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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00365950
First Posted: August 18, 2006
Last Update Posted: August 18, 2006
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.
Information provided by:
British Thoracic Society
  Purpose
To determine whether 3 months' anticoagulation is as good as or better than 6 months' for the treatment of DVT/PE

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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by British Thoracic Society:

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.

Estimated Enrollment: 2400
Study Start Date: September 1999
Estimated Study Completion Date: December 2003
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00365950


Locations
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
Investigators
Study Chair: Aziz Sheikh, MD,FRCGP Research Committee of the British Thoracic Society
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00365950     History of Changes
Other Study ID Numbers: BTS DVT/PE Study
First Submitted: August 17, 2006
First Posted: August 18, 2006
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:
Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Embolism
Pulmonary Embolism
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Warfarin
Anticoagulants