Enoxamed Study in the Treatment of Acute Coronary Syndromes

Phase 1

Completed

• Conditions: Acute Coronary Syndrome
• Interventions: Drug: ENOXAMED; Drug: LOVENOX

• Registration Number: NCT02152423
• 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 Enoxamed® 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 ; ENOXAMED® group : In this case the patient receives an injection of enoxaparin ( ENOXAMED® ; 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: 2013-06
• Primary Completion: 2014-01
• Study First Submitted: 2014-05-16
• Study First Submitted QC: 2014-05-28
• Study Completion: 2014-06
• Study First Posted: 2014-06-02
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-20
• Last Update Posted: 2020-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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
ENOXAMED	ENOXAMED	patients are given a curative dose of Enoxaparin (ENOXAMED)
LOVENOX	LOVENOX	patients are given a curative dose of Enoxaparin (LOVENOX)

Primary Outcome Measures

Name	Time	Method
anti Xa activity (UI/ml)	at baseline and after 4 hours	Compare the Anticoagulant Activity (measured in a UI per ml in a reference laboratory) of Two Formulations of Enoxaparin \[ENOXAMED ® Versus LOVENOX ®\], Conducted on Two Parallel Groups of Patients Admitted to Emergency for Acute Coronary Syndrome

Secondary Outcome Measures

Name	Time	Method
adverse events	during hospital stay with an average of 5 days	Evaluate the Clinical and Biological Tolerance of the Study Treatments.

Trial Locations

Locations (1)

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