Patients with a Venous Thromboembolism (VTE)
Conditions
Interventions
Trade Name: Warfarin sodium
Product Name: Warfarin Sodium
Product Code: BO1AA
Pharmaceutical Form: Tablet
Sponsors
The University of Birmingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: People aged 18 years or over with a diagnosis of first proximal unprovoked DVT or PE on treatment with anticoagulants; Patients who have completed 3 uninterrupted months of anticoagulant therapy. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: Patients under the age of 18 years Patients with another indication for long term warfarin therapy eg Atrial Fibrillation Patients with a diagnosis of first unprovoked proximal DVT or PE who are no longer on anticoagulation therapy Patients with a high incidence of bleeding as evidenced by any of the following: Patients with a previous episode of major bleeding where the cause was not effectively treated Known thrombocytopaenia with a platelet count of less than 120 x109 /L Known chronic renal failure with a creatinine of more than 150 µmols/L (1.7mg/dl) or eGFR less than 30 Known chronic liver disease with a total bilirubin of more than 25µmols/L (1.5mg/dl) Active peptic ulcer Patients requiring antiplatelet therapy (eg Aspirin and/or Clopidrogel) Patients with a vena cava filter in place Patients who have had a d–dimer test performed within 2 months of potential enrolment other than for evaluation for suspected recurrent VTE that was not confirmed Patients whose life expectancy less than 5 years Patients unable to attend follow up visits due to geographic inaccessibility Patients participating in a competing investigation Patients with known antiphospholipid syndrome Patients with known inherited protein C and/or protein S or antithrombin deficiency Patients with a diagnosis of active cancer Patients unwilling or unable to give consent Pregnant or breastfeeding women Women of child bearing potential (and men with partners of child bearing potential) will be required to practice effective contraception during the two years of their participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The overarching objective of this study is to improve the prevention and treatment of recurrent VTE and post-thrombotic syndrome in patients being treated for a first episode of a proximal (above the knee) unprovoked blood clot.;Secondary Objective: The secondary research objectives are to: Establish the preformance characteristics of D-dimer testing as a prediction tool for the recurrence of VTE in patients with a first unprovoked blood clot; Establish factors which contribute to the recurrence of VTE in patients with a first unprovoked blood clot; Determine the protective effect of prolonged warfarin therapy against post-thrombotic syndrome in patients with first unprovoked blood clot; Identify the cost-effectiveness and impact on patient quality of life of alternative approaches to delivery of care and treatment of patients with VTE.;Primary end point(s): The number of recurrent thrombotic events during the study. | — |
Countries
United Kingdom
Outcome results
None listed