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NCT02152423 Clinical Trial

Enoxamed Study in the Treatment of Acute Coronary Syndromes

Acute Coronary Syndrome Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02152423
Other study ID # ENOXAMED
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date June 2013
Est. completion date June 2014

Study information
Verified date July 2020
Source University of Monastir
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date June 2014
Est. primary completion date January 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• LOVENOX
LMWH
• ENOXAMED
LMWH

Locations
Country Name City State
Tunisia Emergency Department of University Hospital of Monastir Monastir

Sponsors (2)
Lead Sponsor Collaborator
University of Monastir University Hospital Fattouma Bourguiba

Country where clinical trial is conducted

Tunisia, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 adverse events Evaluate the Clinical and Biological Tolerance of the Study Treatments. during hospital stay with an average of 5 days
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