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NCT Number: NCT04552067

Enoxaparin Bioequivalence Study in Acute Coronary Syndrome Patients

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.

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Key information

Conditions

Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Emergency Department of University Hospital of Monastir

Monastir, 5000, Tunisia

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lovenox

Drug

patients given curative dose of Lovenox

Enoxaparin

Drug

patients given curative dose of Enoxa

Other names: Enoxamed

Primary outcomes

  1. 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

Secondary outcomes

  1. Major Adverse Cardiac Events

    Time frame: 30 days

    All major cardiovascular events

Sponsors and collaborators

Lead sponsor

University of Monastir

Other

Collaborators

  • University Hospital Fattouma Bourguiba

Registry information

Official study title

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

Acronym: Enoxaparine

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Sep 17, 2020
Registry last updated
Sep 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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