Enoxamed Study in the Treatment of Acute Coronary Syndromes
ENOXAMED
Comparison of the Anti Xa Activity in the Enoxaparin for Acute Coronary Syndromes Admitted to the Emergency. Randomized Clinical Trial ENOXAMED Versus LOVENOX
1 other identifier
interventional
50
1 country
1
Brief Summary
Because of their anti-Xa and ease of administration activity, the Low molecular weight heparin represent an attractive alternative to the unfractionated heparin. Several clinical trials have demonstrated that Low molecular weight heparin was more effective than Unfractionated heparin without increasing bleeding complications. Enoxaparin has been the most studied. Its use is recommended. Demonstrate that Enoxamed® is comparable to that of Lovenox® in the anti-Xa activity action.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jun 2013
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
June 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 16, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedFirst Posted
Study publicly available on registry
June 2, 2014
CompletedJuly 22, 2020
July 1, 2020
7 months
May 16, 2014
July 20, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
anti Xa activity (UI/ml)
Compare the Anticoagulant Activity (measured in a UI per ml in a reference laboratory) of Two Formulations of Enoxaparin \[ENOXAMED ® Versus LOVENOX ®\], Conducted on Two Parallel Groups of Patients Admitted to Emergency for Acute Coronary Syndrome
at baseline and after 4 hours
Secondary Outcomes (1)
adverse events
during hospital stay with an average of 5 days
Study Arms (2)
LOVENOX
OTHERpatients are given a curative dose of Enoxaparin (LOVENOX)
ENOXAMED
ACTIVE COMPARATORpatients are given a curative dose of Enoxaparin (ENOXAMED)
Interventions
Eligibility Criteria
You may qualify if:
- Age over 18 year old
- With an acute coronary syndrome confirmed
You may not qualify if:
- Age less than 18 years
- Persistent ST- segment elevation
- Contre indication of enoxaparin and heparin in general.
- Patient participating in another study,
- Pregnant or nursing women
- patients taking an anticoagulant in the last three months,
- Patients with coagulopathy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Monastirlead
- University Hospital Fattouma Bourguibacollaborator
Study Sites (1)
Emergency Department of University Hospital of Monastir
Monastir, 5050, Tunisia
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nouira Samir, Professor
University hospital of Monastir
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of departement
Study Record Dates
First Submitted
May 16, 2014
First Posted
June 2, 2014
Study Start
June 1, 2013
Primary Completion
January 1, 2014
Study Completion
June 1, 2014
Last Updated
July 22, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will share