Enoxaparin Bioequivalence Study in Acute Coronary Syndrome Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

172 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2014-01-31

Brief Summary

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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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Detailed Description

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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 .

Conditions

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Acute Coronary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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LOVENOX

patients are given a curative dose of Enoxaparin (LOVENOX)

Group Type OTHER

Lovenox

Intervention Type DRUG

patients given curative dose of Lovenox

Enoxamed

patients are given a curative dose of Enoxaparin (ENOXA)

Group Type ACTIVE_COMPARATOR

Enoxaparin

Intervention Type DRUG

patients given curative dose of Enoxa

Interventions

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Lovenox

patients given curative dose of Lovenox

Intervention Type DRUG

Enoxaparin

patients given curative dose of Enoxa

Intervention Type DRUG

Other Intervention Names

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Enoxamed

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No