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

August 17, 2006 updated by: British Thoracic Society

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

2400

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
Comparison of length of Hospital stay between those given unfractionated heparin and those given low molecular weight heparin.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

British Thoracic Society

Investigators

  • Study Chair: Aziz Sheikh, MD,FRCGP, Research Committee of the British Thoracic Society

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 1999

Study Completion

December 1, 2003

Study Registration Dates

First Submitted

August 17, 2006

First Submitted That Met QC Criteria

August 17, 2006

First Posted (Estimate)

August 18, 2006

Study Record Updates

Last Update Posted (Estimate)

August 18, 2006

Last Update Submitted That Met QC Criteria

August 17, 2006

Last Verified

January 1, 2004

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BTS DVT/PE Study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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