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CompletedNCT00720915DODSUpdated Dec 13, 2016

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

An interventional study of Discontinue anticoagulant therapy (Negative d-dimer) and Continue on anticoagulant therapy (positive d-dimer) in Deep Vein Thrombosis and Pulmonary Embolism, sponsored by McMaster University. Completed at 13 sites in 4 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-12-13.

Sponsored by McMaster University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
410
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Deep Vein Thrombosis
  • Pulmonary Embolism

Keywords

  • unprovoked deep vein thrombosis
  • unprovoked pulmonary embolism
  • anticoagulant therapy
03

In context

Venous Thrombosis

787 studies on the registry are indexed under Venous Thrombosis; 123 are open to participants now.

This study's enrollment of 410 is above the median of 131 across 463 interventional studies indexed under Venous Thrombosis.

Browse Venous Thrombosis studies →

Lead sponsor

McMaster University is the lead sponsor of 738 studies on the registry; 125 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.

Browse McMaster University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
410 participants (actual)

Study arms

  • Other
    No Anticoagulant Therapy

    No Anticoagulant Therapy

    Other: Discontinue anticoagulant therapy (Negative d-dimer)

  • Other
    Anticoagulant Therapy

    Continue on anticoagulant therapy

    Other: Continue on anticoagulant therapy (positive d-dimer)

Interventions

  • OtherDiscontinue anticoagulant therapy (Negative d-dimer)

    Patients with negative d-dimer discontinue long-term anticoagulant therapy.

  • OtherContinue on anticoagulant therapy (positive d-dimer)

    Patients with positive d-dimer continue or re-start on anticoagulant therapy

06

What researchers measure

Primary outcomes

  1. Suspected Recurrent DVT

    Time frame: up to 7 years

  2. Suspected (recurrent) pulmonary embolism

    Time frame: up to 7 years

  3. Bleeding

    Time frame: up to 7 years

  4. Death

    Time frame: up to 7 years

07

Study locations

13 sites
  • Lombardi Cancer Center
    Washington D.C., District of Columbia 20057, United States
  • University of Iowa Hospitals and Clinics
    Iowa City, Iowa 52242, United States
  • Brigham and Women's Hospital
    Boston, Massachusetts 02115, United States
  • Beth Israel Deaconess Medical Centre
    Boston, Massachusetts 02215, United States
  • Henry Ford Hospital
    Detroit, Michigan 48202, United States
  • UNC Thrombophilia Program
    Chapel Hill, North Carolina 27599-7035, United States
  • Intermountain Medical Centre
    Murray, Utah 84152, United States
  • Hamilton General Hospital
    Hamilton, Ontario L8L 2X2, Canada
  • McMaster University
    Hamilton, Ontario L8N 3Z5, Canada
  • St. Joseph's Health Care Centre
    Hamilton, Ontario L8N 4A6, Canada
  • Henderson Hospital
    Hamilton, Ontario L8V1C3, Canada
  • Limerick, Mid Western Regional Hospital
    Limerick, Ireland
  • Addenbrooke's Hospital
    Cambridge, B2 0QQ, United Kingdom
08

References and documents

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 31033194 ↗
  • 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. PubMed 29490924 ↗
  • 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. PubMed 25560712 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2008, a primary completion of Dec 2016 and a completion of Dec 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 21, 2008
First posted
Jul 23, 2008
Start
Sep 2008
Primary completionActual
Dec 2016
CompletionActual
Dec 2016
Last update
Dec 13, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 13, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00720915
Lead sponsor
McMaster University
Collaborators
Canadian Institutes of Health Research (CIHR)
Responsible party
Sponsor
First posted
Jul 23, 2008
Start date
Sep 2008
Primary completion
Dec 2016
Completion
Dec 2016
Last update
Dec 13, 2016

Study contacts

Clive Kearon, MB MRCP(I) FRCP(C) PhD
principal investigator · McMaster University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.

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