Comparison of Anti-Xa Activity of ENOXA ® Versus LOVENOX ® in Acute Coronary Syndrome (AXA)
This study is currently recruiting participants.
Verified September 2012 by Les Laboratoires des Médicaments Stériles
Sponsor:
Les Laboratoires des Médicaments Stériles
Collaborators:
emergency department of the hospital Fattouma Bourguiba Monastir
Division of Hematology of the hospital Fattouma Bourguiba Monastir
Information provided by (Responsible Party):
Les Laboratoires des Médicaments Stériles
ClinicalTrials.gov Identifier:
NCT01687491
First received: September 11, 2012
Last updated: September 18, 2012
Last verified: September 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
| Estimated Enrollment: | 37 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | December 2012 |
| Primary Completion Date: | September 2012 (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®
Other Name: ENOXA®
|
|
Active Comparator: Lovenox
LOVENOX® Anti-Xa/kg 100 IU by subcutaneous injection every 12 hours
|
Drug: LOVENOX®
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01687491
Contacts
| Contact: Sémir Nouira, PHD | +216 73 425 265 | semir.nouira@rns.tn |
| Contact: Mohsen Hassine, PHD | +216 98 277 139 | mohsen.hassine@rns.tn |
Locations
| Tunisia | |
| Departement of Emergency | Recruiting |
| Monastir, Tunisia, 5000 | |
| Contact: Semir Nouira, PHD +216 73 425 265 semir.nouira@rns.tn | |
| Contact: Mohsen Hassine +216 98 277 139 mohsen.hassine@rns.tn | |
| Principal Investigator: Semir Nouira, PHD | |
Sponsors and Collaborators
Les Laboratoires des Médicaments Stériles
emergency department of the hospital Fattouma Bourguiba Monastir
Division of Hematology of the hospital Fattouma Bourguiba Monastir
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: | September 18, 2012 |
| 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 Myocardial Ischemia Heart Diseases Cardiovascular Diseases Angina Pectoris Vascular Diseases Chest Pain Pain Signs and Symptoms |
Enoxaparin Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents |
ClinicalTrials.gov processed this record on June 17, 2013