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

Phase 4

Completed

• Conditions: Acute Coronary Syndrome; Factor X
• Interventions: Drug: ENOXA®; Drug: LOVENOX®

• Registration Number: NCT01687491
• Lead Sponsor: Les Laboratoires des Médicaments Stériles

Brief Summary

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

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 Timeline

• Study Start: 2012-07
• Status Verified: 2012-09
• Study First Submitted: 2012-09-11
• Study First Submitted QC: 2012-09-18
• Study First Posted: 2012-09-19
• Primary Completion: 2013-05
• Study Completion: 2014-10
• Last Update Submitted: 2015-11-02
• Last Update Posted: 2015-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 179

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enoxa	ENOXA®	ENOXA® Anti-Xa/kg 100 IU by subcutaneous injection every 12 hours
Lovenox	LOVENOX®	LOVENOX® Anti-Xa/kg 100 IU by subcutaneous injection every 12 hours

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
adverse events	participants will be followed for the duration of hospital stay, an expected average of 7 days	Tolerance is assessed by the occurrence of adverse events and / or serious adverse events

Trial Locations

Locations (1)

Departement of Emergency; 🇹🇳 Monastir, Tunisia