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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00365950
Other study ID # BTS DVT/PE Study
Secondary ID
Status Completed
Phase Phase 4
First received August 17, 2006
Last updated August 17, 2006
Start date September 1999
Est. completion date December 2003

Study information

Verified date January 2004
Source British Thoracic Society
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 2400
Est. completion date December 2003
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Duration of anticoagulation

Warfarin duration


Locations

Country Name City State
United Kingdom Department of Chest Medicine, Llandough Hospital Cardiff Wales
United Kingdom Department of Chest Medicine, Llandough Hospital, Cardiff Wales

Sponsors (1)

Lead Sponsor Collaborator
British Thoracic Society

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Death due to DVT/PE
Primary Failures of resolution, extension or recurrence of DVT and/or PE during and after treatment.
Primary Number of major haemorrhages.
Secondary Comparison of length of Hospital stay between those given unfractionated heparin and those given low molecular weight heparin.
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