ) In this case the patient receives LOVENOX intravenous injection curative dose of 100 kg IU/10 .
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
- •Age over 18 year old
- •With an acute coronary syndrome confirmed
排除标准
- •Age less than 18 years
- •Persistent ST- segment elevation
- •Contre indication of enoxaparin and heparin in general.
- •Patient participating in another study,
- •Pregnant or nursing women
- •patients taking an anticoagulant in the last three months,
- •Patients with coagulopathy
研究组 & 干预措施
LOVENOX
patients are given a curative dose of Enoxaparin (LOVENOX)
干预措施: LOVENOX (Drug)
ENOXAMED
patients are given a curative dose of Enoxaparin (ENOXAMED)
干预措施: ENOXAMED (Drug)
结局指标
主要结局
anti Xa activity (UI/ml)
时间窗: at baseline and after 4 hours
Compare the Anticoagulant Activity (measured in a UI per ml in a reference laboratory) of Two Formulations of Enoxaparin \[ENOXAMED ® Versus LOVENOX ®\], Conducted on Two Parallel Groups of Patients Admitted to Emergency for Acute Coronary Syndrome
次要结局
- adverse events(during hospital stay with an average of 5 days)
研究者
Pr. Semir Nouira
Head of departement
University of Monastir