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| Name | Class |
|---|---|
| University Hospital Fattouma Bourguiba | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enoxa | Active Comparator | ENOXA® Anti-Xa/kg 100 IU by subcutaneous injection every 12 hours |
|
| Lovenox | Active Comparator | LOVENOX® Anti-Xa/kg 100 IU by subcutaneous injection every 12 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ENOXA® | Drug | enoxaparine 100 UI/Kg subcutaneous injection |
| |
| LOVENOX® |
| Measure | Description | Time Frame |
|---|---|---|
| anti-Xa activity | assay of anti-Xa activity 4 hours after the first injection énoxparine | 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| adverse events | Tolerance is assessed by the occurrence of adverse events and / or serious adverse events | participants will be followed for the duration of hospital stay, an expected average of 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Semir Nouira, PHD | Fattouma Bourguiba Hospital, Monastir | Study Chair |
| Mohsen Hassine | Fattouma Bourguiba, Monastir | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Departement of Emergency | Monastir | Monastir Governorate | 5000 | Tunisia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Boubaker H MD, Grissa MH MD, Sassi M MD, Chakroun T MD, Beltaief K MD, et al. (2015) Generic and Branded Enoxaparin Bioequivalence: A Clinical and Experimental Study. J Bioequiv Availab 7: 225-228. doi:10.4172/jbb.1000244 |
| Label | URL |
|---|---|
| abstract link posted on the journal's website | View source |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D017984 | Enoxaparin |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
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| Drug |
enoxaparine 100 UI/Kg subcutaneous injection |
|
| PDF full text of article published on Journal of Bioequivalence \& Bioavailability (open access) | View source |
| D002241 |
| Carbohydrates |