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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00365950

Enrollment

2400

Registered

2006-08-18

Start date

1999-09-30

Completion date

2003-12-31

Last updated

2006-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deep Vein Thrombosis, Deep Vein Thrombosis With Pulmonary Embolism, Pulmonary Embolism

Keywords

Duration of anticoagulation, Deep vein thrombosis and/or pulmonary embolism

Brief summary

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

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.

Interventions

DRUGDuration of anticoagulation

DRUGWarfarin duration

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
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

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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 8, 2026