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ENOXAMED: Enoxamed Study in the Treatment of Acute Coronary Syndromes

Sponsor
University of Monastir (Other)
Overall Status
Completed
CT.gov ID
NCT02152423
Collaborator
University Hospital Fattouma Bourguiba (Other)
50
Enrollment
1
Location
2
Arms
12
Duration (Months)
4.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

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 .

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
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 Start Date :
Jun 1, 2013
Actual Primary Completion Date :
Jan 1, 2014
Actual Study Completion Date :
Jun 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Other: LOVENOX

patients are given a curative dose of Enoxaparin (LOVENOX)

Drug: LOVENOX
LMWH
Active Comparator: ENOXAMED

patients are given a curative dose of Enoxaparin (ENOXAMED)

Drug: ENOXAMED
LMWH

Outcome Measures

Primary Outcome Measures

  1. anti Xa activity (UI/ml) [at baseline and after 4 hours]

    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

  1. adverse events [during hospital stay with an average of 5 days]

    Evaluate the Clinical and Biological Tolerance of the Study Treatments.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Emergency Department of University Hospital of Monastir Monastir Tunisia 5050

Sponsors and Collaborators

  • University of Monastir
  • University Hospital Fattouma Bourguiba

Investigators

  • Principal Investigator: Nouira Samir, Professor, University hospital of Monastir

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Pr. Semir Nouira, Head of departement, University of Monastir
ClinicalTrials.gov Identifier:
NCT02152423
Other Study ID Numbers:
  • ENOXAMED
First Posted:
Jun 2, 2014
Last Update Posted:
Jul 22, 2020
Last Verified:
Jul 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by Pr. Semir Nouira, Head of departement, University of Monastir
enoxaparin
Enoxamed
lovenox
anti Xa
acute coronary syndrome
Additional relevant MeSH terms:
Acute Coronary Syndrome
Syndrome
Enoxaparin

Study Results

No Results Posted as of Jul 22, 2020