Enoxaparin Bioequivalence Study in Acute Coronary Syndrome Patients

Study Overview
=================
Brief Summary
-----------------
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 Enoxa® is comparable to that of Lovenox® in the anti-Xa activity action.

Detailed Description
-----------------
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 ; ENOXA® group : In this case the patient is given an injection of enoxaparin ( ENOXA® ; 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 .

Official Title
-----------------
Generic and Branded Enoxaparin Bioequivalence: a Randomized Study in Acute Coronary Syndrome Patients With an In-vitro Thrombin Generation Testing Comparison

Conditions
-----------------
Acute Coronary Syndrome

Intervention / Treatment
-----------------
* Drug: Lovenox
* Drug: Enoxaparin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age over 18 year old With an acute coronary syndrome confirmed Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: LOVENOX<br>patients are given a curative dose of Enoxaparin (LOVENOX) | Drug: Lovenox<br>* patients given curative dose of Lovenox<br>|
| Active Comparator: Enoxamed<br>patients are given a curative dose of Enoxaparin (ENOXA) | Drug: Enoxaparin<br>* patients given curative dose of Enoxa<br>* Other names: Enoxamed;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anti Xa activity (UI/ml) | Compare the Anticoagulant Activity (measured in a UI per ml in a reference laboratory) of Two Formulations of Enoxaparin [ENOXA ® Versus LOVENOX ®], Conducted on Two Parallel Groups of Patients Admitted to Emergency for Acute Coronary Syndrome | 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Cardiac Events | All major cardiovascular events | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
enoxaparin, Lovenox, ani-Xa, acute coronary syndrome, Enoxa