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NCT Number: NCT00412802

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

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.

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Key information

Conditions

Acute Coronary Syndrome Cardiovascular Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Diseases Kidney Diseases Male Urogenital Diseases Myocardial Ischemia Renal Failure Renal Insufficiency Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sud Francilien Hospital center, Corbeil, Essonnes, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dose adaptation of Enoxaparin

Drug

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.

normal injection of Enoxaparine

Drug

No dose adaptation of Enoxaparine

Primary outcomes

  1. plasma antiXa levels at peak after the fourth enoxaparine dose administration

Secondary outcomes

  1. residual plasma antiXa level before the fifth enoxaparine dose administration

  2. activated thromboplastin time

  3. thrombotic events

  4. bleeding events

Sponsors and collaborators

Lead sponsor

French Cardiology Society

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Dec 18, 2006
Registry last updated
Jul 21, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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