Anticoagulant Clinics and Vitamin K Antagonists (COMPARE)

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT00966290
First received: August 21, 2009
Last updated: August 25, 2009
Last verified: August 2009
  Purpose

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.


Condition Intervention Phase
Blood Coagulation Disorders
Drug: Anticoagulant (warfarin, acenocoumarol, fluindione)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Anticoagulant Clinic-based Shared-care Versus Usual Cate Management of Vitamin K Antagonist Therapy : the Open, Randomized Multicenter Study

Resource links provided by NLM:


Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:
  • Each patient is contacted by standardized telephone calls every three months to determine whether he/she has experienced any thromboembolic or major bleeding complication, and to identify any interruptions in VKA treatment [ Time Frame: Patients are followed up for the duration of VKA treatment until 12 months or plus three days after treatment discontinuation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Quality of anticoagulation control evaluated in all patients with at least two INR measurements and assessed by determining (1) the percentage of INR within the target range, (2) the percentage of time during which the INR is within the target range [ Time Frame: Patients are followed up for the duration of VKA treatment until 12 months or plus three days after treatment discontinuation. ] [ Designated as safety issue: Yes ]

Enrollment: 1006
Study Start Date: February 2003
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ACC group
Anticoagulant clinic-based shared-care group
Drug: Anticoagulant (warfarin, acenocoumarol, fluindione)
Anticoagulant clinic based shared-care group
Other Name: Patients whose anticoagulation is managed by the general practitioner in collaboration with anticoagulant clinic
Active Comparator: UC group
Usual care group
Drug: Anticoagulant (warfarin, acenocoumarol, fluindione)
Usual care group
Other Name: Patients whose anticoagulation is managed by the general practitioner

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00966290

Locations
France
University Hospital
Brest, France, 29609
Louis Pasteur Hospital
Dole, France, 39100
University Hospital
Lille, France, 59037
Dupuytren University Hospital
Limoges, France, 87042
Bellevue University Hospital
Saint-Etienne, France, 42055
University Hospital
Strasbourg, France, 67091
Rangueil University Hospital
Toulouse, France, 31000
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: Henri Boccalon, MD University Hospital, Toulouse
Study Director: Alessandra BURA-RIVIERE, MD University Hospital, Toulouse
Study Director: Patrick Mismetti, MD University Hospital Saint-Etienne
Study Director: Bernard Boneu, MD University Hospital, Toulouse
  More Information

No publications provided

Responsible Party: LLAU ME, University Hospital Toulouse
ClinicalTrials.gov Identifier: NCT00966290     History of Changes
Other Study ID Numbers: 0200301, PHRC 2002
Study First Received: August 21, 2009
Last Updated: August 25, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Toulouse:
anticoagulants
management
anticoagulation clinics
randomized comparison

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemostatic Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Vascular Diseases
Acenocoumarol
Anticoagulants
Fluindione
Warfarin
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014