Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 10:55 PM
Study NCT ID:
NCT04552067
Status:
COMPLETED
Last Update Posted:
2020-09-17
First Post:
2020-02-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Enoxaparin Bioequivalence Study in Acute Coronary Syndrome Patients
Sponsor:
University of Monastir
Organization:
Study Overview
Official Title:
Generic and Branded Enoxaparin Bioequivalence: a Randomized Study in Acute Coronary Syndrome Patients With an In-vitro Thrombin Generation Testing Comparison
Status:
COMPLETED
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Enoxaparine
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.
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 .
Control group ( LOVENOX ® ):
In this case the patient receives LOVENOX intravenous injection curative dose of 100 kg IU/10 .
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: