Enoxaparin Bioequivalence Study in Acute Coronary Syndrome Patients

Acute Coronary Syndrome Clinical Trial

— Enoxaparine  

Official title:

Generic and Branded Enoxaparin Bioequivalence: a Randomized Study in Acute Coronary Syndrome Patients With an In-vitro Thrombin Generation Testing Comparison

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04552067
• Other study ID #: Enoxaparine
• Status: Completed
• Phase: Phase 1
• Start date: December 2012
• Est. completion date: January 2014

Study information

• Verified date: September 2020
• Source: University of Monastir
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. completion date: January 2014
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Drug:
• Lovenox
patients given curative dose of Lovenox
• Enoxaparin
patients given curative dose of Enoxa

Locations

Country	Name	City	State
Tunisia	Emergency Department of University Hospital of Monastir	Monastir

Sponsors (2)

Lead Sponsor	Collaborator
University of Monastir	University Hospital Fattouma Bourguiba

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	anti Xa activity (UI/ml)	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	4 hours
Secondary	Major Adverse Cardiac Events	All major cardiovascular events	30 days

External Links

•   official website