Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:30 AM
Study NCT ID:
NCT00927602
Status:
TERMINATED
Last Update Posted:
2012-04-24
First Post:
2009-06-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fondaparinux 1,5 mg for the Prevention of Venous Thromboembolism (VTE) in Medical Patients With Renal Insufficiency
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D054556', 'term': 'Venous Thromboembolism'}], 'ancestors': [{'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'}, {'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077425', 'term': 'Fondaparinux'}], 'ancestors': [{'id': 'D009844', 'term': 'Oligosaccharides'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 206}}, 'statusModule': {'whyStopped': 'study was stopped after enrolment of about 200 patients for slow recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-23', 'studyFirstSubmitDate': '2009-06-24', 'studyFirstSubmitQcDate': '2009-06-24', 'lastUpdatePostDateStruct': {'date': '2012-04-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'major bleeding', 'timeFrame': 'up to 48 hours from last injection'}], 'secondaryOutcomes': [{'measure': 'symptomatic venous thromboembolism', 'timeFrame': 'last treatment dose'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['renal failure', 'medical patient', 'venous thromboembolism', 'prophylaxis', 'fondaparinux'], 'conditions': ['Medical Patients', 'Renal Insufficiency']}, 'referencesModule': {'references': [{'pmid': '16439370', 'type': 'BACKGROUND', 'citation': 'Cohen AT, Davidson BL, Gallus AS, Lassen MR, Prins MH, Tomkowski W, Turpie AG, Egberts JF, Lensing AW; ARTEMIS Investigators. Efficacy and safety of fondaparinux for the prevention of venous thromboembolism in older acute medical patients: randomised placebo controlled trial. BMJ. 2006 Feb 11;332(7537):325-9. doi: 10.1136/bmj.38733.466748.7C. Epub 2006 Jan 26.'}, {'pmid': '16670137', 'type': 'BACKGROUND', 'citation': 'Lim W, Dentali F, Eikelboom JW, Crowther MA. Meta-analysis: low-molecular-weight heparin and bleeding in patients with severe renal insufficiency. Ann Intern Med. 2006 May 2;144(9):673-84. doi: 10.7326/0003-4819-144-9-200605020-00011.'}, {'pmid': '22925036', 'type': 'DERIVED', 'citation': 'Ageno W, Riva N, Noris P, Di Nisio M, La Regina M, Arioli D, Ria L, Monzani V, Cuppini S, Lupia E, Giorgi Pierfranceschi M, Dentali F; FONDAIR study group. Safety and efficacy of low-dose fondaparinux (1.5 mg) for the prevention of venous thromboembolism in acutely ill medical patients with renal impairment: the FONDAIR study. J Thromb Haemost. 2012 Nov;10(11):2291-7. doi: 10.1111/j.1538-7836.2012.04908.x.'}]}, 'descriptionModule': {'briefSummary': 'Fondaparinux is a parenteral anticoagulant drug and is approved for the prevention of venous thromboembolism in high risk medical patients. A relevant proportion of medical patients have moderate to severe renal insufficiency, which is an independent risk factor for bleeding. This risk may be further increased when low molecular weight heparin or fondaparinux are administered in patients with severe renal insufficiency, defined by a creatinine clearance of lower than 30 mL/min. No clear indications are available to reduce such risk in patients who require thromboprophylaxis. A lower dose of fondaparinux, 1.5 mg daily, has been recently approved for the prevention of venous thromboembolism in the specific population of patients with a creatinine clearance between 20 and 50 mL/min (European Marketing Authorization). However, there are to our knowledge no clinical studies that have assessed the safety and efficacy of this reduced dosage in medical patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 60 years\n* Acute medical disease requiring thromboprophylaxis according to international guidelines\n* Anticipated immobilization of at least 4 days\n* Renal insufficiency defined by creatinine clearance between 20 and 50 mL/min according the MDRD formula\n* Written informed consent\n\nExclusion Criteria:\n\n* Active bleeding or bleeding in the previous 3 months\n* Known bleeding diathesis\n* Platelet count \\< 100.000\n* Ongoing treatment with unfractionated heparin, low molecular weight heparin, fondaparinux, or vitamin K antagonists\n* Use of prophylactic doses of heparin, low molecular weight heparin, or fondaparinux in the previous 72 hours\n* Life expectancy \\< 1 month'}, 'identificationModule': {'nctId': 'NCT00927602', 'briefTitle': 'Fondaparinux 1,5 mg for the Prevention of Venous Thromboembolism (VTE) in Medical Patients With Renal Insufficiency', 'organization': {'class': 'OTHER', 'fullName': "Università degli Studi dell'Insubria"}, 'officialTitle': 'The Safety and Efficacy of Fondaparinux 1,5 mg for the Prevention of Venous Thromboembolism in Medical Patients With Renal Insufficiency', 'orgStudyIdInfo': {'id': '2008-005234-79'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'fondaparinux', 'interventionNames': ['Drug: fondaparinux']}], 'interventions': [{'name': 'fondaparinux', 'type': 'DRUG', 'otherNames': ['Arixtra'], 'description': 'once daily sc injection, 1,5 mg, max 14 days', 'armGroupLabels': ['fondaparinux']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21100', 'city': 'Varese', 'country': 'Italy', 'facility': 'University Of Insubria', 'geoPoint': {'lat': 45.82058, 'lon': 8.82511}}], 'overallOfficials': [{'name': 'Walter Ageno, MD', 'role': 'STUDY_CHAIR', 'affiliation': "Università degli Studi dell'Insubria"}, {'name': 'Francesco Dentali, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': "Università degli Studi dell'Insubria"}, {'name': 'Alessandro Squizzato, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Università degli Studi dell'Insubria"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Università degli Studi dell'Insubria", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Internal Medicine', 'investigatorFullName': 'Walter Ageno', 'investigatorAffiliation': "Università degli Studi dell'Insubria"}}}}