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

November 2, 2015 updated by: Les Laboratoires des Médicaments Stériles

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

179

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tunisia
      • Monastir, Tunisia, 5000
        • Departement of Emergency

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Enoxa
ENOXA® Anti-Xa/kg 100 IU by subcutaneous injection every 12 hours
Drug: ENOXA®
enoxaparine 100 UI/Kg subcutaneous injection
Active Comparator: Lovenox
LOVENOX® Anti-Xa/kg 100 IU by subcutaneous injection every 12 hours
Drug: LOVENOX®
enoxaparine 100 UI/Kg subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
anti-Xa activity
Time Frame: 4 hours
assay of anti-Xa activity 4 hours after the first injection énoxparine
4 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
participants will be followed for the duration of hospital stay, an expected average of 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Les Laboratoires des Médicaments Stériles

Collaborators

University Hospital Fattouma Bourguiba

Investigators

  • Study Chair: Semir Nouira, PHD, Fattouma Bourguiba Hospital, Monastir
  • Principal Investigator: Mohsen Hassine, Fattouma Bourguiba, Monastir

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Boubaker H MD, Grissa MH MD, Sassi M MD, Chakroun T MD, Beltaief K MD, et al. (2015) Generic and Branded Enoxaparin Bioequivalence: A Clinical and Experimental Study. J Bioequiv Availab 7: 225-228. doi:10.4172/jbb.1000244

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

September 11, 2012

First Submitted That Met QC Criteria

September 18, 2012

First Posted (Estimate)

September 19, 2012

Study Record Updates

Last Update Posted (Estimate)

November 3, 2015

Last Update Submitted That Met QC Criteria

November 2, 2015

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AXA_2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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