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CompletedNCT00365950Updated Aug 18, 2006

3 Months' Versus 6 Months' Anticoagulation in Patients With DVT and/or PE

A Phase 4 interventional study of Duration of anticoagulation and Warfarin duration in Deep Vein Thrombosis, Pulmonary Embolism and Deep Vein Thrombosis With Pulmonary Embolism, sponsored by British Thoracic Society. Completed at 2 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2006-08-18.

Sponsored by British Thoracic Society · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
2,400
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Deep Vein Thrombosis
  • Pulmonary Embolism
  • Deep Vein Thrombosis With Pulmonary Embolism

Keywords

  • Duration of anticoagulation
  • Deep vein thrombosis and/or pulmonary embolism
03

In context

Pulmonary Embolism

739 studies on the registry are indexed under Pulmonary Embolism; 159 are open to participants now.

This study's enrollment of 2,400 is above the median of 150 across 381 interventional studies indexed under Pulmonary Embolism.

Browse Pulmonary Embolism studies →

Lead sponsor

British Thoracic Society is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients aged 18 years or more with suspected or proven DVT/PE whom the clinician intended to anticoagulate.

Exclusion criteria

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
2,400 participants

Interventions

  • DrugDuration of anticoagulation
  • DrugWarfarin duration
06

What researchers measure

Primary outcomes

  1. Death due to DVT/PE

  2. Failures of resolution, extension or recurrence of DVT and/or PE during and after treatment.

  3. 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.

07

Study locations

2 sites
  • Department of Chest Medicine, Llandough Hospital
    Cardiff, Wales CF62 2XX, United Kingdom
  • Department of Chest Medicine, Llandough Hospital,
    Cardiff, Wales CF64 2XX, United Kingdom
08

References and documents

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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 18, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00365950
Lead sponsor
British Thoracic Society
First posted
Aug 18, 2006
Start date
Sep 1999
Completion
Dec 2003
Last update
Aug 18, 2006

Study contacts

Aziz Sheikh, MD,FRCGP
study chair · Research Committee of the British Thoracic Society
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2004. You cannot join it, but the record below documents what was studied.

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