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

Phase 4

Completed

• Conditions: Acute Coronary Syndrome; Renal Failure
• Interventions: Drug: dose adaptation of Enoxaparin; Drug: normal injection of Enoxaparine

• Registration Number: NCT00412802
• Lead Sponsor: French Cardiology Society

Brief 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.

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2006-12-15
• Study First Submitted QC: 2006-12-15
• Study First Posted: 2006-12-18
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-19
• Last Update Posted: 2011-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	dose adaptation of Enoxaparin	dose adaptation of Enoxaparine at the renal deficient patients
2	normal injection of Enoxaparine	No dose adaptation of Enoxaparine at renal normal patients

Primary Outcome Measures

Name	Time	Method
plasma antiXa levels at peak after the fourth enoxaparine dose administration

Secondary Outcome Measures

Name	Time	Method
residual plasma antiXa level before the fifth enoxaparine dose administration
activated thromboplastin time
thrombotic events
bleeding events

Trial Locations

Locations (9)

Henri Mondor Hospital; 🇫🇷 Creteil, France

Ambroise Paré Hospital; 🇫🇷 Boulogne, France

Sud Francilien Hospital center; 🇫🇷 Corbeil, Essonnes, France

CHU Jean MINJOZ; 🇫🇷 Besançon, France

Lagny center Hospital; 🇫🇷 Lagny sur Marne, France

CHU Bichat; 🇫🇷 Paris, France

Pitié Salpêtrière Hospital; 🇫🇷 Paris, France

Rangueil Hospital; 🇫🇷 Toulouse, France

Lariboisiére Hospital; 🇫🇷 Paris, France