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

This study has been completed.
Sponsor:
Information provided by:
British Thoracic Society
ClinicalTrials.gov Identifier:
NCT00365950
First received: August 17, 2006
Last updated: NA
Last verified: January 2004
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by British Thoracic Society

Additional 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
Study First Received: August 17, 2006
Last Updated: August 17, 2006
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by British Thoracic Society:
Duration of anticoagulation
Deep vein thrombosis and/or pulmonary embolism

Additional relevant MeSH terms:
Embolism
Pulmonary Embolism
Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
 Lung Diseases
Respiratory Tract Diseases
Warfarin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013