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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.
Details
| Lead sponsor | French Cardiology Society |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 67 |
| Start date | 2006-12 |
| Completion | 2009-03 |
Conditions
- Acute Coronary Syndrome
- Renal Failure
Interventions
- dose adaptation of Enoxaparin
- normal injection of Enoxaparine
Primary outcomes
- plasma antiXa levels at peak after the fourth enoxaparine dose administration
Countries
France