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Enoxaparine: Enoxaparin Bioequivalence Study in Acute Coronary Syndrome Patients

Sponsor
University of Monastir (Other)
Overall Status
Completed
CT.gov ID
NCT04552067
Collaborator
University Hospital Fattouma Bourguiba (Other)
172
Enrollment
1
Location
2
Arms
13
Duration (Months)
13.2
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
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 ; ENOXA® group : In this case the patient is given an injection of enoxaparin ( ENOXA® ; 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 .

Study Design

Study Type:
Interventional
Actual Enrollment :
172 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Generic and Branded Enoxaparin Bioequivalence: a Randomized Study in Acute Coronary Syndrome Patients With an In-vitro Thrombin Generation Testing Comparison
Study Start Date :
Dec 1, 2012
Actual Primary Completion Date :
Apr 1, 2013
Actual Study Completion Date :
Jan 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Other: LOVENOX

patients are given a curative dose of Enoxaparin (LOVENOX)

Drug: Lovenox
patients given curative dose of Lovenox
Active Comparator: Enoxamed

patients are given a curative dose of Enoxaparin (ENOXA)

Drug: Enoxaparin
patients given curative dose of Enoxa
Other Names:
  • Enoxamed

    		•

    Outcome Measures

    Primary Outcome Measures

    1. anti Xa activity (UI/ml) [4 hours]

      Compare the Anticoagulant Activity (measured in a UI per ml in a reference laboratory) of Two Formulations of Enoxaparin [ENOXA ® Versus LOVENOX ®], Conducted on Two Parallel Groups of Patients Admitted to Emergency for Acute Coronary Syndrome

    Secondary Outcome Measures

    1. Major Adverse Cardiac Events [30 days]

      All major cardiovascular events

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Emergency Department of University Hospital of Monastir Monastir Tunisia 5000

    Sponsors and Collaborators

    • University of Monastir
    • University Hospital Fattouma Bourguiba

    Investigators

    • Principal Investigator: Nouira Semir, Professor, University hospital of Monastir

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Pr. Semir Nouira, Head of departement, University of Monastir
    ClinicalTrials.gov Identifier:
    NCT04552067
    Other Study ID Numbers:
    • Enoxaparine
    First Posted:
    Sep 17, 2020
    Last Update Posted:
    Sep 17, 2020
    Last Verified:
    Sep 1, 2020
    Keywords provided by Pr. Semir Nouira, Head of departement, University of Monastir
    enoxaparin
    Lovenox
    ani-Xa
    acute coronary syndrome
    Enoxa
    Additional relevant MeSH terms:
    Acute Coronary Syndrome
    Syndrome
    Enoxaparin

    Study Results

    No Results Posted as of Sep 17, 2020