3 Months' Versus 6 Months' Anticoagulation in Patients Wi... | NCT00365950

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

NCT00365950

Sponsor

British Thoracic Society

Status

Completed

Last Update Posted

Aug 18, 2006Estimated

Enrollment

2,400

Phase

Phase 4

Conditions

Deep Vein Thrombosis
Pulmonary Embolism
Deep Vein Thrombosis With Pulmonary Embolism

Interventions

Duration of anticoagulation
Warfarin duration

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2004

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1999

Primary Completion Date

Not provided

Completion Date

Dec 2003

First Submitted Date

Aug 17, 2006

First Submission Date that Met QC Criteria

Aug 17, 2006

First Posted Date

Aug 18, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 17, 2006

Last Update Posted Date

Aug 18, 2006Estimated

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2,400

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Aziz Sheikh, MD,FRCGP	Research Committee of the British Thoracic Society	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Chest Medicine, Llandough Hospital		Cardiff	Wales	CF62 2XX	United Kingdom
Department of Chest Medicine, Llandough Hospital,

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17289685	Derived	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.

ID	Term
D020246	Venous Thrombosis
D011655	Pulmonary Embolism

ID	Term
D013927	Thrombosis
D016769	Embolism and Thrombosis
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Name	Type	Description	Arm Group Labels	Other Names
Duration of anticoagulation	Drug
Warfarin duration	Drug