Back to resultsEnoxamed Study in the Treatment of Acute Coronary Syndromes (ENOXAMED)
Primary Purpose
Acute Coronary Syndrome
Status
Completed
Phase
Phase 1
Locations
Tunisia
Study Type
Interventional
Intervention
LOVENOX
ENOXAMED
Sponsored by
About this trial
This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring enoxaparin, Enoxamed, lovenox, anti Xa, acute coronary syndrome
Eligibility Criteria
Inclusion Criteria:
- Age over 18 year old
- With an acute coronary syndrome confirmed
Exclusion Criteria:
- 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
Sites / Locations
- Emergency Department of University Hospital of Monastir
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Active Comparator
Arm Label
LOVENOX
ENOXAMED
Arm Description
patients are given a curative dose of Enoxaparin (LOVENOX)
patients are given a curative dose of Enoxaparin (ENOXAMED)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
adverse events
Evaluate the Clinical and Biological Tolerance of the Study Treatments.
Full Information
NCT ID
NCT02152423
First Posted
May 16, 2014
Last Updated
July 20, 2020
Sponsor
University of Monastir
Collaborators
University Hospital Fattouma Bourguiba
1. Study Identification
Unique Protocol Identification Number
NCT02152423
Brief Title
Enoxamed Study in the Treatment of Acute Coronary Syndromes
Acronym
ENOXAMED
Official Title
Comparison of the Anti Xa Activity in the Enoxaparin for Acute Coronary Syndromes Admitted to the Emergency. Randomized Clinical Trial ENOXAMED Versus LOVENOX
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Monastir
Collaborators
University Hospital Fattouma Bourguiba
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Single-center randomized controlled trial, single-blind, including patient with an acute coronary syndrome confirmed, to measure the anti-Xa activity between H0 and H4.the study was done on two groups ; ENOXAMED® group : In this case the patient receives an injection of enoxaparin ( ENOXAMED® ; Unimed Laboratories) intravenously. Curative dose (100 IU/10 kg).
Control group ( LOVENOX ® ) In this case the patient receives LOVENOX intravenous injection curative dose of 100 kg IU/10 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome
Keywords
enoxaparin, Enoxamed, lovenox, anti Xa, acute coronary syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LOVENOX
Arm Type
Other
Arm Description
patients are given a curative dose of Enoxaparin (LOVENOX)
Arm Title
ENOXAMED
Arm Type
Active Comparator
Arm Description
patients are given a curative dose of Enoxaparin (ENOXAMED)
Intervention Type
Drug
Intervention Name(s)
LOVENOX
Intervention Description
LMWH
Intervention Type
Drug
Intervention Name(s)
ENOXAMED
Intervention Description
LMWH
Primary Outcome Measure Information:
Title
anti Xa activity (UI/ml)
Description
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
Time Frame
at baseline and after 4 hours
Secondary Outcome Measure Information:
Title
adverse events
Description
Evaluate the Clinical and Biological Tolerance of the Study Treatments.
Time Frame
during hospital stay with an average of 5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age over 18 year old
With an acute coronary syndrome confirmed
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nouira Samir, Professor
Organizational Affiliation
University hospital of Monastir
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emergency Department of University Hospital of Monastir
City
Monastir
ZIP/Postal Code
5050
Country
Tunisia
12. IPD Sharing Statement
Plan to Share IPD
Yes
Links:
URL
http://www.urgencemonastir.com
Description
official website
Learn more about this trial
Enoxamed Study in the Treatment of Acute Coronary Syndromes
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