Enoxaparin Bioequivalence Study in Acute Coronary Syndrome Patients (Enoxaparine)

University of Monastir

Status and phase: Completed; Phase 1

Conditions: Acute Coronary Syndrome

Treatments: Drug: Lovenox; Drug: Enoxaparin

Study type: Interventional

Funder types: Other

Identifiers

NCT04552067

Enoxaparine

Details and patient eligibility

About

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.

Full 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 .

Enrollment: 172 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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172 participants in 2 patient groups

LOVENOX

Other group

Description:

patients are given a curative dose of Enoxaparin (LOVENOX)

Treatment:

Drug: Lovenox

Enoxamed

Active Comparator group

Description:

patients are given a curative dose of Enoxaparin (ENOXA)

Treatment:

Drug: Enoxaparin