Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:34 AM
Study NCT ID:
NCT00412802
Status:
COMPLETED
Last Update Posted:
2011-07-21
First Post:
2006-12-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Adaptation Dose of Enoxaparin in Moderate Renal Failure Patients With Acute Coronary Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-07-19', 'studyFirstSubmitDate': '2006-12-15', 'studyFirstSubmitQcDate': '2006-12-15', 'lastUpdatePostDateStruct': {'date': '2011-07-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-12-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'plasma antiXa levels at peak after the fourth enoxaparine dose administration'}], 'secondaryOutcomes': [{'measure': 'residual plasma antiXa level before the fifth enoxaparine dose administration'}, {'measure': 'activated thromboplastin time'}, {'measure': 'thrombotic events'}, {'measure': 'bleeding events'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['enoxaparine', 'acute coronary syndrome', 'renal failure', 'dose adaptation'], 'conditions': ['Acute Coronary Syndrome', 'Renal Failure']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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).\n\nThe 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.\n\nThrombotic 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients hospitalized for acute coronary syndrome\n* Indication of enoxaparin treatment\n* Informed consent\n\nExclusion Criteria:\n\n* Myocardial infarction with ST elevation\n* Inclusion later than 12 hours after the first enoxaparin dose administration\n* Creatinine clearance lower than 30 ml/min\n* History of thrombopenia induced by heparin\n* Platelet count lower than 100.000 / mm3\n* Age \\< 18\n* Pregnancy\n* History of hemorrhagic stroke\n* Contra-indication to enoxaparin'}, 'identificationModule': {'nctId': 'NCT00412802', 'briefTitle': 'Adaptation Dose of Enoxaparin in Moderate Renal Failure Patients With Acute Coronary Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'French Cardiology Society'}, 'officialTitle': 'Validation of Enoxaparin Dose Adaptation in Patients With Moderate Renal Failure Hospitalized for an Acute Coronary Syndrome, the VALIDE Study', 'orgStudyIdInfo': {'id': '2006-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'dose adaptation of Enoxaparine at the renal deficient patients', 'interventionNames': ['Drug: dose adaptation of Enoxaparin']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'No dose adaptation of Enoxaparine at renal normal patients', 'interventionNames': ['Drug: normal injection of Enoxaparine']}], 'interventions': [{'name': 'dose adaptation of Enoxaparin', 'type': 'DRUG', '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.', 'armGroupLabels': ['1']}, {'name': 'normal injection of Enoxaparine', 'type': 'DRUG', 'description': 'No dose adaptation of Enoxaparine', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91100', 'city': 'Corbeil', 'state': 'Essonnes', 'country': 'France', 'facility': 'Sud Francilien Hospital center', 'geoPoint': {'lat': 48.57727, 'lon': 4.42634}}, {'zip': '25030', 'city': 'Besançon', 'country': 'France', 'facility': 'CHU Jean MINJOZ', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '92100', 'city': 'Boulogne', 'country': 'France', 'facility': 'Ambroise Paré Hospital', 'geoPoint': {'lat': 46.79346, 'lon': -1.3194}}, {'zip': '94010', 'city': 'Créteil', 'country': 'France', 'facility': 'Henri Mondor Hospital', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '77400', 'city': 'Lagny-sur-Marne', 'country': 'France', 'facility': 'Lagny center Hospital', 'geoPoint': {'lat': 48.86667, 'lon': 2.71667}}, {'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'Pitié Salpêtrière Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75018', 'city': 'Paris', 'country': 'France', 'facility': 'CHU Bichat', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75475', 'city': 'Paris', 'country': 'France', 'facility': 'Lariboisiére Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '31000', 'city': 'Toulouse', 'country': 'France', 'facility': 'Rangueil Hospital', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Imad ABI NASR, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Ambroise Paré Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'French Cardiology Society', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr Anissa Bouzamondo', 'oldOrganization': 'French Society of Cardiology'}}}}