Enoxamed Study in the Treatment of Acute Coronary Syndromes (ENOXAMED)
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|ClinicalTrials.gov Identifier: NCT02152423|
Recruitment Status : Completed
First Posted : June 2, 2014
Last Update Posted : December 8, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Acute Coronary Syndrome||Drug: LOVENOX Drug: ENOXAMED||Phase 1|
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 .
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Comparison of the Anti Xa Activity in the Enoxaparin for Acute Coronary Syndromes Admitted to the Emergency. Randomized Clinical Trial ENOXAMED Versus LOVENOX|
|Study Start Date :||June 2013|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||June 2014|
patients are given a curative dose of Enoxaparin (LOVENOX)
Active Comparator: ENOXAMED
patients are given a curative dose of Enoxaparin (ENOXAMED)
- anti Xa activity (UI/ml) [ Time Frame: 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
- adverse events [ Time Frame: during hospital stay with an average of 5 days ]Evaluate the Clinical and Biological Tolerance of the Study Treatments.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02152423
|Emergency Department of University Hospital of Monastir|
|Monastir, Tunisia, 5050|
|Principal Investigator:||Nouira Samir, Professor||University hospital of Monastir|