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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01687491
First Posted: September 19, 2012
Last Update Posted: November 3, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University Hospital Fattouma Bourguiba
Information provided by (Responsible Party):
Les Laboratoires des Médicaments Stériles
  Purpose
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.

Condition Intervention Phase
Acute Coronary Syndrome Factor X Drug: ENOXA® Drug: LOVENOX® Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Anti-Xa Activity in the Treatment With Enoxaparin in ACS Admitted to the Emergency. Randomized Clinical Trial ENOXA ® Versus LOVENOX ®

Resource links provided by NLM:


Further study details as provided by Les Laboratoires des Médicaments Stériles:

Primary Outcome Measures:
  • anti-Xa activity [ Time Frame: 4 hours ]
    assay of anti-Xa activity 4 hours after the first injection énoxparine


Secondary Outcome Measures:
  • 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


Enrollment: 179
Study Start Date: July 2012
Study Completion Date: October 2014
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01687491


Locations
Tunisia
Departement of Emergency
Monastir, Tunisia, 5000
Sponsors and Collaborators
Les Laboratoires des Médicaments Stériles
University Hospital Fattouma Bourguiba
Investigators
Study Chair: Semir Nouira, PHD Fattouma Bourguiba Hospital, Monastir
Principal Investigator: Mohsen Hassine Fattouma Bourguiba, Monastir
  More Information

Additional Information:
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

Responsible Party: Les Laboratoires des Médicaments Stériles
ClinicalTrials.gov Identifier: NCT01687491     History of Changes
Other Study ID Numbers: AXA_2012
First Submitted: September 11, 2012
First Posted: September 19, 2012
Last Update Posted: November 3, 2015
Last Verified: September 2012

Keywords provided by Les Laboratoires des Médicaments Stériles:
Enoxaparin
Acute Coronary Syndrome
Factor X

Additional relevant MeSH terms:
Syndrome
Acute Coronary Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Heparin, Low-Molecular-Weight
Dalteparin
Enoxaparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action