NCT00412802

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: French Cardiology Society · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Acute Coronary Syndrome
• Renal Failure

Interventions

Type	Name	Description
DRUG	dose adaptation of Enoxaparin	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.
DRUG	normal injection of Enoxaparine	No dose adaptation of Enoxaparine

Timeline

• Start date: 2006-12-01
• Primary completion: 2009-03-01
• Completion: 2009-03-01
• First posted: 2006-12-18
• Last updated: 2011-07-21

Locations

9 sites across 1 country: France