Back to resultsComparison of Anti-Xa Activity of ENOXA ® Versus LOVENOX ® in Acute Coronary Syndrome (AXA)
Primary Purpose
Acute Coronary Syndrome, Factor X
Status
Completed
Phase
Phase 4
Locations
Tunisia
Study Type
Interventional
Intervention
ENOXA®
LOVENOX®
Sponsored by
About this trial
This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring Enoxaparin, Acute Coronary Syndrome, Factor X
Eligibility 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
Sites / Locations
- Departement of Emergency
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Enoxa
Lovenox
Arm Description
ENOXA® Anti-Xa/kg 100 IU by subcutaneous injection every 12 hours
LOVENOX® Anti-Xa/kg 100 IU by subcutaneous injection every 12 hours
Outcomes
Primary Outcome Measures
anti-Xa activity
assay of anti-Xa activity 4 hours after the first injection énoxparine
Secondary Outcome Measures
adverse events
Tolerance is assessed by the occurrence of adverse events and / or serious adverse events
Full Information
NCT ID
NCT01687491
First Posted
September 11, 2012
Last Updated
November 2, 2015
Sponsor
Les Laboratoires des Médicaments Stériles
Collaborators
University Hospital Fattouma Bourguiba
1. Study Identification
Unique Protocol Identification Number
NCT01687491
Brief Title
Comparison of Anti-Xa Activity of ENOXA ® Versus LOVENOX ® in Acute Coronary Syndrome
Acronym
AXA
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 Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Les Laboratoires des Médicaments Stériles
Collaborators
University Hospital Fattouma Bourguiba
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome, Factor X
Keywords
Enoxaparin, Acute Coronary Syndrome, Factor X
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
179 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Enoxa
Arm Type
Active Comparator
Arm Description
ENOXA® Anti-Xa/kg 100 IU by subcutaneous injection every 12 hours
Arm Title
Lovenox
Arm Type
Active Comparator
Arm Description
LOVENOX® Anti-Xa/kg 100 IU by subcutaneous injection every 12 hours
Intervention Type
Drug
Intervention Name(s)
ENOXA®
Intervention Description
enoxaparine 100 UI/Kg subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
LOVENOX®
Intervention Description
enoxaparine 100 UI/Kg subcutaneous injection
Primary Outcome Measure Information:
Title
anti-Xa activity
Description
assay of anti-Xa activity 4 hours after the first injection énoxparine
Time Frame
4 hours
Secondary Outcome Measure Information:
Title
adverse events
Description
Tolerance is assessed by the occurrence of adverse events and / or serious adverse events
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Semir Nouira, PHD
Organizational Affiliation
Fattouma Bourguiba Hospital, Monastir
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mohsen Hassine
Organizational Affiliation
Fattouma Bourguiba, Monastir
Official's Role
Principal Investigator
Facility Information:
Facility Name
Departement of Emergency
City
Monastir
ZIP/Postal Code
5000
Country
Tunisia
12. IPD Sharing Statement
Citations:
Citation
Boubaker H MD, Grissa MH MD, Sassi M MD, Chakroun T MD, Beltaief K MD, et al. (2015) Generic and Branded Enoxaparin Bioequivalence: A Clinical and Experimental Study. J Bioequiv Availab 7: 225-228. doi:10.4172/jbb.1000244
Results Reference
background
Links:
URL
http://www.omicsonline.org/bioequivalence-bioavailability-abstract.php?abstract_id=56339
Description
abstract link posted on the journal's website
URL
http://www.omicsonline.org/open-access/generic-and-branded-enoxaparin-bioequivalence-a-clinical-andexperimental-study-jbb-1000244.pdf
Description
PDF full text of article published on Journal of Bioequivalence & Bioavailability (open access)
Learn more about this trial
Comparison of Anti-Xa Activity of ENOXA ® Versus LOVENOX ® in Acute Coronary Syndrome
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