Acute Coronary SyndromePhase 1EnoxaparineNCT04552067
Enoxaparin Bioequivalence Study in Acute Coronary Syndrome Patients
A Phase 1 study testing Lovenox and Enoxaparin in people with Acute Coronary Syndrome, run by University of Monastir at 1 site in Tunisia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Lovenox and Enoxaparin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteTunisia
- Study dates
- Dec 2012to Jan 2014
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 18 year old
- With an acute coronary syndrome confirmed
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Tunisia1 site
Emergency Department of University Hospital of Monastir
Monastir, 5000
About this study
Official title: Generic and Branded Enoxaparin Bioequivalence: a Randomized Study in Acute Coronary Syndrome Patients With an In-vitro Thrombin Generation Testing Comparison
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.
Read the 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 .
- Conditions
- Acute Coronary Syndrome
- Being tested
- Lovenox, Enoxaparin
- Keywords
- enoxaparin, Lovenox, ani-Xa, acute coronary syndrome, Enoxa
- 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.
LovenoxDrug
patients given curative dose of Lovenox
EnoxaparinDrug
Also called Enoxamed
patients given curative dose of Enoxa
| Study group | Role | What they receive |
|---|---|---|
| LOVENOX | Other | patients are given a curative dose of Enoxaparin (LOVENOX) Receives: Drug: Lovenox |
| Enoxamed | Active comparator | patients are given a curative dose of Enoxaparin (ENOXA) Receives: Drug: Enoxaparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 hours
Secondary outcomes (1)
Major Adverse Cardiac Events
All major cardiovascular events
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2020
- Study startDec 2012
- Primary completionApr 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Monastir
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Fattouma Bourguiba
- Responsible party
- Principal investigator, Pr. Semir Nouira, University of Monastir
- Investigators
- Nouira Semir, Professor, Principal investigator, University hospital of Monastir
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04552067
- Sponsor's protocol ID
- Enoxaparine
- Acronym
- Enoxaparine
- Status last verified
- Sep 2020
- First submitted
- 20 Feb 2020
- Last updated
- 17 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Generic and Branded Enoxaparin Bioequivalence: a Randomized Study in Acute Coronary Syndrome Patients With an In-vitro Thrombin Generation Testing Comparison
- ClinicalTrials.gov ID
- NCT04552067
- Acronym / sponsor ID
- Enoxaparine / Enoxaparine
- Conditions
- Acute Coronary Syndrome
- Keywords
- enoxaparin, Lovenox, ani-Xa, acute coronary syndrome, Enoxa
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- University of MonastirUniversity, hospital or other
- Collaborators
- University Hospital Fattouma Bourguiba
- Study start
- Dec 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 17 Sep 2020 (actual)
- 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.
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.
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LOVENOX | Other | Drug: Lovenoxpatients are given a curative dose of Enoxaparin (LOVENOX) |
| Enoxamed | Active comparator | Drug: Enoxaparinpatients are given a curative dose of Enoxaparin (ENOXA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age over 18 year old
- With an acute coronary syndrome confirmed
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Lovenoxpatients given curative dose of Lovenox | Drug | LOVENOX |
| EnoxaparinAlso: Enoxamedpatients given curative dose of Enoxa | Drug | Enoxamed |
Primary outcome
anti Xa activity (UI/ml)
Time frame: 4 hours
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
1 secondary outcome
Major Adverse Cardiac Events
Time frame: 30 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 17 Sep 2020.
- official websiteLink 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.
Nouira Semir, Professor principal investigator
University hospital of Monastir
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lovenox and Enoxaparin in people with Acute Coronary Syndrome, run by University of Monastir 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 2 inclusion and 7 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 17 Sep 2020. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 (UI/ml) (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Sep 2020.