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

Condition(s) targeted: Acute Coronary Syndrome; Factor X

Intervention: ENOXA® (Drug); LOVENOX® (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Les Laboratoires des Médicaments Stériles

Official(s) and/or principal investigator(s):
Semir Nouira, PHD, Study Chair, Affiliation: Fattouma Bourguiba Hospital, Monastir
Mohsen Hassine, Principal Investigator, Affiliation: Fattouma Bourguiba, Monastir

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.

Official title: Comparison of Anti-Xa Activity in the Treatment With Enoxaparin in ACS Admitted to the Emergency. Randomized Clinical Trial ENOXA ® Versus LOVENOX ®

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Primary outcome: anti-Xa activity

Secondary outcome: adverse events

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.

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Departement of Emergency, Monastir 5000, Tunisia

Starting date: July 2012
Last updated: October 31, 2014