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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

179 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2014-10-31

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.

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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.

Conditions

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Acute Coronary Syndrome Factor X

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Enoxa

ENOXA® Anti-Xa/kg 100 IU by subcutaneous injection every 12 hours

Group Type ACTIVE_COMPARATOR

ENOXA®

Intervention Type DRUG

enoxaparine 100 UI/Kg subcutaneous injection

Lovenox

LOVENOX® Anti-Xa/kg 100 IU by subcutaneous injection every 12 hours

Group Type ACTIVE_COMPARATOR

LOVENOX®

Intervention Type DRUG

enoxaparine 100 UI/Kg subcutaneous injection

Interventions

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ENOXA®

enoxaparine 100 UI/Kg subcutaneous injection

Intervention Type DRUG

LOVENOX®

enoxaparine 100 UI/Kg subcutaneous injection

Intervention Type DRUG

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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No