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Anticoagulant Clinics and Vitamin K Antagonists (COMPARE)

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

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
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 ]

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. ]

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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT00966290

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
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

Responsible Party: LLAU ME, University Hospital Toulouse Identifier: NCT00966290     History of Changes
Other Study ID Numbers: 0200301
PHRC 2002
Study First Received: August 21, 2009
Last Updated: August 25, 2009

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

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemostatic Disorders
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Vitamin K
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Growth Substances
Physiological Effects of Drugs processed this record on August 16, 2017