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

This study has been completed.
Sponsor:
Information provided by:
French Cardiology Society
ClinicalTrials.gov Identifier:
NCT00412802
First received: December 15, 2006
Last updated: July 19, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention Phase
Acute Coronary Syndrome
Renal Failure
Drug: dose adaptation of Enoxaparin
Drug: normal injection of Enoxaparine
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Validation of Enoxaparin Dose Adaptation in Patients With Moderate Renal Failure Hospitalized for an Acute Coronary Syndrome, the VALIDE Study

Further study details as provided by French Cardiology Society:

Primary Outcome Measures:
  • plasma antiXa levels at peak after the fourth enoxaparine dose administration

Secondary Outcome Measures:
  • residual plasma antiXa level before the fifth enoxaparine dose administration
  • activated thromboplastin time
  • thrombotic events
  • bleeding events

Enrollment: 67
Study Start Date: December 2006
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
dose adaptation of Enoxaparine at the renal deficient patients
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.
Active Comparator: 2
No dose adaptation of Enoxaparine at renal normal patients
Drug: normal injection of Enoxaparine
No dose adaptation of Enoxaparine

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00412802

Locations
France
Sud Francilien Hospital center
Corbeil, Essonnes, France, 91100
CHU Jean MINJOZ
Besançon, France, 25030
Ambroise Paré Hospital
Boulogne, France, 92100
Henri Mondor Hospital
Creteil, France, 94010
Lagny center Hospital
Lagny sur Marne, France, 77400
Lariboisiére Hospital
Paris, France, 75475
Pitié Salpêtrière Hospital
Paris, France, 75013
CHU Bichat
Paris, France, 75018
Rangueil Hospital
Toulouse, France, 31000
Sponsors and Collaborators
French Cardiology Society
Investigators
Study Chair: Imad ABI NASR, MD Ambroise Paré Hospital
  More Information

No publications provided

Responsible Party: Dr Anissa Bouzamondo, French Society of Cardiology
ClinicalTrials.gov Identifier: NCT00412802     History of Changes
Other Study ID Numbers: 2006-01
Study First Received: December 15, 2006
Last Updated: July 19, 2011
Health Authority: France: Ministry of Health

Keywords provided by French Cardiology Society:
enoxaparine
acute coronary syndrome
renal failure
dose adaptation

Additional relevant MeSH terms:
Acute Coronary Syndrome
Renal Insufficiency
Syndrome
Angina Pectoris
Cardiovascular Diseases
Chest Pain
Disease
Heart Diseases
Kidney Diseases
Myocardial Ischemia
Pain
Pathologic Processes
Signs and Symptoms
Urologic Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014