Acute Coronary Syndrome Clinical Trial
— EnoxaparineOfficial title:
Generic and Branded Enoxaparin Bioequivalence: a Randomized Study in Acute Coronary Syndrome Patients With an In-vitro Thrombin Generation Testing Comparison
Verified date | September 2020 |
Source | University of Monastir |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 172 |
Est. completion date | January 2014 |
Est. primary completion date | April 2013 |
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 |
Country | Name | City | State |
---|---|---|---|
Tunisia | Emergency Department of University Hospital of Monastir | Monastir |
Lead Sponsor | Collaborator |
---|---|
University of Monastir | University Hospital Fattouma Bourguiba |
Tunisia,
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 [ENOXA ® Versus LOVENOX ®], Conducted on Two Parallel Groups of Patients Admitted to Emergency for Acute Coronary Syndrome | 4 hours | |
Secondary | Major Adverse Cardiac Events | All major cardiovascular events | 30 days |
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