Skip to main content
OpenTrials
Completed

NCT Number: NCT01687491

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Coronary Syndrome Cardiovascular Diseases Factor X Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Departement of Emergency

Monastir, Monastir Governorate, 5000, Tunisia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ENOXA®

Drug

enoxaparine 100 UI/Kg subcutaneous injection

LOVENOX®

Drug

enoxaparine 100 UI/Kg subcutaneous injection

Primary outcomes

  1. anti-Xa activity

    Time frame: 4 hours

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

Secondary outcomes

  1. adverse events

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Les Laboratoires des Médicaments Stériles

Industry

Collaborators

  • University Hospital Fattouma Bourguiba

Registry information

Official study title

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

Acronym: AXA

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Sep 19, 2012
Registry last updated
Nov 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.