Back to resultsD-dimer to Select Patients With First Unprovoked Venous Thromboembolism Who Can Have Anticoagulants Stopped at 3 Months (DODS)
Primary Purpose
Deep Vein Thrombosis, Pulmonary Embolism
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Discontinue anticoagulant therapy (Negative d-dimer)
Continue on anticoagulant therapy (positive d-dimer)
Sponsored by
About this trial
This is an interventional treatment trial for Deep Vein Thrombosis focused on measuring unprovoked deep vein thrombosis, unprovoked pulmonary embolism, anticoagulant therapy
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Lombardi Cancer Center
- University of Iowa Hospitals and Clinics
- Brigham and Women's Hospital
- Beth Israel Deaconess Medical Centre
- Henry Ford Hospital
- UNC Thrombophilia Program
- Intermountain Medical Centre
- Hamilton General Hospital
- McMaster University
- St. Joseph's Health Care Centre
- Henderson Hospital
- Limerick, Mid Western Regional Hospital
- Addenbrooke's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
No Anticoagulant Therapy
Anticoagulant Therapy
Arm Description
No Anticoagulant Therapy
Continue on anticoagulant therapy
Outcomes
Primary Outcome Measures
Suspected Recurrent DVT
Suspected (recurrent) pulmonary embolism
Bleeding
Death
Secondary Outcome Measures
Full Information
NCT ID
NCT00720915
First Posted
July 21, 2008
Last Updated
December 12, 2016
Sponsor
McMaster University
Collaborators
Canadian Institutes of Health Research (CIHR)
1. Study Identification
Unique Protocol Identification Number
NCT00720915
Brief Title
D-dimer to Select Patients With First Unprovoked Venous Thromboembolism Who Can Have Anticoagulants Stopped at 3 Months
Acronym
DODS
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 Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University
Collaborators
Canadian Institutes of Health Research (CIHR)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deep Vein Thrombosis, Pulmonary Embolism
Keywords
unprovoked deep vein thrombosis, unprovoked pulmonary embolism, anticoagulant therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
410 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No Anticoagulant Therapy
Arm Type
Other
Arm Description
No Anticoagulant Therapy
Arm Title
Anticoagulant Therapy
Arm Type
Other
Arm Description
Continue on anticoagulant therapy
Intervention Type
Other
Intervention Name(s)
Discontinue anticoagulant therapy (Negative d-dimer)
Intervention Description
Patients with negative d-dimer discontinue long-term anticoagulant therapy.
Intervention Type
Other
Intervention Name(s)
Continue on anticoagulant therapy (positive d-dimer)
Intervention Description
Patients with positive d-dimer continue or re-start on anticoagulant therapy
Primary Outcome Measure Information:
Title
Suspected Recurrent DVT
Time Frame
up to 7 years
Title
Suspected (recurrent) pulmonary embolism
Time Frame
up to 7 years
Title
Bleeding
Time Frame
up to 7 years
Title
Death
Time Frame
up to 7 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clive Kearon, MB MRCP(I) FRCP(C) PhD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lombardi Cancer Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20057
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Beth Israel Deaconess Medical Centre
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
UNC Thrombophilia Program
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7035
Country
United States
Facility Name
Intermountain Medical Centre
City
Murray
State/Province
Utah
ZIP/Postal Code
84152
Country
United States
Facility Name
Hamilton General Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Name
St. Joseph's Health Care Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Name
Henderson Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V1C3
Country
Canada
Facility Name
Limerick, Mid Western Regional Hospital
City
Limerick
Country
Ireland
Facility Name
Addenbrooke's Hospital
City
Cambridge
ZIP/Postal Code
B2 0QQ
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
31033194
Citation
Kearon C, Parpia S, Spencer FA, Schulman S, Stevens SM, Shah V, Bauer KA, Douketis JD, Lentz SR, Kessler CM, Connors JM, Ginsberg JS, Spadafora L, Julian JA. Long-term risk of recurrence in patients with a first unprovoked venous thromboembolism managed according to d-dimer results; A cohort study. J Thromb Haemost. 2019 Jul;17(7):1144-1152. doi: 10.1111/jth.14458. Epub 2019 May 20.
Results Reference
derived
PubMed Identifier
29490924
Citation
Kearon C, Parpia S, Spencer FA, Baglin T, Stevens SM, Bauer KA, Lentz SR, Kessler CM, Douketis JD, Moll S, Kaatz S, Schulman S, Connors JM, Ginsberg JS, Spadafora L, Bhagirath V, Liaw PC, Weitz JI, Julian JA. Antiphospholipid antibodies and recurrent thrombosis after a first unprovoked venous thromboembolism. Blood. 2018 May 10;131(19):2151-2160. doi: 10.1182/blood-2017-09-805689. Epub 2018 Feb 28.
Results Reference
derived
PubMed Identifier
25560712
Citation
Kearon C, Spencer FA, O'Keeffe D, Parpia S, Schulman S, Baglin T, Stevens SM, Kaatz S, Bauer KA, Douketis JD, Lentz SR, Kessler CM, Moll S, Connors JM, Ginsberg JS, Spadafora L, Julian JA; D-dimer Optimal Duration Study Investigators. D-dimer testing to select patients with a first unprovoked venous thromboembolism who can stop anticoagulant therapy: a cohort study. Ann Intern Med. 2015 Jan 6;162(1):27-34. doi: 10.7326/M14-1275.
Results Reference
derived
Learn more about this trial
D-dimer to Select Patients With First Unprovoked Venous Thromboembolism Who Can Have Anticoagulants Stopped at 3 Months
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