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

December 12, 2016 updated by: McMaster University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

410

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • McMaster University
      • Hamilton, Ontario, Canada, L8L 2X2
        • Hamilton General Hospital
      • Hamilton, Ontario, Canada, L8N 4A6
        • St. Joseph's Health Care Centre
      • Hamilton, Ontario, Canada, L8V1C3
        • Henderson Hospital
  • Ireland
      • Limerick, Ireland
        • Limerick, Mid Western Regional Hospital
  • United Kingdom
      • Cambridge, United Kingdom, B2 0QQ
        • Addenbrooke's Hospital
  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20057
        • Lombardi Cancer Center
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Centre
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7035
        • UNC Thrombophilia Program
    • Utah
      • Murray, Utah, United States, 84152
        • Intermountain Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Suspected Recurrent DVT
Time Frame: up to 7 years
up to 7 years
Suspected (recurrent) pulmonary embolism
Time Frame: up to 7 years
up to 7 years
Bleeding
Time Frame: up to 7 years
up to 7 years
Death
Time Frame: up to 7 years
up to 7 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Collaborators

Canadian Institutes of Health Research (CIHR)

Investigators

  • Principal Investigator: Clive Kearon, MB MRCP(I) FRCP(C) PhD, McMaster University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

July 21, 2008

First Submitted That Met QC Criteria

July 21, 2008

First Posted (Estimate)

July 23, 2008

Study Record Updates

Last Update Posted (Estimate)

December 13, 2016

Last Update Submitted That Met QC Criteria

December 12, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTMG-2007-DODS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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