drugset / Trial / NCT00966290

Anticoagulant Clinics and Vitamin K Antagonists

NCT00966290

Phase 4 Completed 1006 enrolled University Hospital, Toulouse
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2003-02
Primary completion
2006-12
Completion
2006-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Fluindione Small molecule
Comparator Warfarin Small molecule
Comparator acenocoumarol Unknown