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Sponsored by: |
French Cardiology Society |
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Information provided by: | French Cardiology Society |
ClinicalTrials.gov Identifier: | NCT00412802 |
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. |
Estimated Enrollment: | 160 |
Study Start Date: | December 2006 |
Estimated Study Completion Date: | September 2008 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
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 |
Study Chair: | Philippe LECHAT, MD,PhD | Pitié Salpêtriére Hospital |
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 |
enoxaparine acute coronary syndrome renal failure dose adaptation |
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 |
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 |