ExACT Extended anticoagulation treatment for VTE: a randomised trial
Research type
Research Study
Full title
A randomised controlled trial of extended warfarin treatment versus routine warfarin treatment for the prevention of recurrent venous thromboembolism and post thrombotic syndrome in patients being treated for a first episode of unprovoked VTE
IRAS ID
47947
Contact name
David Fitzmaurice
Contact email
Sponsor organisation
The University of Birmingham
Eudract number
2010-022119-20
ISRCTN Number
ISRCTN73819751
Duration of Study in the UK
5 years, 0 months, 0 days
Research summary
Venous thromboembolism (VTE) is the umbrella term given to blood clots in the lungs and legs. It is a common condition associated with high morbidity and mortality.
After having a clot, a few people are at very high risk of having another one, and there is a slight risk of a clot in the lungs leading to serious lung damage, or even death. In the longer term, patients may also develop problems with circulation in their legs, known as post-thrombotic syndrome. At present, treatment with warfarin, a blood thinning drug, is generally stopped after 3 to 6 months, because many patients will not develop another clot and warfarin can cause problems, especially with bleeding. However, recurrence after first unprovoked DVT can be up to 10% per annum following treatment cessation irrespective of the duration of anticoagulation therapy. Clearly some patients need long-term anticoagulation, but we are currently unable to identify this population.This study aims to: i) identify patients at highest risk of having a second clot from D-dimer tests and other factors; ii) see if extended treatment can prevent recurrent clots; iii) identify patients at highest risk of developing post-thrombotic syndrome; iv) identify the most cost-effective means of both preventing and treating clots; v) determine patient preferences and utilities with regard to extended warfarin.
Patients from primary and secondary care clinics aged 18 years or over diagnosed with first proximal unprovoked Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE) will be randomly allocated to continue warfarin for another 2 years or to stop warfarin as planned. All patients will be reviewed at 6 monthly reviews to assess D-dimer levels, VTE recurrence and evidence of post thrombotic syndrome. They will also be asked to complete quality of life questionnaires at each 6 monthly review.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
10/H0405/70
Date of REC Opinion
21 Oct 2010
REC opinion
Further Information Favourable Opinion