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Enoxamed Study in the Treatment of Acute Coronary Syndromes

Information source: University of Monastir
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Coronary Syndrome

Intervention: LOVENOX (Drug); ENOXAMED (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: University of Monastir

Official(s) and/or principal investigator(s):
Nouira Samir, Professor, Principal Investigator, Affiliation: University hospital of Monastir

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.

Clinical Details

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 design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome: anti Xa activity (UI/ml)

Secondary outcome: adverse events

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 .

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Emergency Department of University Hospital of Monastir, Monastir 5050, Tunisia
Additional Information

official website

Starting date: June 2013
Last updated: December 5, 2014

Page last updated: August 23, 2015

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