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

Sponsor

British Thoracic Society (Other)

Overall Status

Completed

CT.gov ID

NCT00365950

Collaborator

(none)

2,400

Enrollment

Locations

Duration (Months)

1200

Patients Per Site

23.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

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

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 Design

Study Type:

Interventional

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

Study Start Date :

Sep 1, 1999

Study Completion Date :

Dec 1, 2003

Outcome Measures

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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Department of Chest Medicine, Llandough Hospital	Cardiff	Wales	United Kingdom	CF62 2XX
2	Department of Chest Medicine, Llandough Hospital,	Cardiff	Wales	United Kingdom	CF64 2XX