Comparison of Anti-Xa Activity of ENOXA � Versus LOVENOX � in Acute Coronary Syndrome
Information source: Les Laboratoires des Médicaments Stériles
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Coronary Syndrome; Factor X
Intervention: ENOXA® (Drug); LOVENOX® (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Les Laboratoires des Médicaments Stériles Official(s) and/or principal investigator(s): Semir Nouira, PHD, Study Chair, Affiliation: Fattouma Bourguiba Hospital, Monastir Mohsen Hassine, Principal Investigator, Affiliation: Fattouma Bourguiba, Monastir
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.
Clinical Details
Official title: Comparison of Anti-Xa Activity in the Treatment With Enoxaparin in ACS Admitted to the Emergency. Randomized Clinical Trial ENOXA ® Versus LOVENOX ®
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Primary outcome: anti-Xa activity
Secondary outcome: adverse events
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.
Eligibility
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Male or female over the age of 20 years
- acute coronary syndrome
- Admission to the emergency department
Exclusion Criteria:
- Patient participating in another study
- Pregnant or lactating or of childbearing potential not using medically accepted
method of contraception
- Taking an anticoagulant in the last three months
- Patient with known haemostatic disorder
- Contraindication absolute and / or relative to the use of enoxaparin
- Nobody wishing to participate in this study or not having the ability to understand
its objectives
Locations and Contacts
Departement of Emergency, Monastir 5000, Tunisia
Additional Information
Starting date: July 2012
Last updated: October 31, 2014
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