Acute Coronary SyndromePhase 4AXANCT01687491
Comparison of Anti-Xa Activity of ENOXA ® Versus LOVENOX ® in Acute Coronary Syndrome
A Phase 4 study testing ENOXA® and LOVENOX® in people with Acute Coronary Syndrome and Factor X, run by Les Laboratoires des Médicaments Stériles at 1 site in Tunisia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Factor X
- What is being tested?
- ENOXA® and LOVENOX®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 179 participants
- Where
- 1 siteTunisia
- Study dates
- Jul 2012to Oct 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female over the age of 20 years
- acute coronary syndrome
- Admission to the emergency department
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Anti-Xa Activity in the Treatment With Enoxaparin in ACS Admitted to the Emergency. Randomized Clinical Trial ENOXA ® Versus LOVENOX ®
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.
Read the 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.
- Conditions
- Acute Coronary Syndrome, Factor X
- Being tested
- ENOXA®, LOVENOX®
- Keywords
- Enoxaparin, Acute Coronary Syndrome, Factor X
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENOXA®Drug
enoxaparine 100 UI/Kg subcutaneous injection
LOVENOX®Drug
enoxaparine 100 UI/Kg subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Enoxa | Active comparator | ENOXA® Anti-Xa/kg 100 IU by subcutaneous injection every 12 hours Receives: Drug: ENOXA® |
| Lovenox | Active comparator | LOVENOX® Anti-Xa/kg 100 IU by subcutaneous injection every 12 hours Receives: Drug: LOVENOX® |
What is being measured
The primary outcome is the main question the study is designed to answer.
anti-Xa activity
assay of anti-Xa activity 4 hours after the first injection énoxparine
Measured: 4 hours
Secondary outcomes (1)
adverse events
Tolerance is assessed by the occurrence of adverse events and / or serious adverse events
Measured: participants will be followed for the duration of hospital stay, an expected average of 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2012 (estimated)
- Study startJul 2012
- Primary completionMay 2013
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Les Laboratoires des Médicaments Stériles
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Hospital Fattouma Bourguiba
- Responsible party
- Sponsor
- Investigators
- Semir Nouira, PHD, Study chair, Fattouma Bourguiba Hospital, MonastirMohsen Hassine, Principal investigator, Fattouma Bourguiba, Monastir
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01687491
- Sponsor's protocol ID
- AXA_2012
- Acronym
- AXA
- Status last verified
- Sep 2012
- First submitted
- 11 Sep 2012
- Last updated
- 3 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Anti-Xa Activity in the Treatment With Enoxaparin in ACS Admitted to the Emergency. Randomized Clinical Trial ENOXA ® Versus LOVENOX ®
- ClinicalTrials.gov ID
- NCT01687491
- Acronym / sponsor ID
- AXA / AXA_2012
- Conditions
- Acute Coronary Syndrome, Factor X
- Keywords
- Enoxaparin, Acute Coronary Syndrome, Factor X
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Les Laboratoires des Médicaments StérilesIndustry (pharma, biotech, devices)
- Collaborators
- University Hospital Fattouma Bourguiba
- Study start
- Jul 2012
- Primary completion
- May 2013 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 19 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enoxa | Active comparator | Drug: ENOXA®ENOXA® Anti-Xa/kg 100 IU by subcutaneous injection every 12 hours |
| Lovenox | Active comparator | Drug: LOVENOX®LOVENOX® Anti-Xa/kg 100 IU by subcutaneous injection every 12 hours |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female over the age of 20 years
- acute coronary syndrome
- Admission to the emergency department
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ENOXA®enoxaparine 100 UI/Kg subcutaneous injection | Drug | Enoxa |
| LOVENOX®enoxaparine 100 UI/Kg subcutaneous injection | Drug | Lovenox |
Primary outcome
anti-Xa activity
Time frame: 4 hours
assay of anti-Xa activity 4 hours after the first injection énoxparine
1 secondary outcome
adverse events
Time frame: participants will be followed for the duration of hospital stay, an expected average of 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2015.
- BackgroundBoubaker 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
- abstract link posted on the journal's websiteLink provided by the sponsor.
- PDF full text of article published on Journal of Bioequivalence \& Bioavailability (open access)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Semir Nouira, PHD study chair
Fattouma Bourguiba Hospital, Monastir
Mohsen Hassine principal investigator
Fattouma Bourguiba, Monastir
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ENOXA® and LOVENOX® in people with Acute Coronary Syndrome and Factor X, run by Les Laboratoires des Médicaments Stériles at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anti-Xa activity (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01687491, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2015.