NCT00720915

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 410 (actual)
• Sponsor: McMaster University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Deep Vein Thrombosis
• Pulmonary Embolism

Interventions

Type	Name	Description
OTHER	Discontinue anticoagulant therapy (Negative d-dimer)	Patients with negative d-dimer discontinue long-term anticoagulant therapy.
OTHER	Continue on anticoagulant therapy (positive d-dimer)	Patients with positive d-dimer continue or re-start on anticoagulant therapy

Timeline

• Start date: 2008-09-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2008-07-23
• Last updated: 2016-12-13

Locations

13 sites across 4 countries: United States, Canada, Ireland, United Kingdom