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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00365950
Recruitment Status : Completed
First Posted : August 18, 2006
Last Update Posted : August 18, 2006
Information provided by:
British Thoracic Society

Brief Summary:
To determine whether 3 months' anticoagulation is as good as or better than 6 months' for the treatment of DVT/PE

Condition or disease Intervention/treatment Phase
Deep Vein Thrombosis Pulmonary Embolism Deep Vein Thrombosis With Pulmonary Embolism Drug: Duration of anticoagulation Drug: Warfarin duration Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 2400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Trial of Two Durations of Warfarin Therapy in the Treatment of Deep Vein Thrombosis and/or Pulmonary Embolism
Study Start Date : September 1999
Study Completion Date : December 2003

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  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 Outcome Measures :
  1. Comparison of length of Hospital stay between those given unfractionated heparin and those given low molecular weight heparin.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00365950

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United Kingdom
Department of Chest Medicine, Llandough Hospital
Cardiff, Wales, United Kingdom, CF62 2XX
Department of Chest Medicine, Llandough Hospital,
Cardiff, Wales, United Kingdom, CF64 2XX
Sponsors and Collaborators
British Thoracic Society
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Study Chair: Aziz Sheikh, MD,FRCGP Research Committee of the British Thoracic Society

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00365950    
Other Study ID Numbers: BTS DVT/PE Study
First Posted: August 18, 2006    Key Record Dates
Last Update Posted: August 18, 2006
Last Verified: January 2004
Keywords provided by British Thoracic Society:
Duration of anticoagulation
Deep vein thrombosis and/or pulmonary embolism
Additional relevant MeSH terms:
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Pulmonary Embolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases