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

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ClinicalTrials.gov Identifier: NCT01687491
Recruitment Status : Completed
First Posted : September 19, 2012
Last Update Posted : November 3, 2015
Sponsor:
Collaborator:
University Hospital Fattouma Bourguiba
Information provided by (Responsible Party):
Les Laboratoires des Médicaments Stériles

Tracking Information
First Submitted Date  ICMJE September 11, 2012
First Posted Date  ICMJE September 19, 2012
Last Update Posted Date November 3, 2015
Study Start Date  ICMJE July 2012
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 18, 2012)
anti-Xa activity [ Time Frame: 4 hours ]
assay of anti-Xa activity 4 hours after the first injection énoxparine
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01687491 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 18, 2012)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Anti-Xa Activity of ENOXA ® Versus LOVENOX ® in Acute Coronary Syndrome
Official Title  ICMJE Comparison of Anti-Xa Activity in the Treatment With Enoxaparin in ACS Admitted to the Emergency. Randomized Clinical Trial ENOXA ® Versus LOVENOX ®
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Acute Coronary Syndrome
  • Factor X
Intervention  ICMJE
  • Drug: ENOXA®
    enoxaparine 100 UI/Kg subcutaneous injection
  • Drug: LOVENOX®
    enoxaparine 100 UI/Kg subcutaneous injection
Study Arms  ICMJE
  • Active Comparator: Enoxa
    ENOXA® Anti-Xa/kg 100 IU by subcutaneous injection every 12 hours
    Intervention: Drug: ENOXA®
  • Active Comparator: Lovenox
    LOVENOX® Anti-Xa/kg 100 IU by subcutaneous injection every 12 hours
    Intervention: Drug: LOVENOX®
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 31, 2014)
179
Original Estimated Enrollment  ICMJE
 (submitted: September 18, 2012)
37
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Tunisia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01687491
Other Study ID Numbers  ICMJE AXA_2012
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Les Laboratoires des Médicaments Stériles
Study Sponsor  ICMJE Les Laboratoires des Médicaments Stériles
Collaborators  ICMJE University Hospital Fattouma Bourguiba
Investigators  ICMJE
Study Chair: Semir Nouira, PHD Fattouma Bourguiba Hospital, Monastir
Principal Investigator: Mohsen Hassine Fattouma Bourguiba, Monastir
PRS Account Les Laboratoires des Médicaments Stériles
Verification Date September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP