NCT00365950

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,400

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 1999

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1999

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2003

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

August 17, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 18, 2006

Completed
Last Updated

August 18, 2006

Status Verified

January 1, 2004

First QC Date

August 17, 2006

Last Update Submit

August 17, 2006

Conditions

Deep Vein ThrombosisPulmonary EmbolismDeep Vein Thrombosis With Pulmonary Embolism

Keywords

Duration of anticoagulationDeep vein thrombosis and/or pulmonary embolism

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

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

Interventions

Duration of anticoagulationDRUG
Warfarin durationDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18 years or more with suspected or proven DVT/PE whom the clinician intended to anticoagulate.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Chest Medicine, Llandough Hospital

Cardiff, Wales, CF62 2XX, United Kingdom

Location

Department of Chest Medicine, Llandough Hospital,

Cardiff, Wales, CF64 2XX, United Kingdom

Location

Related Publications (1)

  • Campbell IA, Bentley DP, Prescott RJ, Routledge PA, Shetty HG, Williamson IJ. Anticoagulation for three versus six months in patients with deep vein thrombosis or pulmonary embolism, or both: randomised trial. BMJ. 2007 Mar 31;334(7595):674. doi: 10.1136/bmj.39098.583356.55. Epub 2007 Feb 8.

    PMID: 17289685DERIVED

MeSH Terms

Conditions

Venous ThrombosisPulmonary Embolism

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesLung DiseasesRespiratory Tract DiseasesEmbolism

Study Officials

  • Aziz Sheikh, MD,FRCGP

    Research Committee of the British Thoracic Society

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 17, 2006

First Posted

August 18, 2006

Study Start

September 1, 1999

Study Completion

December 1, 2003

Last Updated

August 18, 2006

Record last verified: 2004-01

Locations

GB(2)