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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | dose adaptation of Enoxaparine at the renal deficient patients |
|
| 2 | Active Comparator | No dose adaptation of Enoxaparine at renal normal patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dose adaptation of Enoxaparin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| plasma antiXa levels at peak after the fourth enoxaparine dose administration |
| Measure | Description | Time Frame |
|---|---|---|
| residual plasma antiXa level before the fifth enoxaparine dose administration | ||
| activated thromboplastin time | ||
| thrombotic events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Imad ABI NASR, MD | Ambroise Paré Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sud Francilien Hospital center | Corbeil | Essonnes | 91100 | France | ||
| CHU Jean MINJOZ |
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|
| normal injection of Enoxaparine | Drug | No dose adaptation of Enoxaparine |
|
| bleeding events |
| Besançon |
| 25030 |
| France |
| Ambroise Paré Hospital | Boulogne | 92100 | France |
| Henri Mondor Hospital | Créteil | 94010 | France |
| Lagny center Hospital | Lagny-sur-Marne | 77400 | France |
| Pitié Salpêtrière Hospital | Paris | 75013 | France |
| CHU Bichat | Paris | 75018 | France |
| Lariboisiére Hospital | Paris | 75475 | France |
| Rangueil Hospital | Toulouse | 31000 | France |
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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