Viewing Study NCT01687491



Ignite Creation Date: 2024-05-06 @ 12:53 AM
Last Modification Date: 2024-10-26 @ 10:56 AM
Study NCT ID: NCT01687491
Status: COMPLETED
Last Update Posted: 2015-11-03
First Post: 2012-09-11

Brief Title: Comparison of Anti-Xa Activity of ENOXA Versus LOVENOX in Acute Coronary Syndrome
Sponsor: Les Laboratoires des Médicaments Stériles
Organization: Les Laboratoires des Médicaments Stériles

Study Overview

Official Title: Comparison of Anti-Xa Activity in the Treatment With Enoxaparin in ACS Admitted to the Emergency Randomized Clinical Trial ENOXA Versus LOVENOX
Status: COMPLETED
Status Verified Date: 2012-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: AXA
Brief 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None