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

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.

Study Overview

• Status: Completed
• Conditions: Renal Failure; Acute Coronary Syndrome
• Intervention / Treatment: Drug: dose adaptation of Enoxaparin; Drug: normal injection of Enoxaparine

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 Type: Interventional
• Enrollment (Actual): 67
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Besançon, France, 25030
    • Chu Jean Minjoz
  • Boulogne, France, 92100
    • Ambroise Paré Hospital
  • Creteil, France, 94010
    • Henri Mondor Hospital
  • Lagny sur Marne, France, 77400
    • Lagny center Hospital
  • Paris, France, 75013
    • Pitie Salpetriere Hospital
  • Paris, France, 75018
    • CHU Bichat
  • Paris, France, 75475
    • Lariboisiere Hospital
  • Toulouse, France, 31000
    • Rangueil Hospital
  • Essonnes
    • Corbeil, Essonnes, France, 91100
      • Sud Francilien Hospital center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; dose adaptation of Enoxaparine at the renal deficient patients	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.
Active Comparator: 2; No dose adaptation of Enoxaparine at renal normal patients	Drug: normal injection of Enoxaparine; No dose adaptation of Enoxaparine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
plasma antiXa levels at peak after the fourth enoxaparine dose administration

Secondary Outcome Measures

Outcome Measure
residual plasma antiXa level before the fifth enoxaparine dose administration
activated thromboplastin time
thrombotic events
bleeding events

Collaborators and Investigators

• Sponsor: French Cardiology Society
• Investigators: Study Chair: Imad ABI NASR, MD, Ambroise Paré Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2006
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: December 15, 2006
• First Submitted That Met QC Criteria: December 15, 2006
• First Posted (Estimate): December 18, 2006

Study Record Updates

• Last Update Posted (Estimate): July 21, 2011
• Last Update Submitted That Met QC Criteria: July 19, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: acute coronary syndrome; renal failure; enoxaparine; dose adaptation
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Kidney Diseases; Urologic Diseases; Disease; Syndrome; Renal Insufficiency; Acute Coronary Syndrome; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Enoxaparin; Enoxaparin sodium
• Other Study ID Numbers: 2006-01