D-dimer to Select Patients With First Unprovoked Venous Thromboembolism Who Can Have Anticoagulants Stopped at 3 Months
NCT00720915 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 410
Last updated 2016-12-13
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.
Conditions
- Deep Vein Thrombosis
- Pulmonary Embolism
Interventions
- OTHER
-
Discontinue anticoagulant therapy (Negative d-dimer)
Patients with negative d-dimer discontinue long-term anticoagulant therapy.
- OTHER
-
Continue on anticoagulant therapy (positive d-dimer)
Patients with positive d-dimer continue or re-start on anticoagulant therapy
Sponsors & Collaborators
-
Canadian Institutes of Health Research (CIHR)
collaborator OTHER_GOV - lead OTHER
Principal Investigators
-
Clive Kearon, MB MRCP(I) FRCP(C) PhD · McMaster University
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-09-30
- Primary Completion
- 2016-12-31
- Completion
- 2016-12-31
Countries
- United States
- Canada
- Ireland
- United Kingdom
Study Locations
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