Acute Coronary SyndromePhase 4NCT00412802
Adaptation Dose of Enoxaparin in Moderate Renal Failure Patients With Acute Coronary Syndrome
A Phase 4 study testing dose adaptation of Enoxaparin and normal injection of Enoxaparine in people with Acute Coronary Syndrome and Renal Failure, run by French Cardiology Society at 9 sites in France.
Trial summary
The objective of the VALIDE study is to validate that a 25% dose reduction of enoxaparine in patients with moderate renal failure (creatinine clearance between 30 and 50 ml/min) and hospitalized for an acute coronary syndrome provides at steady state a similar anti Xa level in plasma compared to that obtained in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Renal Failure
- What is being tested?
- dose adaptation of Enoxaparin and normal injection of Enoxaparine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 9 sitesFrance
- Study dates
- Dec 2006to Mar 2009
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients hospitalized for acute coronary syndrome
- Indication of enoxaparin treatment
- Informed consent
Who cannot join
- Myocardial infarction with ST elevation
- Inclusion later than 12 hours after the first enoxaparin dose administration
- Creatinine clearance lower than 30 ml/min
- History of thrombopenia induced by heparin
- Platelet count lower than 100.000 / mm3
- Age < 18
Show all 9Show fewer
- Pregnancy
- History of hemorrhagic stroke
- Contra-indication to enoxaparin
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
CHU Jean MINJOZ
Besançon, 25030
Ambroise Paré Hospital
Boulogne, 92100
Sud Francilien Hospital center
Corbeil, Essonnes, 91100
Henri Mondor Hospital
Créteil, 94010
Lagny center Hospital
Lagny-sur-Marne, 77400
Pitié Salpêtrière Hospital
Paris, 75013
CHU Bichat
Paris, 75018
Lariboisiére Hospital
Paris, 75475
Rangueil Hospital
Toulouse, 31000
About this study
Official title: Validation of Enoxaparin Dose Adaptation in Patients With Moderate Renal Failure Hospitalized for an Acute Coronary Syndrome, the VALIDE Study
The objective of the VALIDE study is to validate that a 25% dose reduction of enoxaparine in patients with moderate renal failure (creatinine clearance between 30 and 50 ml/min) and hospitalized for an acute coronary syndrome provides at steady state a similar anti Xa level in plasma compared to that obtained in patients without renal failure and receiving the usual dose of 1 mg/kg subcutaneously every 12 hours. 140 per - protocol patients are planned to be included.
Read the detailed description
Included patients will be those hospitalized for an acute coronary syndrome with indication of enoxaparin treatment. A same initial dose of 1 mg/kg will be administrated to all patients. According to creatinine clearance, the next doses (every 12 hours subcutaneously) will be adjusted with a 25% dose reduction if creatinine clearance is comprised between 30 and 50 ml/min. After the fourth dose, the anti-Xa plasma levels (main endpoint) will be measured at peak (between 3 and 5 hours after dose administration). Residual values of antiXa will also be measured before the fifth dose administration (secondary criteria).
The objective is to demonstrate a bio-equivalence of efficacy on the anti-Xa values obtained in patients with moderate rela failure compared with patients with creatinine clearance higher than 50 ml/min.
Thrombotic and bleeding events will be recorded during hospitalisation. 140 per-protocol evaluable consecutive patients will have to be obtained: 70 with creatinine clearance higher than 50 ml/min and 70 patients with creatinin clearance between 30 and 50 ml/min.
- Conditions
- Acute Coronary Syndrome, Renal Failure
- Being tested
- dose adaptation of Enoxaparin, normal injection of Enoxaparine
- Keywords
- enoxaparine, acute coronary syndrome, renal failure, dose adaptation
- Medical subject headings
- Acute Coronary Syndrome, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dose adaptation of EnoxaparinDrug
A same initial dose of 1 mg/kg will be administrated to all patients. According to creatinine clearance, the next doses (every 12 hours subcutaneously) will be adjusted with a 25% dose reduction if creatinine clearance is comprised between 30 and 50 ml/min.
