Deep Vein ThrombosisDODSNCT00720915
D-dimer to Select Patients With First Unprovoked Venous Thromboembolism Who Can Have Anticoagulants Stopped at 3 Months
A study testing Discontinue anticoagulant therapy (Negative d-dimer) and Continue on anticoagulant therapy (positive d-dimer) in people with Deep Vein Thrombosis and Pulmonary Embolism, run by McMaster University at 13 sites in 4 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Deep Vein Thrombosis, Pulmonary Embolism
- What is being tested?
- Discontinue anticoagulant therapy (Negative d-dimer) and Continue on anticoagulant therapy (positive d-dimer)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 410 participants
- Where
- 13 sitesin 4 countries
- Study dates
- Sep 2008to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 15Show fewer
- 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
Trial locations and contacts
13 sites in 4 countries.
13 sites in 4 countries
United States7 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Centre
Boston, Massachusetts, 02215
UNC Thrombophilia Program
Chapel Hill, North Carolina, 27599-7035
Henry Ford Hospital
Detroit, Michigan, 48202
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Intermountain Medical Centre
Murray, Utah, 84152
Lombardi Cancer Center
Washington D.C., District of Columbia, 20057
Canada4 sites
Hamilton General Hospital
Hamilton, Ontario, L8L 2X2
McMaster University
Hamilton, Ontario, L8N 3Z5
St. Joseph's Health Care Centre
Hamilton, Ontario, L8N 4A6
Henderson Hospital
Hamilton, Ontario, L8V1C3
About this study
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
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.
- Conditions
- Deep Vein Thrombosis, Pulmonary Embolism
- Being tested
- Discontinue anticoagulant therapy (Negative d-dimer), Continue on anticoagulant therapy (positive d-dimer)
- Keywords
- unprovoked deep vein thrombosis, unprovoked pulmonary embolism, anticoagulant therapy
- Medical subject headings
- Venous Thrombosis, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Discontinue anticoagulant therapy (Negative d-dimer)Other
Patients with negative d-dimer discontinue long-term anticoagulant therapy.
Continue on anticoagulant therapy (positive d-dimer)Other
Patients with positive d-dimer continue or re-start on anticoagulant therapy
| Study group | Role | What they receive |
|---|---|---|
| No Anticoagulant Therapy | Other | No Anticoagulant Therapy Receives: Other: Discontinue anticoagulant therapy (Negative d-dimer) |
| Anticoagulant Therapy | Other | Continue on anticoagulant therapy Receives: Other: Continue on anticoagulant therapy (positive d-dimer) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suspected Recurrent DVT
Measured: up to 7 years
Suspected (recurrent) pulmonary embolism
Measured: up to 7 years
Bleeding
Measured: up to 7 years
Death
Measured: up to 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2008 (estimated)
- Study startSep 2008
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Deep Vein ThrombosisStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 410 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Clive Kearon, MB MRCP(I) FRCP(C) PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00720915
- Sponsor's protocol ID
- CTMG-2007-DODS
- Acronym
- DODS
- Status last verified
- Dec 2016
- First submitted
- 21 Jul 2008
- Last updated
- 13 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 31033194Kearon 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.
PubMed 29490924Kearon 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.
PubMed 25560712
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00720915
- Acronym / sponsor ID
- DODS / CTMG-2007-DODS
- Conditions
- Deep Vein Thrombosis, Pulmonary Embolism
- Keywords
- unprovoked deep vein thrombosis, unprovoked pulmonary embolism, anticoagulant therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 410 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Sep 2008
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 23 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Anticoagulant Therapy | Other | Other: Discontinue anticoagulant therapy (Negative d-dimer)No Anticoagulant Therapy |
| Anticoagulant Therapy | Other | Other: Continue on anticoagulant therapy (positive d-dimer)Continue on anticoagulant therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (15 listed)
- Another indication for long-term anticoagulation (e.g., atrial fibrillation)
- A high risk of bleeding as evidenced by any of the following:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Discontinue anticoagulant therapy (Negative d-dimer)Patients with negative d-dimer discontinue long-term anticoagulant therapy. | Other | No Anticoagulant Therapy |
| Continue on anticoagulant therapy (positive d-dimer)Patients with positive d-dimer continue or re-start on anticoagulant therapy | Other | Anticoagulant Therapy |
Primary outcome
Suspected Recurrent DVT
Time frame: up to 7 years
Suspected (recurrent) pulmonary embolism
Time frame: up to 7 years
Bleeding
Time frame: up to 7 years
Death
Time frame: up to 7 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2016.
- Derived from this study: PubMed 31033194Kearon 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.
- Derived from this study: PubMed 29490924Kearon 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.
- Derived from this study: PubMed 25560712Kearon 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clive Kearon, MB MRCP(I) FRCP(C) PhD principal investigator
McMaster University
13 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Discontinue anticoagulant therapy (Negative d-dimer) and Continue on anticoagulant therapy (positive d-dimer) in people with Deep Vein Thrombosis and Pulmonary Embolism, run by McMaster University at 13 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Canada, Ireland, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Suspected Recurrent DVT (time frame: up to 7 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00720915, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2016.