Overview

Anticoagulant Clinics and Vitamin K Antagonists

Status:
Completed

Trial end date:
2006-12-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

University Hospital, Toulouse

Treatments:

Acenocoumarol
Anticoagulants
Fluindione
Phenindione
Vitamin K
Warfarin

Criteria

Inclusion Criteria:

- inpatients and outpatients who are starting a course of VKA therapy scheduled to last
for at least three months

Exclusion Criteria:

- life expectancy of less than three months

- contraindication to anticoagulant therapy because of bleeding risk

- refusal of his/her general practitioner to participate in the study

- no general practitioner likelihood of poor follow-up or poor compliance (e.g.,
patients unable to care for themselves, lacking adequate home support or unwilling to
comply with the treatment care plan)