Enoxaparin Bioequivalence Study in Acute Coronary Syndrome Patients

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04552067

Acronym

Enoxaparine

Enrollment

172

Registered

2020-09-17

Start date

2012-12-31

Completion date

2014-01-31

Last updated

2020-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome

Keywords

enoxaparin, Lovenox, ani-Xa, acute coronary syndrome, Enoxa

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.

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 .

Interventions

DRUGLovenox

patients given curative dose of Lovenox

DRUGEnoxaparin

patients given curative dose of Enoxa

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Major Adverse Cardiac Events	30 days	All major cardiovascular events

Countries

Tunisia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026