MedTrace Logo

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

NCT00412802 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2011-07-21

No results posted yet for this study

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.

Conditions

  • Acute Coronary Syndrome
  • Renal Failure

Interventions

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

Sponsors & Collaborators

  • French Cardiology Society

    lead OTHER

Principal Investigators

  • Imad ABI NASR, MD · Ambroise Paré Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2009-03-31
Completion
2009-03-31

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00412802 on ClinicalTrials.gov