Background: Whether the management of vitamin K antagonists (VKA) therapy by general
practitioners with the collaboration of anticoagulation clinics (ACC) provides better
clinical outcomes than that accomplished by general practitioners alone (usual care [UC]
management) is not clear.
Objectives: To compare ACC-based shared-care management with UC management of VKA therapy
with respect to clinical events.
Patients/Methods: Open, randomized, multicenter study in patients starting VKA therapy for at
least three months. The primary study outcome is a composite of confirmed symptomatic
thromboembolic or major bleeding events. All-cause mortality is a secondary outcome. All
outcomes are reviewed by a central, independent adjudication committee.
Phase:
Phase 4
Details
Lead Sponsor:
University Hospital, Toulouse
Treatments:
Acenocoumarol Anticoagulants Fluindione Phenindione Vitamin K Warfarin