Adaptation Dose of Enoxaparin in Moderate Renal Failure Patients With Acute Coronary Syndrome

Study Overview
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Brief Summary
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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
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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.

Official Title
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Validation of Enoxaparin Dose Adaptation in Patients With Moderate Renal Failure Hospitalized for an Acute Coronary Syndrome, the VALIDE Study

Conditions
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Acute Coronary Syndrome, Renal Failure

Intervention / Treatment
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* Drug: dose adaptation of Enoxaparin
* Drug: normal injection of Enoxaparine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients hospitalized for acute coronary syndrome Indication of enoxaparin treatment Informed consent Exclusion Criteria: 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 Pregnancy History of hemorrhagic stroke Contra-indication to enoxaparin

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>dose adaptation of Enoxaparine at the renal deficient patients | Drug: dose adaptation of Enoxaparin<br>* 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.<br>|
| Active Comparator: 2<br>No dose adaptation of Enoxaparine at renal normal patients | Drug: normal injection of Enoxaparine<br>* No dose adaptation of Enoxaparine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma antiXa levels at peak after the fourth enoxaparine dose administration |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| residual plasma antiXa level before the fifth enoxaparine dose administration |  |  | 
| activated thromboplastin time |  |  | 
| thrombotic events |  |  | 
| bleeding events |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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enoxaparine, acute coronary syndrome, renal failure, dose adaptation