Clinical trial NCT00720915: D-dimer to Select Patients With First Unprovoked Venous Thromboembolism Who Can Have Anticoagulants Stopped at 3 Months
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
Overall status: COMPLETED
Phase: NA
Conditions: Deep Vein Thrombosis
Pulmonary Embolism
Keywords: unprovoked deep vein thrombosis
unprovoked pulmonary embolism
anticoagulant therapy
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2008-07-23
Enrollment: 410
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Suspected Recurrent DVT
timeFrame: up to 7 years
measure: Suspected (recurrent) pulmonary embolism
timeFrame: up to 7 years
measure: Bleeding
timeFrame: up to 7 years
measure: Death
timeFrame: up to 7 years
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Lombardi Cancer Center
state: District of Columbia
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Centre
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Chapel Hill
country: United States
facility: UNC Thrombophilia Program
state: North Carolina
city: Murray
country: United States
facility: Intermountain Medical Centre
state: Utah
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
city: Hamilton
country: Canada
facility: St. Joseph's Health Care Centre
state: Ontario
city: Hamilton
country: Canada
facility: Henderson Hospital
state: Ontario
city: Limerick
country: Ireland
facility: Limerick, Mid Western Regional Hospital
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
Study officials:
affiliation: McMaster University
name: Clive Kearon, MB MRCP(I) FRCP(C) PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.