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

French Cardiology Society

Status and phase: Completed; Phase 4

Conditions: Renal Failure; Acute Coronary Syndrome

Treatments: Drug: dose adaptation of Enoxaparin; Drug: normal injection of Enoxaparine

Study type: Interventional

Funder types: Other

Identifiers

NCT00412802

2006-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 67 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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67 participants in 2 patient groups

1

Experimental group

Description:

dose adaptation of Enoxaparine at the renal deficient patients

Treatment:

Drug: dose adaptation of Enoxaparin

2

Active Comparator group

Description:

No dose adaptation of Enoxaparine at renal normal patients

Treatment:

Drug: normal injection of Enoxaparine