Status:
COMPLETED
D-dimer to Select Patients With First Unprovoked Venous Thromboembolism Who Can Have Anticoagulants Stopped at 3 Months
Lead Sponsor:
McMaster University
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Deep Vein Thrombosis
Pulmonary Embolism
Eligibility:
All Genders
18-75 years
Phase:
NA
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 thro...
Eligibility Criteria
Inclusion
- Be \>= 18 years of age
- Have had ONE episode of unprovoked proximal DVT and/or PE
- Have completed 3 uninterrupted months of warfarin therapy (target INR of 2.0-3.0)
Exclusion
- Another indication for long-term anticoagulation (e.g., atrial fibrillation)
- 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)
- A vena caval filter
- Has had D-dimer testing performed within 2 months of potential enrollment other than for evaluation of suspected recurrent VTE that was not confirmed
- Has a life expectancy less than 5 years
- Is unable to attend follow-up visits because of geographic inaccessibility
- Is participating in a competing clinical investigation
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
410 Patients enrolled
Trial Details
Trial ID
NCT00720915
Start Date
September 1 2008
End Date
December 1 2016
Last Update
December 13 2016
Active Locations (13)
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1
Lombardi Cancer Center
Washington D.C., District of Columbia, United States, 20057
2
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
3
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
4
Beth Israel Deaconess Medical Centre
Boston, Massachusetts, United States, 02215