D-dimer to Select Patients With First Unprovoked Venous Thromboembolism Who Can Have Anticoagulants Stopped at 3 Months
NCT ID: NCT00720915
Last Updated: 2016-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
410 participants
INTERVENTIONAL
2008-09-30
2016-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
No Anticoagulant Therapy
No Anticoagulant Therapy
Discontinue anticoagulant therapy (Negative d-dimer)
Patients with negative d-dimer discontinue long-term anticoagulant therapy.
Anticoagulant Therapy
Continue on anticoagulant therapy
Continue on anticoagulant therapy (positive d-dimer)
Patients with positive d-dimer continue or re-start on anticoagulant therapy
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Discontinue anticoagulant therapy (Negative d-dimer)
Patients with negative d-dimer discontinue long-term anticoagulant therapy.
Continue on anticoagulant therapy (positive d-dimer)
Patients with positive d-dimer continue or re-start on anticoagulant therapy
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Canadian Institutes of Health Research (CIHR)
OTHER_GOV
McMaster University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clive Kearon, MB MRCP(I) FRCP(C) PhD
Role: PRINCIPAL_INVESTIGATOR
McMaster University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CTMG-2007-DODS
Identifier Type: -
Identifier Source: org_study_id