NCT01687491

Comparison of Anti-Xa Activity of ENOXA ® Versus LOVENOX ® in Acute Coronary Syndrome

Comparison of Anti-Xa Activity in the Treatment With Enoxaparin in ACS Admitted to the Emergency. Randomized Clinical Trial ENOXA ® Versus LOVENOX ®

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 179 (actual)
• Sponsor: Les Laboratoires des Médicaments Stériles · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

This study is a clinical trial monocentric, open, randomized ENOXA ® versus LOVENOX ®, conducted on two parallel groups of patients admitted in emergency for acute coronary syndrome.

Detailed description

The patients included in this study with an acute coronary Syndrome be admitted to the emergency room and receive treatment with enoxaparin. Low molecular weight heparin (LMWH) treatment in this indication is usually spread over a week. The experience of the study intends to focus only on the first injection administered in selected patients. Two assays are carried out, including an assessment of the anti-Xa activity initially before injection of enoxaparin, and 4 hours after administration of the first syringe. Clinical monitoring is intrahospital from the date of hospitalization of patients included until emergency exit (transfer to another service, or return home) Tolerance assessment (clinical and biological) is performed during follow-up.

Conditions

• Acute Coronary Syndrome
• Factor X

Interventions

Type	Name	Description
DRUG	ENOXA®	enoxaparine 100 UI/Kg subcutaneous injection
DRUG	LOVENOX®	enoxaparine 100 UI/Kg subcutaneous injection

Timeline

• Start date: 2012-07-01
• Primary completion: 2013-05-01
• Completion: 2014-10-01
• First posted: 2012-09-19
• Last updated: 2015-11-03

Locations

1 site across 1 country: Tunisia