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

McMaster University

Status: Completed

Conditions: Pulmonary Embolism; Deep Vein Thrombosis

Treatments: Other: Discontinue anticoagulant therapy (Negative d-dimer); Other: Continue on anticoagulant therapy (positive d-dimer)

Study type: Interventional

Funder types: Other

Identifiers

NCT00720915

CTMG-2007-DODS

Details and patient eligibility

About

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.

Enrollment: 410 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

410 participants in 2 patient groups

No Anticoagulant Therapy

Other group

Description:

No Anticoagulant Therapy

Treatment:

Other: Discontinue anticoagulant therapy (Negative d-dimer)

Anticoagulant Therapy

Other group

Description:

Continue on anticoagulant therapy

Treatment:

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