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

Acute Coronary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00412802
• Other study ID #: 2006-01
• Status: Completed
• Phase: Phase 4
• First received: December 15, 2006
• Last updated: July 19, 2011
• Start date: December 2006
• Est. completion date: March 2009

Study information

• Verified date: July 2011
• Source: French Cardiology Society
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Renal Failure
• Renal Insufficiency
• Syndrome

Intervention

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.
• normal injection of Enoxaparine
No dose adaptation of Enoxaparine

Locations

Country	Name	City	State
France	CHU Jean MINJOZ	Besançon
France	Ambroise Paré Hospital	Boulogne
France	Sud Francilien Hospital center	Corbeil	Essonnes
France	Henri Mondor Hospital	Creteil
France	Lagny center Hospital	Lagny sur Marne
France	CHU Bichat	Paris
France	Lariboisiére Hospital	Paris
France	Pitié Salpêtrière Hospital	Paris
France	Rangueil Hospital	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
French Cardiology Society

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	plasma antiXa levels at peak after the fourth enoxaparine dose administration
Secondary	residual plasma antiXa level before the fifth enoxaparine dose administration
Secondary	activated thromboplastin time
Secondary	thrombotic events
Secondary	bleeding events