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Anticoagulant Clinics and Vitamin K Antagonists

NCT00966290 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1006

Last updated 2009-08-26

No results posted yet for this study

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.

Conditions

  • Blood Coagulation Disorders

Interventions

DRUG

Anticoagulant (warfarin, acenocoumarol, fluindione)

Anticoagulant clinic based shared-care group

DRUG

Anticoagulant (warfarin, acenocoumarol, fluindione)

Usual care group

Sponsors & Collaborators

  • University Hospital, Toulouse

    lead OTHER

Principal Investigators

  • Henri Boccalon, MD · University Hospital, Toulouse

  • Alessandra BURA-RIVIERE, MD · University Hospital, Toulouse

  • Patrick Mismetti, MD · University Hospital Saint-Etienne

  • Bernard Boneu, MD · University Hospital, Toulouse

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-02-28
Primary Completion
2006-12-31
Completion
2006-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00966290 on ClinicalTrials.gov