drugset / Trial / NCT00428441

D-dimer to Predict Recurrence in Patients With Multiple Episodes of Venous Thromboembolism

NCT00428441

Terminated 73 enrolled University of Insubria
Non-randomizedSingle-groupOpen-labelTreatment

Summary

Optimal duration of oral anticoagulant therapy in patients with recurrent episodes of venous thromboembolism (VTE) is a matter of debate and recommendations are based on inadequate evidence. More than 12 months of treatment are currently recommended, and the grade of recommendation is low. The PROLONG study has recently evaluated the predictive role of D-dimer measurement after withholding oral anticoagulant treatment in patients with a first episode of VTE. Patients with a positive D-dimer had a significantly higher incidence of VTE recurrences than patients with a negative D-dimer and required resumption of the antithrombotic treatment. Based on the results of this and of previous cohort studies, it appears safe to withhold treatment in patients with negative D-dimer values and to continue treatment in patients with altered D-dimer levels. Aim of this study is therefore to assess the negative predictive value of D-dimer also in patients with recurrent VTE and to evaluate the clinical utility of this approach in this patient setting.

Timeline

Start
2007-05
Primary completion
2010-06
Completion
2011-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Warfarin Small molecule