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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
McMaster University
ClinicalTrials.gov Identifier:
NCT00720915
First received: July 21, 2008
Last updated: June 20, 2013
Last verified: June 2013
  Purpose

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 Intervention
Deep Vein Thrombosis
Pulmonary Embolism
Other: Discontinue anticoagulant therapy (Negative d-dimer)
Other: Continue on anticoagulant therapy (positive d-dimer)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Suspected Recurrent DVT [ Time Frame: up to 7 years ] [ Designated as safety issue: Yes ]
  • Suspected (recurrent) pulmonary embolism [ Time Frame: up to 7 years ] [ Designated as safety issue: Yes ]
  • Bleeding [ Time Frame: up to 7 years ] [ Designated as safety issue: Yes ]
  • Death [ Time Frame: up to 7 years ] [ Designated as safety issue: Yes ]

Enrollment: 410
Study Start Date: September 2008
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00720915

Locations
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
Henderson Hospital
Hamilton, Ontario, Canada, L8V1C3
McMaster University
Hamilton, Ontario, Canada, L8N 3Z5
St. Joseph's Health Care Centre
Hamilton, Ontario, Canada, L8N 4A6
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2
Ireland
Limerick, Mid Western Regional Hospital
Limerick, Ireland
United Kingdom
Addenbrooke's Hospital
Cambridge, United Kingdom, B2 0QQ
Churchill Hospital
Oxford, United Kingdom, OX3 7LJ
Sponsors and Collaborators
McMaster University
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Clive Kearon, MB MRCP(I) FRCP(C) PhD McMaster University
  More Information

No publications provided

Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT00720915     History of Changes
Other Study ID Numbers: CTMG-2007-DODS
Study First Received: July 21, 2008
Last Updated: June 20, 2013
Health Authority: Canada: Health Canada
Canada: Ethics Review Committee

Keywords provided by McMaster University:
unprovoked deep vein thrombosis
unprovoked pulmonary embolism
anticoagulant therapy

Additional relevant MeSH terms:
Embolism
Venous Thromboembolism
Venous Thrombosis
Pulmonary Embolism
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thromboembolism
Lung Diseases
Respiratory Tract Diseases
Anticoagulants
Fibrin fragment D
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants

ClinicalTrials.gov processed this record on September 16, 2014