<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01687491</url>
  </required_header>
  <id_info>
    <org_study_id>AXA_2012</org_study_id>
    <nct_id>NCT01687491</nct_id>
  </id_info>
  <brief_title>Comparison of Anti-Xa Activity of ENOXA ® Versus LOVENOX ® in Acute Coronary Syndrome</brief_title>
  <acronym>AXA</acronym>
  <official_title>Comparison of Anti-Xa Activity in the Treatment With Enoxaparin in ACS Admitted to the Emergency. Randomized Clinical Trial ENOXA ® Versus LOVENOX ®</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Les Laboratoires des Médicaments Stériles</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Hospital Fattouma Bourguiba</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Les Laboratoires des Médicaments Stériles</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a clinical trial monocentric, open, randomized ENOXA ® versus LOVENOX ®,&#xD;
      conducted on two parallel groups of patients admitted in emergency for acute coronary&#xD;
      syndrome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The patients included in this study with an acute coronary Syndrome be admitted to the&#xD;
      emergency room and receive treatment with enoxaparin. Low molecular weight heparin (LMWH)&#xD;
      treatment in this indication is usually spread over a week. The experience of the study&#xD;
      intends to focus only on the first injection administered in selected patients.&#xD;
&#xD;
      Two assays are carried out, including an assessment of the anti-Xa activity initially before&#xD;
      injection of enoxaparin, and 4 hours after administration of the first syringe.&#xD;
&#xD;
      Clinical monitoring is intrahospital from the date of hospitalization of patients included&#xD;
      until emergency exit (transfer to another service, or return home)&#xD;
&#xD;
      Tolerance assessment (clinical and biological) is performed during follow-up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">May 2013</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>anti-Xa activity</measure>
    <time_frame>4 hours</time_frame>
    <description>assay of anti-Xa activity 4 hours after the first injection énoxparine</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>adverse events</measure>
    <time_frame>participants will be followed for the duration of hospital stay, an expected average of 7 days</time_frame>
    <description>Tolerance is assessed by the occurrence of adverse events and / or serious adverse events</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">179</enrollment>
  <condition>Acute Coronary Syndrome</condition>
  <condition>Factor X</condition>
  <arm_group>
    <arm_group_label>Enoxa</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>ENOXA® Anti-Xa/kg 100 IU by subcutaneous injection every 12 hours</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lovenox</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>LOVENOX® Anti-Xa/kg 100 IU by subcutaneous injection every 12 hours</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ENOXA®</intervention_name>
    <description>enoxaparine 100 UI/Kg subcutaneous injection</description>
    <arm_group_label>Enoxa</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LOVENOX®</intervention_name>
    <description>enoxaparine 100 UI/Kg subcutaneous injection</description>
    <arm_group_label>Lovenox</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female over the age of 20 years&#xD;
&#xD;
          -  acute coronary syndrome&#xD;
&#xD;
          -  Admission to the emergency department&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient participating in another study&#xD;
&#xD;
          -  Pregnant or lactating or of childbearing potential not using medically accepted method&#xD;
             of contraception&#xD;
&#xD;
          -  Taking an anticoagulant in the last three months&#xD;
&#xD;
          -  Patient with known haemostatic disorder&#xD;
&#xD;
          -  Contraindication absolute and / or relative to the use of enoxaparin&#xD;
&#xD;
          -  Nobody wishing to participate in this study or not having the ability to understand&#xD;
             its objectives&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Semir Nouira, PHD</last_name>
    <role>Study Chair</role>
    <affiliation>Fattouma Bourguiba Hospital, Monastir</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mohsen Hassine</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fattouma Bourguiba, Monastir</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Departement of Emergency</name>
      <address>
        <city>Monastir</city>
        <zip>5000</zip>
        <country>Tunisia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Tunisia</country>
  </location_countries>
  <link>
    <url>http://www.omicsonline.org/bioequivalence-bioavailability-abstract.php?abstract_id=56339</url>
    <description>abstract link posted on the journal's website</description>
  </link>
  <link>
    <url>http://www.omicsonline.org/open-access/generic-and-branded-enoxaparin-bioequivalence-a-clinical-andexperimental-study-jbb-1000244.pdf</url>
    <description>PDF full text of article published on Journal of Bioequivalence &amp; Bioavailability (open access)</description>
  </link>
  <reference>
    <citation>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</citation>
  </reference>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 11, 2012</study_first_submitted>
  <study_first_submitted_qc>September 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2012</study_first_posted>
  <last_update_submitted>November 2, 2015</last_update_submitted>
  <last_update_submitted_qc>November 2, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 3, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Enoxaparin</keyword>
  <keyword>Acute Coronary Syndrome</keyword>
  <keyword>Factor X</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Coronary Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Enoxaparin</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01687491
org study id: AXA_2012
nct id: NCT01687491
lead sponsor: 
collaborator: 
has dmc: Yes
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: anti-Xa activity
time frame: 4 hours
description: assay of anti-Xa activity 4 hours after the first injection énoxparine
measure: adverse events
time frame: participants will be followed for the duration of hospital stay, an expected average of 7 days
description: Tolerance is assessed by the occurrence of adverse events and / or serious adverse events
arm group label: Enoxa
arm group type: Active Comparator
description: ENOXA® Anti-Xa/kg 100 IU by subcutaneous injection every 12 hours
arm group label: Lovenox
arm group type: Active Comparator
description: LOVENOX® Anti-Xa/kg 100 IU by subcutaneous injection every 12 hours
intervention type: Drug
intervention name: ENOXA®
description: enoxaparine 100 UI/Kg subcutaneous injection
arm group label: Enoxa
intervention type: Drug
intervention name: LOVENOX®
description: enoxaparine 100 UI/Kg subcutaneous injection
arm group label: Lovenox
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Semir Nouira, PHD
role: Study Chair
affiliation: Fattouma Bourguiba Hospital, Monastir
last name: Mohsen Hassine
role: Principal Investigator
affiliation: Fattouma Bourguiba, Monastir
facility: 
country: Tunisia
url: http://www.omicsonline.org/bioequivalence-bioavailability-abstract.php?abstract_id=56339
description: abstract link posted on the journal's website
url: http://www.omicsonline.org/open-access/generic-and-branded-enoxaparin-bioequivalence-a-clinical-andexperimental-study-jbb-1000244.pdf
description: PDF full text of article published on Journal of Bioequivalence & Bioavailability (open access)
citation: 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 type: Sponsor
mesh term: Acute Coronary Syndrome
mesh term: Syndrome
mesh term: Enoxaparin