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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

2400 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-09-30

Study Completion Date

2003-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Deep Vein Thrombosis Pulmonary Embolism Deep Vein Thrombosis With Pulmonary Embolism

Keywords

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Duration of anticoagulation Deep vein thrombosis and/or pulmonary embolism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Duration of anticoagulation

Intervention Type DRUG

Warfarin duration

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Aziz Sheikh, MD,FRCGP

Role: STUDY_CHAIR

Research Committee of the British Thoracic Society

Locations

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Department of Chest Medicine, Llandough Hospital

Cardiff, Wales, United Kingdom

Site Status

Department of Chest Medicine, Llandough Hospital,

Cardiff, Wales, United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED

PMID: 17289685 (View on PubMed)

Other Identifiers

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BTS DVT/PE Study

Identifier Type: -

Identifier Source: org_study_id