Enoxaparin Bioequivalence Study in Acute Coronary Syndrome Patients

Phase 1

Completed

• Conditions: Acute Coronary Syndrome
• Interventions: Drug: Lovenox; Drug: Enoxaparin

• Registration Number: NCT04552067
• Lead Sponsor: University of Monastir

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 .

Study Timeline

• Study Start: 2012-12
• Primary Completion: 2013-04
• Study Completion: 2014-01
• Study First Submitted: 2020-02-20
• Status Verified: 2020-09
• Study First Submitted QC: 2020-09-10
• Last Update Submitted: 2020-09-10
• Study First Posted: 2020-09-17
• Last Update Posted: 2020-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 172

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LOVENOX	Lovenox	patients are given a curative dose of Enoxaparin (LOVENOX)
Enoxamed	Enoxaparin	patients are given a curative dose of Enoxaparin (ENOXA)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Major Adverse Cardiac Events	30 days	All major cardiovascular events

Trial Locations

Locations (1)

Emergency Department of University Hospital of Monastir; 🇹🇳 Monastir, Tunisia