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Enoxaparin Bioequivalence Study in Acute Coronary Syndrome Patients (Enoxaparine)

Primary Purpose

Acute Coronary Syndrome

Status
Completed
Phase
Phase 1
Locations
Tunisia
Study Type
Interventional
Intervention
Lovenox
Enoxaparin
Sponsored by
University of Monastir
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring enoxaparin, Lovenox, ani-Xa, acute coronary syndrome, Enoxa

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 (ENOXA)

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 [ENOXA ® Versus LOVENOX ®], Conducted on Two Parallel Groups of Patients Admitted to Emergency for Acute Coronary Syndrome

Secondary Outcome Measures

Major Adverse Cardiac Events
All major cardiovascular events

Full Information

First Posted
February 20, 2020
Last Updated
September 10, 2020
Sponsor
University of Monastir
Collaborators
University Hospital Fattouma Bourguiba
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1. Study Identification

Unique Protocol Identification Number
NCT04552067
Brief Title
Enoxaparin Bioequivalence Study in Acute Coronary Syndrome Patients
Acronym
Enoxaparine
Official Title
Generic and Branded Enoxaparin Bioequivalence: a Randomized Study in Acute Coronary Syndrome Patients With an In-vitro Thrombin Generation Testing Comparison
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
January 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 Enoxa® 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 ; ENOXA® group : In this case the patient is given an injection of enoxaparin ( ENOXA® ; 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, Lovenox, ani-Xa, acute coronary syndrome, Enoxa

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
172 (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 (ENOXA)
Intervention Type
Drug
Intervention Name(s)
Lovenox
Intervention Description
patients given curative dose of Lovenox
Intervention Type
Drug
Intervention Name(s)
Enoxaparin
Other Intervention Name(s)
Enoxamed
Intervention Description
patients given curative dose of Enoxa
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 [ENOXA ® Versus LOVENOX ®], Conducted on Two Parallel Groups of Patients Admitted to Emergency for Acute Coronary Syndrome
Time Frame
4 hours
Secondary Outcome Measure Information:
Title
Major Adverse Cardiac Events
Description
All major cardiovascular events
Time Frame
30 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 Semir, 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
5000
Country
Tunisia

12. IPD Sharing Statement

Links:
URL
http://www.urgencemonastir.com
Description
official website

Learn more about this trial

Enoxaparin Bioequivalence Study in Acute Coronary Syndrome Patients

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