Comparison of Anti-Xa Activity of ENOXA ® Versus LOVENOX ® in Acute Coronary Syndrome

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparison of Anti-Xa Activity in the Treatment With Enoxaparin in ACS Admitted to the Emergency. Randomized Clinical Trial ENOXA ® Versus LOVENOX ®

Conditions
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Acute Coronary Syndrome, Factor X

Intervention / Treatment
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* Drug: ENOXA®
* Drug: LOVENOX®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female over the age of 20 years acute coronary syndrome Admission to the emergency department Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Enoxa<br>ENOXA® Anti-Xa/kg 100 IU by subcutaneous injection every 12 hours | Drug: ENOXA®<br>* enoxaparine 100 UI/Kg subcutaneous injection<br>|
| Active Comparator: Lovenox<br>LOVENOX® Anti-Xa/kg 100 IU by subcutaneous injection every 12 hours | Drug: LOVENOX®<br>* enoxaparine 100 UI/Kg subcutaneous injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anti-Xa activity | assay of anti-Xa activity 4 hours after the first injection énoxparine | 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse events | Tolerance is assessed by the occurrence of adverse events and / or serious adverse events | participants will be followed for the duration of hospital stay, an expected average of 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Enoxaparin, Acute Coronary Syndrome, Factor X