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Adaptation Dose of Enoxaparin in Moderate Renal Failure Patients With Acute Coronary Syndrome.
This study is not yet open for participant recruitment.
Verified by French Cardiology Society, December 2006
First Received: December 15, 2006   No Changes Posted
Sponsored by: French Cardiology Society
Information provided by: French Cardiology Society
ClinicalTrials.gov Identifier: NCT00412802
  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
Phase IV

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Bio-equivalence Study
Official Title: Validation of Enoxaparin Dose Adaptation in Patients With Moderate Renal Failure Hospitalized for an Acute Coronary Syndrome, the VALIDE Study.

Resource links provided by NLM:


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

Estimated Enrollment: 160
Study Start Date: December 2006
Estimated Study Completion Date: September 2008
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00412802

Contacts
Contact: philippe P Lechat, MD/PhD 33 1 42 16 16 82 philippe.lechat@psl.aphp.fr
Contact: anissa A Bouzamondo, Md 33 1 42 16 16 73 anissa.bouzamondo@psl.aphp.fr

Locations
France
Pitié Salpêtrière Hospital
Paris, France, 75013
Ambroise Paré Hospital
Boulogne, France, 92100
Lariboisiére Hospital
PARIS, France, 75475
CHU Bichat
Paris, France, 75018
Henri Mondor Hospital
Creteil, France, 94010
Lagny center Hospital
Lagny sur Marne, France, 77400
CHU Jean MINJOZ
Besançon, France, 25030
CHU Albi
ALBI, France, 81000
France, Essonnes
Sud Francilien Hospital center
Corbeil, Essonnes, France, 91100
Sponsors and Collaborators
French Cardiology Society
Investigators
Study Chair: Philippe LECHAT, MD,PhD Pitié Salpêtriére Hospital
  More Information

No publications provided

Study ID Numbers: 2006-01
Study First Received: December 15, 2006
Last Updated: December 15, 2006
ClinicalTrials.gov Identifier: NCT00412802     History of Changes
Health Authority: France: Ministry of Health

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

Study placed in the following topic categories:
Renal Insufficiency
Heart Diseases
Anticoagulants
Myocardial Ischemia
Vascular Diseases
Fibrinolytic Agents
Cardiovascular Agents
Ischemia
Enoxaparin
Fibrin Modulating Agents
Urologic Diseases
Acute Coronary Syndrome
Kidney Diseases
Kidney Failure

Additional relevant MeSH terms:
Renal Insufficiency
Anticoagulants
Disease
Heart Diseases
Molecular Mechanisms of Pharmacological Action
Myocardial Ischemia
Hematologic Agents
Vascular Diseases
Fibrinolytic Agents
Cardiovascular Agents
Pharmacologic Actions
Enoxaparin
Fibrin Modulating Agents
Pathologic Processes
Urologic Diseases
Therapeutic Uses
Syndrome
Acute Coronary Syndrome
Cardiovascular Diseases
Kidney Diseases
Kidney Failure

ClinicalTrials.gov processed this record on September 11, 2009