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OpenTrials
Completed

NCT Number: NCT00365950

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

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

Completed

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Key information

Conditions

Deep Vein Thrombosis Cardiovascular Diseases Deep Vein Thrombosis With Pulmonary Embolism Embolism Embolism and Thrombosis Lung Diseases Pulmonary Embolism Respiratory Tract Diseases Thrombosis Vascular Diseases Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Chest Medicine, Llandough Hospital, Cardiff, Wales, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Duration of anticoagulation

Drug

Warfarin duration

Drug

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.

Sponsors and collaborators

Lead sponsor

British Thoracic Society

Other

Registry information

Official study title

Clinical Trial of Two Durations of Warfarin Therapy in the Treatment of Deep Vein Thrombosis and/or Pulmonary Embolism

Important dates

Study start
1999
Study completion
2003
First posted
Aug 18, 2006
Registry last updated
Aug 18, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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