Back to results3 Months' Versus 6 Months' Anticoagulation in Patients With DVT and/or PE
Primary Purpose
Deep Vein Thrombosis, Pulmonary Embolism, Deep Vein Thrombosis With Pulmonary Embolism
Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Duration of anticoagulation
Warfarin duration
Sponsored by
About this trial
This is an interventional treatment trial for Deep Vein Thrombosis focused on measuring Duration of anticoagulation, Deep vein thrombosis and/or pulmonary embolism
Eligibility Criteria
Inclusion Criteria: Patients aged 18 years or more with suspected or proven DVT/PE whom the clinician intended to anticoagulate. Exclusion Criteria: DVT/PE severe enough to require thrombolysis or pulmonary embolectomy. DVT/PE in the preceding 3 years. Neoplasia diagnosed/treated within previous 3 years. Pregnancy. Known major thrombophilias. Prolonged or continuous immobility or confinement to bed. Previous allergy to heparin or warfarin. Requirement for long-term anticoagulation. Inability to give informed consent.
Sites / Locations
- Department of Chest Medicine, Llandough Hospital
- Department of Chest Medicine, Llandough Hospital,
Outcomes
Primary Outcome Measures
Death due to DVT/PE
Failures of resolution, extension or recurrence of DVT and/or PE during and after treatment.
Number of major haemorrhages.
Secondary Outcome Measures
Comparison of length of Hospital stay between those given unfractionated heparin and those given low molecular weight heparin.
Full Information
NCT ID
NCT00365950
First Posted
August 17, 2006
Last Updated
August 17, 2006
Sponsor
British Thoracic Society
1. Study Identification
Unique Protocol Identification Number
NCT00365950
Brief Title
3 Months' Versus 6 Months' Anticoagulation in Patients With DVT and/or PE
Official Title
Clinical Trial of Two Durations of Warfarin Therapy in the Treatment of Deep Vein Thrombosis and/or Pulmonary Embolism
Study Type
Interventional
2. Study Status
Record Verification Date
January 2004
Overall Recruitment Status
Completed
Study Start Date
September 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2003 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
British Thoracic Society
4. Oversight
5. Study Description
Brief Summary
To determine whether 3 months' anticoagulation is as good as or better than 6 months' for the treatment of DVT/PE
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deep Vein Thrombosis, Pulmonary Embolism, Deep Vein Thrombosis With Pulmonary Embolism
Keywords
Duration of anticoagulation, Deep vein thrombosis and/or pulmonary embolism
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2400 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Duration of anticoagulation
Intervention Type
Drug
Intervention Name(s)
Warfarin duration
Primary Outcome Measure Information:
Title
Death due to DVT/PE
Title
Failures of resolution, extension or recurrence of DVT and/or PE during and after treatment.
Title
Number of major haemorrhages.
Secondary Outcome Measure Information:
Title
Comparison of length of Hospital stay between those given unfractionated heparin and those given low molecular weight heparin.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients aged 18 years or more with suspected or proven DVT/PE whom the clinician intended to anticoagulate.
Exclusion Criteria:
DVT/PE severe enough to require thrombolysis or pulmonary embolectomy.
DVT/PE in the preceding 3 years.
Neoplasia diagnosed/treated within previous 3 years.
Pregnancy.
Known major thrombophilias.
Prolonged or continuous immobility or confinement to bed.
Previous allergy to heparin or warfarin.
Requirement for long-term anticoagulation.
Inability to give informed consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aziz Sheikh, MD,FRCGP
Organizational Affiliation
Research Committee of the British Thoracic Society
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Chest Medicine, Llandough Hospital
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF62 2XX
Country
United Kingdom
Facility Name
Department of Chest Medicine, Llandough Hospital,
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF64 2XX
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
17289685
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.
Results Reference
derived
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3 Months' Versus 6 Months' Anticoagulation in Patients With DVT and/or PE
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