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

Sponsors

Lead Sponsor: University of Monastir

Collaborator: University Hospital Fattouma Bourguiba

Source 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 .

Overall Status Completed
Start Date December 2012
Completion Date January 2014
Primary Completion Date April 2013
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
anti Xa activity (UI/ml) 4 hours
Secondary Outcome
Measure Time Frame
Major Adverse Cardiac Events 30 days
Enrollment 172
Condition
Intervention

Intervention Type: Drug

Intervention Name: Lovenox

Description: patients given curative dose of Lovenox

Arm Group Label: LOVENOX

Intervention Type: Drug

Intervention Name: Enoxaparin

Description: patients given curative dose of Enoxa

Arm Group Label: Enoxamed

Other Name: Enoxamed

Eligibility

Criteria:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Nouira Semir, Professor Principal Investigator University hospital of Monastir
Location
Facility: Emergency Department of University Hospital of Monastir
Location Countries

Tunisia

Verification Date

September 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of Monastir

Investigator Full Name: Pr. Semir Nouira

Investigator Title: Head of departement

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: LOVENOX

Type: Other

Description: patients are given a curative dose of Enoxaparin (LOVENOX)

Label: Enoxamed

Type: Active Comparator

Description: patients are given a curative dose of Enoxaparin (ENOXA)

Acronym Enoxaparine
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Single (Participant)

Source: ClinicalTrials.gov