Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:10 AM
Study NCT ID:
NCT00689520
Status:
COMPLETED
Last Update Posted:
2008-06-03
First Post:
2008-05-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Long-Term Low-Molecular-Weight Heparin Versus Oral Anticoagulants in Deep Venous Thrombosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054556', 'term': 'Venous Thromboembolism'}], 'ancestors': [{'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078222', 'term': 'Tinzaparin'}, {'id': 'D000074', 'term': 'Acenocoumarol'}, {'id': 'C008208', 'term': 'acarboxyprothrombin'}], 'ancestors': [{'id': 'D006495', 'term': 'Heparin, Low-Molecular-Weight'}, {'id': 'D006493', 'term': 'Heparin'}, {'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D015110', 'term': '4-Hydroxycoumarins'}, {'id': 'D003374', 'term': 'Coumarins'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 241}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-05', 'completionDateStruct': {'date': '2005-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-06-02', 'studyFirstSubmitDate': '2008-05-28', 'studyFirstSubmitQcDate': '2008-06-02', 'lastUpdatePostDateStruct': {'date': '2008-06-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of symptomatic recurrent venous thromboembolism', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Occurrence of major bleeding', 'timeFrame': '6 month treatment interval'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Venous thromboembolism', 'low molecular weight heparin', 'Vitamin K antagonist', 'Longterm'], 'conditions': ['Venous Thromboembolism']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate whether low-molecular-weight heparin could be equally or more effective than oral anticoagulation in the long-term treatment of deep venous thrombosis.', 'detailedDescription': 'The open-label prospective randomized clinical trial compares subcutaneous LMWH (tinzaparin)administered for 6 months versus initial treatment using subcutaneous LMWH followed by oral anticoagulants given for a similar period of time in patients with proximal venous thrombosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Consecutive, symptomatic patients with a first or recurrent episode of acute proximal-vein thrombosis of the lower limbs.\n* either sex and over 18 years of age\n* referred to the Vascular Surgery Department of the hospital\n* onset of symptoms less than 2 weeks\n* documented by compression ultrasonography,\n\nExclusion Criteria:\n\n* received heparin, low-molecular-weight heparin or oral anticoagulant therapy for more than 2 days for the present disease\n* pulmonary embolism requiring thrombolytic therapy\n* Need of surgical thrombectomy or vena cava interruption\n* receiving oral anticoagulant treatment or antiplatelet agents for other conditions\n* contraindication to anticoagulant treatment (active bleeding, severe blood pressure or allergy to the study drugs)\n* platelet count lower than 100x103 /μl or hemoglobin concentration lower than 7 g/dl or history of heparin-associated thrombocytopenia\n* severe renal failure necessitating dialysis\n* pregnancy\n* lumbar puncture within the previous 24 hours'}, 'identificationModule': {'nctId': 'NCT00689520', 'briefTitle': 'Long-Term Low-Molecular-Weight Heparin Versus Oral Anticoagulants in Deep Venous Thrombosis', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitari de Bellvitge'}, 'officialTitle': 'Phase IV, Randomized, Open-Label Trial Comparing Long-Term Subcutaneous Low-Molecular Weight Heparin With Oral Anticoagulant Therapy in the Treatment of Deep Venous Thrombosis', 'orgStudyIdInfo': {'id': 'CV1/01'}, 'secondaryIdInfos': [{'id': 'CV1/01'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'tinzaparin', 'description': 'tinzaparin (Innohep®) subcutaneously in a fixed dose of 175 IU anti-Xa/kg of body weight once daily for 6 months.', 'interventionNames': ['Drug: tinzaparin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'acenocoumarol', 'description': 'tinzaparin for 1 weeks followed by acenocoumarol for 6 months', 'interventionNames': ['Drug: acenocoumarol']}], 'interventions': [{'name': 'tinzaparin', 'type': 'DRUG', 'otherNames': ['innohep'], 'description': 'tinzaparin (Innohep®) subcutaneously in a fixed dose of 175 IU anti-Xa/kg of body weight once daily for 6 months', 'armGroupLabels': ['tinzaparin']}, {'name': 'acenocoumarol', 'type': 'DRUG', 'otherNames': ['Vitamin K antagonists'], 'description': 'tinzaparin subcutaneously 175 IU anti-Xa/kg of body weight once daily for 7 days followed by acenocoumarol for 6 months', 'armGroupLabels': ['acenocoumarol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08906', 'city': "L'Hospitalet de Llobregat", 'state': 'Barcelona', 'country': 'Spain', 'facility': "Vascular surgery service. Hospital Creu Roja de l'Hospitalet", 'geoPoint': {'lat': 41.35967, 'lon': 2.10028}}, {'zip': '08907', 'city': "L'Hospitalet de Llobregat", 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Department of Vascular Surgery. Hospital Universitari de Bellvitge', 'geoPoint': {'lat': 41.35967, 'lon': 2.10028}}], 'overallOfficials': [{'name': 'Antoni Romera, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital Universitari de Bellvitge'}, {'name': 'Antoni Romera, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitari de Bellvitge'}, {'name': 'Oriol Lapiedra, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Hospital Creu Roja de l'Hospitalet"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitari de Bellvitge', 'class': 'OTHER'}, 'collaborators': [{'name': 'LEO Pharma', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Romera, Antonio MD', 'oldOrganization': 'Department of Vascular Surgery. Hospital Universitari de Bellvitge'}}}}