Deep Vein Thrombosis, Pulmonary Embolism
Conditions
Keywords
unprovoked deep vein thrombosis, unprovoked pulmonary embolism, anticoagulant therapy
Brief summary
The purpose of this study is to determine if the risk of recurrent venous thromboembolism (VTE) after stopping therapy is low and acceptable in patients with a first unprovoked proximal deep vein thrombosis (DVT) or pulmonary embolism (PE) who have completed 3 months of therapy and who have a negative D-dimer test on therapy and 1 month after stopping therapy.
Interventions
OTHERDiscontinue anticoagulant therapy (Negative d-dimer)
Patients with negative d-dimer discontinue long-term anticoagulant therapy.
OTHERContinue on anticoagulant therapy (positive d-dimer)
Patients with positive d-dimer continue or re-start on anticoagulant therapy
Sponsors
Canadian Institutes of Health Research (CIHR)
McMaster University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Be \>= 18 years of age 2. Have had ONE episode of unprovoked proximal DVT and/or PE 3. Have completed 3 uninterrupted months of warfarin therapy (target INR of 2.0-3.0)
Exclusion criteria
1. Another indication for long-term anticoagulation (e.g., atrial fibrillation) 2. A high risk of bleeding as evidenced by any of the following: * Age greater than 75 years * Previous episode of major bleeding where the cause was not effectively treated * Known chronic thrombocytopenia with a platelet count of less than 120,000 x 10\^9 /L * Known chronic renal impairment with a creatinine of more than 150 mumols /litre (1.7 mg/dl) * Known chronic liver disease with a total bilirubin of more than 25 mumols /litre (1.5 mg/dl) * Active peptic ulcer disease * Poor compliance with, or control of, anticoagulant therapy during initial treatment * Requires dual antiplatelet therapy (e.g. aspirin and clopidogrel) 3. A vena caval filter 4. Has had D-dimer testing performed within 2 months of potential enrollment other than for evaluation of suspected recurrent VTE that was not confirmed 5. Has a life expectancy less than 5 years 6. Is unable to attend follow-up visits because of geographic inaccessibility 7. Is participating in a competing clinical investigation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Suspected (recurrent) pulmonary embolism | up to 7 years |
| Bleeding | up to 7 years |
| Death | up to 7 years |
| Suspected Recurrent DVT | up to 7 years |
Countries
Canada, Ireland, United Kingdom, United States
Outcome results
None listed