Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2025-12-30 @ 3:47 PM
Study NCT ID:
NCT00365950
Status:
COMPLETED
Last Update Posted:
2006-08-18
First Post:
2006-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
3 Months' Versus 6 Months' Anticoagulation in Patients With DVT and/or PE
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020246', 'term': 'Venous Thrombosis'}, {'id': 'D011655', 'term': 'Pulmonary Embolism'}], 'ancestors': [{'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D004617', 'term': 'Embolism'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 2400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2004-01', 'completionDateStruct': {'date': '2003-12'}, 'lastUpdateSubmitDate': '2006-08-17', 'studyFirstSubmitDate': '2006-08-17', 'studyFirstSubmitQcDate': '2006-08-17', 'lastUpdatePostDateStruct': {'date': '2006-08-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-08-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Death due to DVT/PE'}, {'measure': 'Failures of resolution, extension or recurrence of DVT and/or PE during and after treatment.'}, {'measure': 'Number of major haemorrhages.'}], 'secondaryOutcomes': [{'measure': 'Comparison of length of Hospital stay between those given unfractionated heparin and those given low molecular weight heparin.'}]}, 'conditionsModule': {'keywords': ['Duration of anticoagulation', 'Deep vein thrombosis and/or pulmonary embolism'], 'conditions': ['Deep Vein Thrombosis', 'Pulmonary Embolism', 'Deep Vein Thrombosis With Pulmonary Embolism']}, 'referencesModule': {'references': [{'pmid': '17289685', 'type': 'DERIVED', 'citation': 'Campbell IA, Bentley DP, Prescott RJ, Routledge PA, Shetty HG, Williamson IJ. Anticoagulation for three versus six months in patients with deep vein thrombosis or pulmonary embolism, or both: randomised trial. BMJ. 2007 Mar 31;334(7595):674. doi: 10.1136/bmj.39098.583356.55. Epub 2007 Feb 8.'}]}, 'descriptionModule': {'briefSummary': "To determine whether 3 months' anticoagulation is as good as or better than 6 months' for the treatment of DVT/PE", 'detailedDescription': "Multi-centre trial involving 46 hospitals in the United Kingdom, with patients entered by 137 Consultant Physicians. Consenting patients were randomised in a central office to either 3 months' or 6 months' anticoagulation. Information on progress of the patients was requested by the co-ordinating office at 3 months, 6 months and 12 months. Outcomes were measured as death from DVT/PE, non-fatal extensions or recurrences of DVT/PE and major haemorrhages during and after anticoagulation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18 years or more with suspected or proven DVT/PE whom the clinician intended to anticoagulate.\n\nExclusion Criteria:\n\n* DVT/PE severe enough to require thrombolysis or pulmonary embolectomy.\n* DVT/PE in the preceding 3 years.\n* Neoplasia diagnosed/treated within previous 3 years.\n* Pregnancy.\n* Known major thrombophilias.\n* Prolonged or continuous immobility or confinement to bed.\n* Previous allergy to heparin or warfarin.\n* Requirement for long-term anticoagulation.\n* Inability to give informed consent.'}, 'identificationModule': {'nctId': 'NCT00365950', 'briefTitle': "3 Months' Versus 6 Months' Anticoagulation in Patients With DVT and/or PE", 'organization': {'class': 'OTHER', 'fullName': 'British Thoracic Society'}, 'officialTitle': 'Clinical Trial of Two Durations of Warfarin Therapy in the Treatment of Deep Vein Thrombosis and/or Pulmonary Embolism', 'orgStudyIdInfo': {'id': 'BTS DVT/PE Study'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Duration of anticoagulation', 'type': 'DRUG'}, {'name': 'Warfarin duration', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CF62 2XX', 'city': 'Cardiff', 'state': 'Wales', 'country': 'United Kingdom', 'facility': 'Department of Chest Medicine, Llandough Hospital', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}, {'zip': 'CF64 2XX', 'city': 'Cardiff', 'state': 'Wales', 'country': 'United Kingdom', 'facility': 'Department of Chest Medicine, Llandough Hospital,', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}], 'overallOfficials': [{'name': 'Aziz Sheikh, MD,FRCGP', 'role': 'STUDY_CHAIR', 'affiliation': 'Research Committee of the British Thoracic Society'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'British Thoracic Society', 'class': 'OTHER'}}}}