Enoxaparin Bioequivalence Study in Acute Coronary Syndrome Patients (Enoxaparine)

September 10, 2020 updated by: Pr. Semir Nouira, University of Monastir

Generic and Branded Enoxaparin Bioequivalence: a Randomized Study in Acute Coronary Syndrome Patients With an In-vitro Thrombin Generation Testing Comparison

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

172

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tunisia
      • Monastir, Tunisia, 5000
        • Emergency Department of University Hospital of Monastir

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
anti Xa activity (UI/ml)
Time Frame: 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
4 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major Adverse Cardiac Events
Time Frame: 30 days
All major cardiovascular events
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Monastir

Collaborators

University Hospital Fattouma Bourguiba

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

February 20, 2020

First Submitted That Met QC Criteria

September 10, 2020

First Posted (Actual)

September 17, 2020

Study Record Updates

Last Update Posted (Actual)

September 17, 2020

Last Update Submitted That Met QC Criteria

September 10, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Enoxaparine

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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