Deep Vein ThrombosisPhase 4NCT00365950
3 Months' Versus 6 Months' Anticoagulation in Patients With DVT and/or PE
A Phase 4 study testing Duration of anticoagulation and Warfarin duration in people with Deep Vein Thrombosis and Pulmonary Embolism, run by British Thoracic Society at 2 sites in United Kingdom.
Trial summary
To determine whether 3 months' anticoagulation is as good as or better than 6 months' for the treatment of DVT/PE Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deep Vein Thrombosis, Pulmonary Embolism, Deep Vein Thrombosis With Pulmonary Embolism
- What is being tested?
- Duration of anticoagulation and Warfarin duration
- How many people
- 2,400 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Sep 1999to Dec 2003
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 years or more with suspected or proven DVT/PE whom the clinician intended to anticoagulate.
Who cannot join
- 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.
Show all 9Show fewer
- Previous allergy to heparin or warfarin.
- Requirement for long-term anticoagulation.
- Inability to give informed consent.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Department of Chest Medicine, Llandough Hospital
Cardiff, Wales, CF62 2XX
Department of Chest Medicine, Llandough Hospital,
Cardiff, Wales, CF64 2XX
About this study
Official title: Clinical Trial of Two Durations of Warfarin Therapy in the Treatment of Deep Vein Thrombosis and/or Pulmonary Embolism
To determine whether 3 months' anticoagulation is as good as or better than 6 months' for the treatment of DVT/PE
Read the 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.
- Being tested
- Duration of anticoagulation, Warfarin duration
- Keywords
- Duration of anticoagulation, Deep vein thrombosis and/or pulmonary embolism
- Medical subject headings
- Venous Thrombosis, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duration of anticoagulationDrug
Warfarin durationDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (1)
Comparison of length of Hospital stay between those given unfractionated heparin and those given low molecular weight heparin.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2006 (estimated)
- Study startSep 1999
- Study completionDec 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Deep Vein ThrombosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,400 participants
Sponsor and investigators
- Lead sponsor
- British Thoracic Society
- Sponsor type
- University, hospital or other
- Investigators
- Aziz Sheikh, MD,FRCGP, Study chair, Research Committee of the British Thoracic Society
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00365950
- Sponsor's protocol ID
- BTS DVT/PE Study
- Status last verified
- Jan 2004
- First submitted
- 17 Aug 2006
- Last updated
- 18 Aug 2006
- Results posted
- No
Publications
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.
PubMed 17289685
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Two Durations of Warfarin Therapy in the Treatment of Deep Vein Thrombosis and/or Pulmonary Embolism
- ClinicalTrials.gov ID
- NCT00365950
- Acronym / sponsor ID
- BTS DVT/PE Study
- Keywords
- Duration of anticoagulation, Deep vein thrombosis and/or pulmonary embolism
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,400 participants
- Lead sponsor
- British Thoracic SocietyUniversity, hospital or other
- Study start
- Sep 1999
- Study completion
- Dec 2003
- First posted
- 18 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 18 years or more with suspected or proven DVT/PE whom the clinician intended to anticoagulate.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Duration of anticoagulation | Drug | – |
| Warfarin duration | Drug | – |
Primary outcome
Death due to DVT/PE
Failures of resolution, extension or recurrence of DVT and/or PE during and after treatment.
Number of major haemorrhages.
1 secondary outcome
Comparison of length of Hospital stay between those given unfractionated heparin and those given low molecular weight heparin.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2006.
- Derived from this study: PubMed 17289685Campbell 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aziz Sheikh, MD,FRCGP study chair
Research Committee of the British Thoracic Society
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Duration of anticoagulation and Warfarin duration in people with Deep Vein Thrombosis and Pulmonary Embolism, run by British Thoracic Society at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death due to DVT/PE. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00365950, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2006.