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

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: French Cardiology Society
• Treatments: Enoxaparin; Enoxaparin sodium

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