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

Les Laboratoires des Médicaments Stériles

Status and phase

Completed

Phase 4

Conditions

Acute Coronary Syndrome

Factor X

Treatments

Drug: ENOXA®

Drug: LOVENOX®

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01687491

AXA_2012

Details and patient eligibility

About

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.

Full 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.

Enrollment

179 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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