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Trial record 33 of 169 for:    warfarin AND Vitamin K

Anticoagulant Clinics and Vitamin K Antagonists (COMPARE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00966290
Recruitment Status : Completed
First Posted : August 26, 2009
Last Update Posted : August 26, 2009
Information provided by:
University Hospital, Toulouse

Brief 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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1006 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : February 2003
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. 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. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00966290

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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
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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
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Responsible Party: LLAU ME, University Hospital Toulouse Identifier: NCT00966290    
Other Study ID Numbers: 0200301
PHRC 2002
First Posted: August 26, 2009    Key Record Dates
Last Update Posted: August 26, 2009
Last Verified: August 2009
Keywords provided by University Hospital, Toulouse:
anticoagulation clinics
randomized comparison
Additional relevant MeSH terms:
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Hemostatic Disorders
Blood Coagulation Disorders
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders