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Comparison of Anti-Xa Activity of ENOXA ® Versus LOVENOX ® in Acute Coronary Syndrome (AXA)

This study has been completed.
Sponsor:
Collaborator:
University Hospital Fattouma Bourguiba
Information provided by (Responsible Party):
Les Laboratoires des Médicaments Stériles
ClinicalTrials.gov Identifier:
NCT01687491
First received: September 11, 2012
Last updated: October 31, 2014
Last verified: September 2012
  Purpose

This study is a clinical trial monocentric, open, randomized ENOXA ® versus LOVENOX ®, conducted on two parallel groups of patients admitted in emergency for acute coronary syndrome.


Condition Intervention Phase
Acute Coronary Syndrome
Factor X
Drug: ENOXA®
Drug: LOVENOX®
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Anti-Xa Activity in the Treatment With Enoxaparin in ACS Admitted to the Emergency. Randomized Clinical Trial ENOXA ® Versus LOVENOX ®

Resource links provided by NLM:


Further study details as provided by Les Laboratoires des Médicaments Stériles:

Primary Outcome Measures:
  • anti-Xa activity [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
    assay of anti-Xa activity 4 hours after the first injection énoxparine


Secondary Outcome Measures:
  • adverse events [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 7 days ] [ Designated as safety issue: Yes ]
    Tolerance is assessed by the occurrence of adverse events and / or serious adverse events


Enrollment: 179
Study Start Date: July 2012
Study Completion Date: October 2014
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Enoxa
ENOXA® Anti-Xa/kg 100 IU by subcutaneous injection every 12 hours
Drug: ENOXA®
enoxaparine 100 UI/Kg subcutaneous injection
Other Name: ENOXA®
Active Comparator: Lovenox
LOVENOX® Anti-Xa/kg 100 IU by subcutaneous injection every 12 hours
Drug: LOVENOX®
enoxaparine 100 UI/Kg subcutaneous injection
Other Name: LOVENOX®

Detailed Description:

The patients included in this study with an acute coronary Syndrome be admitted to the emergency room and receive treatment with enoxaparin. Low molecular weight heparin (LMWH) treatment in this indication is usually spread over a week. The experience of the study intends to focus only on the first injection administered in selected patients.

Two assays are carried out, including an assessment of the anti-Xa activity initially before injection of enoxaparin, and 4 hours after administration of the first syringe.

Clinical monitoring is intrahospital from the date of hospitalization of patients included until emergency exit (transfer to another service, or return home)

Tolerance assessment (clinical and biological) is performed during follow-up.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female over the age of 20 years
  • acute coronary syndrome
  • Admission to the emergency department

Exclusion Criteria:

  • Patient participating in another study
  • Pregnant or lactating or of childbearing potential not using medically accepted method of contraception
  • Taking an anticoagulant in the last three months
  • Patient with known haemostatic disorder
  • Contraindication absolute and / or relative to the use of enoxaparin
  • Nobody wishing to participate in this study or not having the ability to understand its objectives
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01687491

Locations
Tunisia
Departement of Emergency
Monastir, Tunisia, 5000
Sponsors and Collaborators
Les Laboratoires des Médicaments Stériles
University Hospital Fattouma Bourguiba
Investigators
Study Chair: Semir Nouira, PHD Fattouma Bourguiba Hospital, Monastir
Principal Investigator: Mohsen Hassine Fattouma Bourguiba, Monastir
  More Information

No publications provided

Responsible Party: Les Laboratoires des Médicaments Stériles
ClinicalTrials.gov Identifier: NCT01687491     History of Changes
Other Study ID Numbers: AXA_2012
Study First Received: September 11, 2012
Last Updated: October 31, 2014
Health Authority: Tunisia: Office of Pharmacies and Medicines

Keywords provided by Les Laboratoires des Médicaments Stériles:
Enoxaparin
Acute Coronary Syndrome
Factor X

Additional relevant MeSH terms:
Acute Coronary Syndrome
Syndrome
Angina Pectoris
Cardiovascular Diseases
Chest Pain
Disease
Heart Diseases
Myocardial Ischemia
Pain
Pathologic Processes
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on November 24, 2014