Clinical trial NCT00412802: Adaptation Dose of Enoxaparin in Moderate Renal Failure Patients With Acute Coronary Syndrome
Official title: Validation of Enoxaparin Dose Adaptation in Patients With Moderate Renal Failure Hospitalized for an Acute Coronary Syndrome, the VALIDE Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Coronary Syndrome
Renal Failure
Keywords: enoxaparine
acute coronary syndrome
renal failure
dose adaptation
Lead sponsor: French Cardiology Society
Sponsor class: OTHER
First posted: 2006-12-18
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: plasma antiXa levels at peak after the fourth enoxaparine dose administration
Secondary outcomes:
measure: residual plasma antiXa level before the fifth enoxaparine dose administration
measure: activated thromboplastin time
measure: thrombotic events
measure: bleeding events
Other outcomes:
Locations:
city: Corbeil
country: France
facility: Sud Francilien Hospital center
state: Essonnes
city: Besançon
country: France
facility: CHU Jean MINJOZ
city: Boulogne
country: France
facility: Ambroise Paré Hospital
city: Creteil
country: France
facility: Henri Mondor Hospital
city: Lagny sur Marne
country: France
facility: Lagny center Hospital
city: Paris
country: France
facility: Pitié Salpêtrière Hospital
city: Paris
country: France
facility: CHU Bichat
city: Paris
country: France
facility: Lariboisiére Hospital
city: Toulouse
country: France
facility: Rangueil Hospital
Study officials:
affiliation: Ambroise Paré Hospital
name: Imad ABI NASR, MD
role: STUDY_CHAIR
References: