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

Acute Coronary Syndrome Clinical Trial

— AXA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01687491
• Other study ID #: AXA_2012
• Status: Completed
• Phase: Phase 4
• First received: September 11, 2012
• Last updated: November 2, 2015
• Start date: July 2012
• Est. completion date: October 2014

Study information

• Verified date: September 2012
• Source: Les Laboratoires des Médicaments Stériles
• Contact: n/a
• Is FDA regulated: No
• Health authority: Tunisia: Office of Pharmacies and Medicines
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 179
• Est. completion date: October 2014
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Factor X

Intervention

Drug:
• ENOXA®
enoxaparine 100 UI/Kg subcutaneous injection
• LOVENOX®
enoxaparine 100 UI/Kg subcutaneous injection

Locations

Country	Name	City	State
Tunisia	Departement of Emergency	Monastir

Sponsors (2)

Lead Sponsor	Collaborator
Les Laboratoires des Médicaments Stériles	University Hospital Fattouma Bourguiba

Country where clinical trial is conducted

Tunisia, 

References & Publications (1)

Boubaker H MD, Grissa MH MD, Sassi M MD, Chakroun T MD, Beltaief K MD, et al. (2015) Generic and Branded Enoxaparin Bioequivalence: A Clinical and Experimental Study. J Bioequiv Availab 7: 225-228. doi:10.4172/jbb.1000244

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	anti-Xa activity	assay of anti-Xa activity 4 hours after the first injection énoxparine	4 hours	No
Secondary	adverse events	Tolerance is assessed by the occurrence of adverse events and / or serious adverse events	participants will be followed for the duration of hospital stay, an expected average of 7 days	Yes

External Links

•   abstract link posted on the journal's website
•   PDF full text of article published on Journal of Bioequivalence & Bioavailability (open access)