D-dimer to Select Patients With First Unprovoked Venous Thromboembolism Who Can Have Anticoagulants Stopped at 3 Months

Completed · Not applicable

Conditions studied: Deep Vein Thrombosis, Pulmonary Embolism

In brief

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.

Key facts

Study ID

NCT00720915

Run by

McMaster University

People needed

410

Starts

2008-09-01

Expected to finish

2016-12-01

Last updated by the study team

2016-12-13

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Lombardi Cancer Center — Washington D.C., District of Columbia, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Centre — Boston, Massachusetts, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• UNC Thrombophilia Program — Chapel Hill, North Carolina, United States
• Intermountain Medical Centre — Murray, Utah, United States
• Hamilton General Hospital — Hamilton, Ontario, Canada
• McMaster University — Hamilton, Ontario, Canada
• St. Joseph's Health Care Centre — Hamilton, Ontario, Canada
• Henderson Hospital — Hamilton, Ontario, Canada
• Limerick, Mid Western Regional Hospital — Limerick, Ireland
• Addenbrooke's Hospital — Cambridge, United Kingdom

Full record on ClinicalTrials.gov

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