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Enoxamed Study in the Treatment of Acute Coronary Syndromes (ENOXAMED)

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ClinicalTrials.gov Identifier: NCT02152423
Recruitment Status : Completed
First Posted : June 2, 2014
Last Update Posted : December 8, 2014
Sponsor:
Collaborator:
University Hospital Fattouma Bourguiba
Information provided by (Responsible Party):
Nouira, University of Monastir

Brief Summary:

Because of their anti-Xa and ease of administration activity, the Low molecular weight heparin represent an attractive alternative to the unfractionated heparin. Several clinical trials have demonstrated that Low molecular weight heparin was more effective than Unfractionated heparin without increasing bleeding complications. Enoxaparin has been the most studied. Its use is recommended.

Demonstrate that Enoxamed® is comparable to that of Lovenox® in the anti-Xa activity action.


Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Drug: LOVENOX Drug: ENOXAMED Phase 1

Detailed Description:

Single-center randomized controlled trial, single-blind, including patient with an acute coronary syndrome confirmed, to measure the anti-Xa activity between H0 and H4.the study was done on two groups ; ENOXAMED® group : In this case the patient receives an injection of enoxaparin ( ENOXAMED® ; Unimed Laboratories) intravenously. Curative dose (100 IU/10 kg).

Control group ( LOVENOX ® ) In this case the patient receives LOVENOX intravenous injection curative dose of 100 kg IU/10 .


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Comparison of the Anti Xa Activity in the Enoxaparin for Acute Coronary Syndromes Admitted to the Emergency. Randomized Clinical Trial ENOXAMED Versus LOVENOX
Study Start Date : June 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
LOVENOX
patients are given a curative dose of Enoxaparin (LOVENOX)
Drug: LOVENOX
Active Comparator: ENOXAMED
patients are given a curative dose of Enoxaparin (ENOXAMED)
Drug: ENOXAMED



Primary Outcome Measures :
  1. anti Xa activity (UI/ml) [ Time Frame: at baseline and after 4 hours ]
    Compare the Anticoagulant Activity (measured in a UI per ml in a reference laboratory) of Two Formulations of Enoxaparin [ENOXAMED ® Versus LOVENOX ®], Conducted on Two Parallel Groups of Patients Admitted to Emergency for Acute Coronary Syndrome


Secondary Outcome Measures :
  1. adverse events [ Time Frame: during hospital stay with an average of 5 days ]
    Evaluate the Clinical and Biological Tolerance of the Study Treatments.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age over 18 year old
  • With an acute coronary syndrome confirmed

Exclusion Criteria:

  • Age less than 18 years
  • Persistent ST- segment elevation
  • Contre indication of enoxaparin and heparin in general.
  • Patient participating in another study,
  • Pregnant or nursing women
  • patients taking an anticoagulant in the last three months,
  • Patients with coagulopathy

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): NCT02152423


Locations
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Tunisia
Emergency Department of University Hospital of Monastir
Monastir, Tunisia, 5050
Sponsors and Collaborators
University of Monastir
University Hospital Fattouma Bourguiba
Investigators
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Principal Investigator: Nouira Samir, Professor University hospital of Monastir

Additional Information:
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Responsible Party: Nouira, Head of departement, University of Monastir
ClinicalTrials.gov Identifier: NCT02152423     History of Changes
Other Study ID Numbers: ENOXAMED
First Posted: June 2, 2014    Key Record Dates
Last Update Posted: December 8, 2014
Last Verified: December 2014
Keywords provided by Nouira, University of Monastir:
enoxaparin
Enoxamed
lovenox
anti Xa
acute coronary syndrome
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Enoxaparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action