Adaptation Dose of Enoxaparin in Moderate Renal Failure Patients With Acute Coronary Syndrome
Validation of Enoxaparin Dose Adaptation in Patients With Moderate Renal Failure Hospitalized for an Acute Coronary Syndrome, the VALIDE Study
1 other identifier
interventional
67
1 country
9
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Dec 2006
Typical duration for phase_4
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2006
CompletedFirst Submitted
Initial submission to the registry
December 15, 2006
CompletedFirst Posted
Study publicly available on registry
December 18, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedJuly 21, 2011
July 1, 2011
2.2 years
December 15, 2006
July 19, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
plasma antiXa levels at peak after the fourth enoxaparine dose administration
Secondary Outcomes (4)
residual plasma antiXa level before the fifth enoxaparine dose administration
activated thromboplastin time
thrombotic events
bleeding events
Study Arms (2)
1
EXPERIMENTALdose adaptation of Enoxaparine at the renal deficient patients
2
ACTIVE COMPARATORNo dose adaptation of Enoxaparine at renal normal patients
Interventions
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.
Eligibility Criteria
You may qualify if:
- Patients hospitalized for acute coronary syndrome
- Indication of enoxaparin treatment
- Informed consent
You may not qualify if:
- Myocardial infarction with ST elevation
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Sud Francilien Hospital center
Corbeil, Essonnes, 91100, France
CHU Jean MINJOZ
Besançon, 25030, France
Ambroise Paré Hospital
Boulogne, 92100, France
Henri Mondor Hospital
Créteil, 94010, France
Lagny center Hospital
Lagny-sur-Marne, 77400, France
Pitié Salpêtrière Hospital
Paris, 75013, France
CHU Bichat
Paris, 75018, France
Lariboisiére Hospital
Paris, 75475, France
Rangueil Hospital
Toulouse, 31000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Imad ABI NASR, MD
Ambroise Paré Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 15, 2006
First Posted
December 18, 2006
Study Start
December 1, 2006
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
July 21, 2011
Record last verified: 2011-07