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

Pulmonary Embolism Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00720915
• Other study ID #: CTMG-2007-DODS
• Status: Completed
• Phase: N/A
• First received: July 21, 2008
• Last updated: December 12, 2016
• Start date: September 2008
• Est. completion date: December 2016

Study information

• Verified date: December 2016
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaCanada: Ethics Review Committee
• Study type: Interventional

Clinical 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 therapy and 1 month after stopping therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 410
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Embolism
• Pulmonary Embolism
• Thrombosis
• Venous Thromboembolism
• Venous Thrombosis

Intervention

Other:
• 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

Locations

Country	Name	City	State
Canada	Hamilton General Hospital	Hamilton	Ontario
Canada	Henderson Hospital	Hamilton	Ontario
Canada	McMaster University	Hamilton	Ontario
Canada	St. Joseph's Health Care Centre	Hamilton	Ontario
Ireland	Limerick, Mid Western Regional Hospital	Limerick
United Kingdom	Addenbrooke's Hospital	Cambridge
United States	Beth Israel Deaconess Medical Centre	Boston	Massachusetts
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	UNC Thrombophilia Program	Chapel Hill	North Carolina
United States	Henry Ford Hospital	Detroit	Michigan
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	Intermountain Medical Centre	Murray	Utah
United States	Lombardi Cancer Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	Canadian Institutes of Health Research (CIHR)

Countries where clinical trial is conducted

United States,  Canada,  Ireland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Suspected Recurrent DVT		up to 7 years	Yes
Primary	Suspected (recurrent) pulmonary embolism		up to 7 years	Yes
Primary	Bleeding		up to 7 years	Yes
Primary	Death		up to 7 years	Yes