Idiopathic Venous Thromboembolism Clinical Trial
Official title:
REVERSEII: Validation of the "Men and HERDOO2"- A Clinical Decision Rule to Identify Patients With "Unprovoked" Venous Thromboembolism Who Can Discontinue Anticoagulants After 6 Months of Treatment.
The main objective of this study is to verify whether a new clinical decision rule identifying patients diagnosed with unprovoked blood clots who have a low risk of recurrence can safely stop oral anticoagulant therapy after 5-7 months of treatment.
Up to 50% of patients with a first episode of venous thromboembolism (VTE) have no
identifiable cause (i.e. are unprovoked VTEs). The risk of recurrent VTE in this large group
of patients with unprovoked VTE after 3-6 months of anticoagulant therapy is 5-10.8% in the
year following discontinuation of oral anticoagulant therapy. One in six to one in twenty
recurrences of a new VTE are fatal. Given the intermediate risks of recurrence in unselected
unprovoked VTE patients, clinicians do not have clear guidance on whether to continue or
discontinue anticoagulants in patients with unprovoked VTE. Recently attention has turned to
the concept of risk stratification to identify subgroups of patients with unprovoked VTE who
could safely discontinue oral anticoagulation therapy (OAT).
In the REVERSE I study, a clinical decision rule derivation study conducted from 2001 to
2006, we developed and internally validated the clinical decision rule "Men continue and HER
DOO2" that identifies patients with a first unprovoked VTE who likely have a low risk of
recurrent VTE and could safely discontinue OAT subsequent to 5-7 months of OAT. The present
study will evaluate if the "Men continue and HER DOO2" rule (comprised of gender, elevated
D-dimer levels, post-thrombotic signs, obesity, and older age) is safe, clinically useful,
and reproducible when prospectively implemented in multiple centers and a variety of
settings. If this clinical decision rule is validated, it will provide physicians with
important information to allow them to more confidently identify unprovoked VTE patients at
low risk of VTE recurrence who may not need to continue OAT.
;