Comparison of Anti-Xa Activity of ENOXA ® Versus LOVENOX ® in Acute Coronary Syndrome (AXA)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
|Official Title:||Comparison of Anti-Xa Activity in the Treatment With Enoxaparin in ACS Admitted to the Emergency. Randomized Clinical Trial ENOXA ® Versus LOVENOX ®|
- anti-Xa activity [ Time Frame: 4 hours ] [ Designated as safety issue: No ]assay of anti-Xa activity 4 hours after the first injection énoxparine
- adverse events [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 7 days ] [ Designated as safety issue: Yes ]Tolerance is assessed by the occurrence of adverse events and / or serious adverse events
|Study Start Date:||July 2012|
|Estimated Study Completion Date:||December 2012|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
Active Comparator: Enoxa
ENOXA® Anti-Xa/kg 100 IU by subcutaneous injection every 12 hours
Other Name: ENOXA®
Active Comparator: Lovenox
LOVENOX® Anti-Xa/kg 100 IU by subcutaneous injection every 12 hours
Other Name: LOVENOX®
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01687491
|Contact: Sémir Nouira, PHD||+216 73 425 firstname.lastname@example.org|
|Contact: Mohsen Hassine, PHD||+216 98 277 email@example.com|
|Departement of Emergency||Recruiting|
|Monastir, Tunisia, 5000|
|Contact: Semir Nouira, PHD +216 73 425 265 firstname.lastname@example.org|
|Contact: Mohsen Hassine +216 98 277 139 email@example.com|
|Principal Investigator: Semir Nouira, PHD|
|Study Chair:||Semir Nouira, PHD||Fattouma Bourguiba Hospital, Monastir|
|Principal Investigator:||Mohsen Hassine||Fattouma Bourguiba, Monastir|