Comparison of Anti-Xa Activity of ENOXA ® Versus LOVENOX ® in Acute Coronary Syndrome
AXA
1 other identifier
interventional
179
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jul 2012
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 11, 2012
CompletedFirst Posted
Study publicly available on registry
September 19, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedNovember 3, 2015
September 1, 2012
10 months
September 11, 2012
November 2, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
anti-Xa activity
assay of anti-Xa activity 4 hours after the first injection énoxparine
4 hours
Secondary Outcomes (1)
adverse events
participants will be followed for the duration of hospital stay, an expected average of 7 days
Study Arms (2)
Enoxa
ACTIVE COMPARATORENOXA® Anti-Xa/kg 100 IU by subcutaneous injection every 12 hours
Lovenox
ACTIVE COMPARATORLOVENOX® Anti-Xa/kg 100 IU by subcutaneous injection every 12 hours
Interventions
Eligibility Criteria
You may qualify if:
- Male or female over the age of 20 years
- acute coronary syndrome
- Admission to the emergency department
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Departement of Emergency
Monastir, Monastir Governorate, 5000, Tunisia
Related Publications (1)
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
BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Semir Nouira, PHD
Fattouma Bourguiba Hospital, Monastir
- PRINCIPAL INVESTIGATOR
Mohsen Hassine
Fattouma Bourguiba, Monastir
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 11, 2012
First Posted
September 19, 2012
Study Start
July 1, 2012
Primary Completion
May 1, 2013
Study Completion
October 1, 2014
Last Updated
November 3, 2015
Record last verified: 2012-09