Ignite Creation Date:
2025-12-24 @ 3:36 PM
Ignite Modification Date:
2025-12-26 @ 6:05 AM
Study NCT ID:
NCT00437892
Status:
TERMINATED
Last Update Posted:
2011-08-19
First Post:
2007-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Statins to Reduce D-dimer Levels in Patients With Venous Thrombosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054556', 'term': 'Venous Thromboembolism'}, {'id': 'D006937', 'term': 'Hypercholesterolemia'}], 'ancestors': [{'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069059', 'term': 'Atorvastatin'}, {'id': 'D004032', 'term': 'Diet'}], 'ancestors': [{'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'whyStopped': 'Competitive trials and slow recruitment rate', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-18', 'studyFirstSubmitDate': '2007-02-20', 'studyFirstSubmitQcDate': '2007-02-20', 'lastUpdatePostDateStruct': {'date': '2011-08-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-02-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'proportion of patients with elevated D-dimer at day 90', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'proportion of patients with elevated D-dimer levels at Day 30;', 'timeFrame': '1 month'}, {'measure': 'proportion of patients with elevated D-dimer levels at Day 0 and subsequent normalization of D-dimer levels at Day 30 and Day 90;', 'timeFrame': '3 months'}, {'measure': 'proportion of patients with recurrent VTE', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Statins', 'secondary prevention', 'venous thromboembolism', 'd-dimer'], 'conditions': ['Venous Thromboembolism', 'Hypercholesterolemia']}, 'referencesModule': {'references': [{'pmid': '17065639', 'type': 'BACKGROUND', 'citation': 'Palareti G, Cosmi B, Legnani C, Tosetto A, Brusi C, Iorio A, Pengo V, Ghirarduzzi A, Pattacini C, Testa S, Lensing AW, Tripodi A; PROLONG Investigators. D-dimer testing to determine the duration of anticoagulation therapy. N Engl J Med. 2006 Oct 26;355(17):1780-9. doi: 10.1056/NEJMoa054444.'}, {'pmid': '16961599', 'type': 'BACKGROUND', 'citation': 'Squizzato A, Romualdi E, Ageno W. Why should statins prevent venous thromboembolism? A systematic literature search and a call for action. J Thromb Haemost. 2006 Sep;4(9):1925-7. doi: 10.1111/j.1538-7836.2006.02030.x. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Elevated levels of D-dimer, a marker of procoagulant state, have been identified as a marker of an increased risk of recurrent VTE. Statins have proven antithrombotic properties, as suggested by the reduction of several prothrombotic markers, including D-dimer, in patients at high risk of arterial thrombosis. Such antithrombotic properties could also be observed in patients at high risk of venous thrombosis. Aim of the study is to assess the effect of statins on D-dimer levels in patients with previous VTE after oral anticoagulant treatment withdrawal.', 'detailedDescription': 'Patients with a single episode of idiopathic VTE (either DVT or pulmonary embolism) who received at least 6 months of adequate treatment with oral anticoagulants, for whom treatment withdrawal is planned, and with LDL cholesterol levels of equal to or greater than 130 mg/dL will be randomized to either atorvastatin, 40 mg, 1 tablet daily and lipid lowering diet or lipid lowering diet for 3 months. On the day of oral anticoagulant treatment withdrawal (Day 0), enrolled patients will undergo measurement of plasma D-dimer. At 30 days ± 3 (Day 30), patients will undergo measurement of D-dimer, CK, LDH, ALAT e ASAT and clinical evaluation. At 90 days ± 7 (Day 90), patients will undergo measurement of D-dimer, total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides ed clinical evaluation, CK, LDH, ALAT e ASAT. At 6 months ± 1 (Day 180), patients will undergo clinical evaluation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients with a single episode of idiopathic VTE (either DVT or pulmonary embolism) who received at least 6 months of adequate treatment with oral anticoagulants, for whom treatment withdrawal is planned, and with LDL cholesterol levels of equal to or greater than 130 mg/dL.\n\nExclusion Criteria:\n\n* Age below 18 years,\n* Pregnancy or puerperium,\n* Active malignancy,\n* Need for other anticoagulant treatments (unfractionated heparin, low molecular weight heparin),\n* Presence of transient risk factors for VTE \\[recent (\\< 3 months) surgery,\n* Trauma,\n* Fractures,\n* Acute medical disease with immobilization,\n* Pregnancy or use of oral contraceptives\\],\n* Contraindications to statin therapy,\n* Chronic renal failure (defined by creatinine clearance \\< 30 mL/min),\n* Ongoing treatment with statins or fibrates,\n* Major indication to statin therapy \\[history of cardiovascular disease, diabetes, elevated cardiovascular risk according to the ATP III criteria(19)\\],\n* Life expectancy of less than 6 months,\n* Geographic inaccessibility,\n* Concomitant enrolment in another clinical trial,\n* Refused informed consent.'}, 'identificationModule': {'nctId': 'NCT00437892', 'briefTitle': 'Statins to Reduce D-dimer Levels in Patients With Venous Thrombosis', 'organization': {'class': 'OTHER', 'fullName': "Università degli Studi dell'Insubria"}, 'officialTitle': 'The Effect of Statins on D-dimer Levels in Patients With a Previous Venous Thromboembolic Event', 'orgStudyIdInfo': {'id': '7948'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Atorvastatin and lipid lowering diet', 'interventionNames': ['Drug: atorvastatin', 'Behavioral: diet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'lipid lowering diet', 'interventionNames': ['Behavioral: diet']}], 'interventions': [{'name': 'atorvastatin', 'type': 'DRUG', 'description': 'tablets, 40 mg day, 3 months', 'armGroupLabels': ['Atorvastatin and lipid lowering diet']}, {'name': 'atorvastatin', 'type': 'DRUG', 'description': 'tablets, 40 mg once daily', 'armGroupLabels': ['Atorvastatin and lipid lowering diet']}, {'name': 'diet', 'type': 'BEHAVIORAL', 'description': 'daily', 'armGroupLabels': ['lipid lowering diet']}, {'name': 'diet', 'type': 'BEHAVIORAL', 'description': 'daily diet', 'armGroupLabels': ['Atorvastatin and lipid lowering diet', 'lipid lowering diet']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bologna', 'country': 'Italy', 'facility': 'University of Bologna', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'city': 'Piacenza', 'country': 'Italy', 'facility': 'Ospedale di Piacenza', 'geoPoint': {'lat': 45.05242, 'lon': 9.69342}}, {'zip': '21100', 'city': 'Varese', 'country': 'Italy', 'facility': 'University Of Insubria', 'geoPoint': {'lat': 45.82058, 'lon': 8.82511}}], 'overallOfficials': [{'name': 'Walter Ageno', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Università degli Studi dell'Insubria"}, {'name': 'Gualtiero Palareti', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Bologna'}, {'name': 'Davide Imberti', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Piacenza Hospital'}]}, '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"}}}}