NCT04552067

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 172 (actual)
• Sponsor: University of Monastir · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 .

Conditions

• Acute Coronary Syndrome

Interventions

Type	Name	Description
DRUG	Lovenox	patients given curative dose of Lovenox
DRUG	Enoxaparin	patients given curative dose of Enoxa

Timeline

• Start date: 2012-12-01
• Primary completion: 2013-04-01
• Completion: 2014-01-01
• First posted: 2020-09-17
• Last updated: 2020-09-17

Locations

1 site across 1 country: Tunisia