normal injection of EnoxaparineDrug
No dose adaptation of Enoxaparine
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | dose adaptation of Enoxaparine at the renal deficient patients Receives: Drug: dose adaptation of Enoxaparin |
| 2 | Active comparator | No dose adaptation of Enoxaparine at renal normal patients Receives: Drug: normal injection of Enoxaparine |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma antiXa levels at peak after the fourth enoxaparine dose administration
Secondary outcomes (4)
residual plasma antiXa level before the fifth enoxaparine dose administration
activated thromboplastin time
thrombotic events
bleeding events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2006 (estimated)
- Study startDec 2006
- Primary completionMar 2009
- Study completionMar 2009
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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- French Cardiology Society
- Sponsor type
- University, hospital or other
- Investigators
- Imad ABI NASR, MD, Study chair, Ambroise Paré Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00412802
- Sponsor's protocol ID
- 2006-01
- Status last verified
- Jul 2011
- First submitted
- 15 Dec 2006
- Last updated
- 21 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Enoxaparin Dose Adaptation in Patients With Moderate Renal Failure Hospitalized for an Acute Coronary Syndrome, the VALIDE Study
- ClinicalTrials.gov ID
- NCT00412802
- Acronym / sponsor ID
- 2006-01
- Conditions
- Acute Coronary Syndrome, Renal Failure
- Keywords
- enoxaparine, acute coronary syndrome, renal failure, dose adaptation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- French Cardiology SocietyUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 18 Dec 2006 (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.
The objective of the VALIDE study is to validate that a 25% dose reduction of enoxaparine in patients with moderate renal failure (creatinine clearance between 30 and 50 ml/min) and hospitalized for an acute coronary syndrome provides at steady state a similar anti Xa level in plasma compared to that obtained in patients without renal failure and receiving the usual dose of 1 mg/kg subcutaneously every 12 hours. 140 per - protocol patients are planned to be included.
Detailed description
Included patients will be those hospitalized for an acute coronary syndrome with indication of enoxaparin treatment. A same initial dose of 1 mg/kg will be administrated to all patients. According to creatinine clearance, the next doses (every 12 hours subcutaneously) will be adjusted with a 25% dose reduction if creatinine clearance is comprised between 30 and 50 ml/min. After the fourth dose, the anti-Xa plasma levels (main endpoint) will be measured at peak (between 3 and 5 hours after dose administration). Residual values of antiXa will also be measured before the fifth dose administration (secondary criteria).
The objective is to demonstrate a bio-equivalence of efficacy on the anti-Xa values obtained in patients with moderate rela failure compared with patients with creatinine clearance higher than 50 ml/min.
Thrombotic and bleeding events will be recorded during hospitalisation. 140 per-protocol evaluable consecutive patients will have to be obtained: 70 with creatinine clearance higher than 50 ml/min and 70 patients with creatinin clearance between 30 and 50 ml/min.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: dose adaptation of Enoxaparindose adaptation of Enoxaparine at the renal deficient patients |
| 2 | Active comparator | Drug: normal injection of EnoxaparineNo dose adaptation of Enoxaparine at renal normal patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients hospitalized for acute coronary syndrome
- Indication of enoxaparin treatment
- Informed consent
Key exclusion criteria (9 listed)
- Myocardial infarction with ST elevation
- Inclusion later than 12 hours after the first enoxaparin dose administration
- Creatinine clearance lower than 30 ml/min
- History of thrombopenia induced by heparin
- Platelet count lower than 100.000 / mm3
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 |
|---|---|---|
| dose adaptation of EnoxaparinA same initial dose of 1 mg/kg will be administrated to all patients. According to creatinine clearance, the next doses (every 12 hours subcutaneously) will be adjusted with a 25% dose reduction if creatinine clearance is comprised between 30 and 50 ml/min. | Drug | 1 |
| normal injection of EnoxaparineNo dose adaptation of Enoxaparine | Drug | 2 |
Primary outcome
plasma antiXa levels at peak after the fourth enoxaparine dose administration
4 secondary outcomes
residual plasma antiXa level before the fifth enoxaparine dose administration
activated thromboplastin time
thrombotic events
bleeding events
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 21 Jul 2011.
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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.
Imad ABI NASR, MD study chair
Ambroise Paré Hospital
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing dose adaptation of Enoxaparin and normal injection of Enoxaparine in people with Acute Coronary Syndrome and Renal Failure, run by French Cardiology Society at 9 sites in France.
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 9 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 21 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. 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?
plasma antiXa levels at peak after the fourth enoxaparine dose administration. 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 21 Jul 2011.