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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00720915
Recruitment Status : Completed
First Posted : July 23, 2008
Last Update Posted : December 13, 2016
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
McMaster University

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.

Condition or disease Intervention/treatment Phase
Deep Vein Thrombosis Pulmonary Embolism Other: Discontinue anticoagulant therapy (Negative d-dimer) Other: Continue on anticoagulant therapy (positive d-dimer) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 410 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Cohort Study to Test That There is a Low Risk of Recurrent VTE in Patients With a First Episode of Unprovoked VTE Who Stop Anticoagulant Therapy After 3 Months of Treatment in Response to Negative D-dimer Testing
Study Start Date : September 2008
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Anticoagulant Therapy
No Anticoagulant Therapy
Other: Discontinue anticoagulant therapy (Negative d-dimer)
Patients with negative d-dimer discontinue long-term anticoagulant therapy.

Anticoagulant Therapy
Continue on anticoagulant therapy
Other: Continue on anticoagulant therapy (positive d-dimer)
Patients with positive d-dimer continue or re-start on anticoagulant therapy

Primary Outcome Measures :
  1. Suspected Recurrent DVT [ Time Frame: up to 7 years ]
  2. Suspected (recurrent) pulmonary embolism [ Time Frame: up to 7 years ]
  3. Bleeding [ Time Frame: up to 7 years ]
  4. Death [ Time Frame: up to 7 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00720915

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United States, District of Columbia
Lombardi Cancer Center
Washington, District of Columbia, United States, 20057
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Centre
Boston, Massachusetts, United States, 02215
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, North Carolina
UNC Thrombophilia Program
Chapel Hill, North Carolina, United States, 27599-7035
United States, Utah
Intermountain Medical Centre
Murray, Utah, United States, 84152
Canada, Ontario
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2
McMaster University
Hamilton, Ontario, Canada, L8N 3Z5
St. Joseph's Health Care Centre
Hamilton, Ontario, Canada, L8N 4A6
Henderson Hospital
Hamilton, Ontario, Canada, L8V1C3
Limerick, Mid Western Regional Hospital
Limerick, Ireland
United Kingdom
Addenbrooke's Hospital
Cambridge, United Kingdom, B2 0QQ
Sponsors and Collaborators
McMaster University
Canadian Institutes of Health Research (CIHR)
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Principal Investigator: Clive Kearon, MB MRCP(I) FRCP(C) PhD McMaster University
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: McMaster University Identifier: NCT00720915    
Other Study ID Numbers: CTMG-2007-DODS
First Posted: July 23, 2008    Key Record Dates
Last Update Posted: December 13, 2016
Last Verified: December 2016
Keywords provided by McMaster University:
unprovoked deep vein thrombosis
unprovoked pulmonary embolism
anticoagulant therapy
Additional relevant MeSH terms:
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Pulmonary Embolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Fibrin fragment D
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action