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

Les Laboratoires des Médicaments Stériles179 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

179

Conditions

Acute Coronary Syndrome Factor X

Interventions

ENOXA®DRUG

enoxaparine 100 UI/Kg subcutaneous injection

LOVENOX®DRUG

enoxaparine 100 UI/Kg subcutaneous injection

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (1)

Departement of Emergency

Monastir, Monastir Governorate, Tunisia

Outcomes

Primary Outcomes

anti-Xa activity

assay of anti-Xa activity 4 hours after the first injection énoxparine

Time frame: 4 hours

Secondary Outcomes

adverse events

Tolerance is assessed by the occurrence of adverse events and / or serious adverse events

Time frame: participants will be followed for the duration of hospital stay, an expected average of 7 days

Data from ClinicalTrials.gov

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