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

Pulmonary Embolism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00365950
• Other study ID #: BTS DVT/PE Study
• 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
• 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

• Deep Vein Thrombosis
• Deep Vein Thrombosis With Pulmonary Embolism
• Embolism
• Pulmonary Embolism
• Thrombosis
• Venous Thrombosis

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.