Adaptation Dose of Enoxaparin in Moderate Renal Failure Patients With Acute Coronary Syndrome
Primary Purpose
Acute Coronary Syndrome, Renal Failure
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
dose adaptation of Enoxaparin
normal injection of Enoxaparine
Sponsored by
About this trial
This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring enoxaparine, acute coronary syndrome, renal failure, dose adaptation
Eligibility 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
Sites / Locations
- Sud Francilien Hospital center
- CHU Jean MINJOZ
- Ambroise Paré Hospital
- Henri Mondor Hospital
- Lagny center Hospital
- Pitié Salpêtrière Hospital
- CHU Bichat
- Lariboisiére Hospital
- Rangueil Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
dose adaptation of Enoxaparine at the renal deficient patients
No dose adaptation of Enoxaparine at renal normal patients
Outcomes
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
Full Information
NCT ID
NCT00412802
First Posted
December 15, 2006
Last Updated
July 19, 2011
Sponsor
French Cardiology Society
1. Study Identification
Unique Protocol Identification Number
NCT00412802
Brief Title
Adaptation Dose of Enoxaparin in Moderate Renal Failure Patients With Acute Coronary Syndrome
Official Title
Validation of Enoxaparin Dose Adaptation in Patients With Moderate Renal Failure Hospitalized for an Acute Coronary Syndrome, the VALIDE Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
French Cardiology Society
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome, Renal Failure
Keywords
enoxaparine, acute coronary syndrome, renal failure, dose adaptation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
67 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
dose adaptation of Enoxaparine at the renal deficient patients
Arm Title
2
Arm Type
Active Comparator
Arm Description
No dose adaptation of Enoxaparine at renal normal patients
Intervention Type
Drug
Intervention Name(s)
dose adaptation of Enoxaparin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
normal injection of Enoxaparine
Intervention Description
No dose adaptation of Enoxaparine
Primary Outcome Measure Information:
Title
plasma antiXa levels at peak after the fourth enoxaparine dose administration
Secondary Outcome Measure Information:
Title
residual plasma antiXa level before the fifth enoxaparine dose administration
Title
activated thromboplastin time
Title
thrombotic events
Title
bleeding events
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Imad ABI NASR, MD
Organizational Affiliation
Ambroise Paré Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Sud Francilien Hospital center
City
Corbeil
State/Province
Essonnes
ZIP/Postal Code
91100
Country
France
Facility Name
CHU Jean MINJOZ
City
Besançon
ZIP/Postal Code
25030
Country
France
Facility Name
Ambroise Paré Hospital
City
Boulogne
ZIP/Postal Code
92100
Country
France
Facility Name
Henri Mondor Hospital
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
Lagny center Hospital
City
Lagny sur Marne
ZIP/Postal Code
77400
Country
France
Facility Name
Pitié Salpêtrière Hospital
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
CHU Bichat
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
Lariboisiére Hospital
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Rangueil Hospital
City
Toulouse
ZIP/Postal Code
31000
Country
France
12. IPD Sharing Statement
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Adaptation Dose of Enoxaparin in Moderate Renal Failure Patients With Acute Coronary Syndrome
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