Comparison of Anti-Xa Activity of ENOXA ® Versus LOVENOX ® in Acute Coronary Syndrome

Comparison of Anti-Xa Activity in the Treatment With Enoxaparin in ACS Admitted to the Emergency. Randomized Clinical Trial ENOXA ® Versus LOVENOX ®

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01687491

Acronym

AXA

Enrollment

179

Registered

2012-09-19

Start date

2012-07-31

Completion date

2014-10-31

Last updated

2015-11-03

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

Conditions

Acute Coronary Syndrome, Factor X

Keywords

Enoxaparin, Acute Coronary Syndrome, Factor X

Brief summary

This study is a clinical trial monocentric, open, randomized ENOXA ® versus LOVENOX ®, conducted on two parallel groups of patients admitted in emergency for acute coronary syndrome.

Detailed description

The patients included in this study with an acute coronary Syndrome be admitted to the emergency room and receive treatment with enoxaparin. Low molecular weight heparin (LMWH) treatment in this indication is usually spread over a week. The experience of the study intends to focus only on the first injection administered in selected patients. Two assays are carried out, including an assessment of the anti-Xa activity initially before injection of enoxaparin, and 4 hours after administration of the first syringe. Clinical monitoring is intrahospital from the date of hospitalization of patients included until emergency exit (transfer to another service, or return home) Tolerance assessment (clinical and biological) is performed during follow-up.

Interventions

DRUGENOXA®

enoxaparine 100 UI/Kg subcutaneous injection

DRUGLOVENOX®

enoxaparine 100 UI/Kg subcutaneous injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

* Male or female over the age of 20 years * acute coronary syndrome * Admission to the emergency department

Exclusion criteria

* Patient participating in another study * Pregnant or lactating or of childbearing potential not using medically accepted method of contraception * Taking an anticoagulant in the last three months * Patient with known haemostatic disorder * Contraindication absolute and / or relative to the use of enoxaparin * Nobody wishing to participate in this study or not having the ability to understand its objectives

Design outcomes

Primary

Measure	Time frame	Description
anti-Xa activity	4 hours	assay of anti-Xa activity 4 hours after the first injection énoxparine

Secondary

Measure	Time frame	Description
adverse events	participants will be followed for the duration of hospital stay, an expected average of 7 days	Tolerance is assessed by the occurrence of adverse events and / or serious adverse events

Countries

Tunisia

Outcome results

None listed

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