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Trial record 33 of 157 for:    warfarin AND Vitamin K

Anticoagulant Clinics and Vitamin K Antagonists (COMPARE)

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ClinicalTrials.gov Identifier: NCT00966290
Recruitment Status : Completed
First Posted : August 26, 2009
Last Update Posted : August 26, 2009
Sponsor:
Information provided by:
University Hospital, Toulouse

Tracking Information
First Submitted Date  ICMJE August 21, 2009
First Posted Date  ICMJE August 26, 2009
Last Update Posted Date August 26, 2009
Study Start Date  ICMJE February 2003
Actual Primary Completion Date December 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 25, 2009)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 25, 2009)
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. ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Anticoagulant Clinics and Vitamin K Antagonists
Official Title  ICMJE Anticoagulant Clinic-based Shared-care Versus Usual Cate Management of Vitamin K Antagonist Therapy : the Open, Randomized Multicenter Study
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.

Detailed Description

Study design

The COMPARE (Comparison of Oral anticoagulation Monitoring Practice: A Randomized Evaluation) study is an open, centrally randomized, multicenter, prospective, controlled study comparing two models of vitamin K antagonist (VKA) therapy management. Written informed consent is obtained from each patient and general practitioner before randomization.

Setting and participants

The study concerned patients referred to the anticoagulation clinic (ACC) of various University Hospitals in France. Eligible patients are consecutive patients who were starting a course of VKA therapy scheduled to last for at least three months.

Randomization and interventions

All eligible patients are evaluated by a physician specialized in vascular medicine or hematology. After their demographic characteristics and medical history had been recorded, they are randomized to one of the models of VKA therapy management, either UC management or ACC-based shared-care management. Randomization is stratified by center; the list of randomization is computer-generated according to a permuted block design with a block size of four, six or eight. General practitioners are informed of the outcome of randomization by a standardized letter. In patients randomized to the UC management group, the monitoring of VKA therapy is left to the general practitioner's discretion according to his/her preferences and habits. Patients randomized to the ACC-based shared-care management group receive a standardized educational package; moreover, each biological laboratory measuring INR values for the patients of this group is contacted to explain the importance of rapid restitution of the results. A computer-generated dose proposal is also given, both by telephone and by fax, to the general practitioners who follow up patients randomized to the ACC-based shared-care management group; however, they were free to accept or ignore this proposal. All patients receive a logbook in which to record their INR results.

Study outcomes

The primary study outcome is a composite of symptomatic and objectively confirmed thromboembolic or major bleeding events at 18 months. Thromboembolic events are acute myocardial infarction, stroke, peripheral arterial occlusion, deep-vein thrombosis or pulmonary embolism. Major bleeding events are fatal bleeding, or any bleeding leading to functional impairment or requiring hospitalization. All-cause mortality is a secondary outcome measure. All outcomes are reviewed by a central, independent adjudication committee, the members of which were unaware of the patients' study group.

The quality of anticoagulation control is evaluated in all randomized patients with at least two INR measurements. This parameter is assessed by determining (1) the percentage of INR within the target range, (2) the percentage of time during which the INR was within the target range in relation to the total length of the observation period, according to the linear interpolation method, and (3) the variability index (σ2).

Statistical analysis

This is a superiority study in which we hypothesize that ACC-based shared-care management would reduce the cumulative incidence of the primary study outcome by 50% compared with UC management. On the basis of previous non-controlled studies, we assumed that the cumulative incidence of the primary study outcome would be 10% in patients assigned to the UC management group. Given these assumptions, we calculated that the recruitment of 600 patients per group would allow confirmation of the statistical hypothesis with 90% power and a two-sided, type I error of 0.05.

The statistical analyses will be performed on all randomized patients on an intention-to-treat basis.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Blood Coagulation Disorders
Intervention  ICMJE
  • 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
  • Drug: Anticoagulant (warfarin, acenocoumarol, fluindione)
    Usual care group
    Other Name: Patients whose anticoagulation is managed by the general practitioner
Study Arms  ICMJE
  • Experimental: ACC group
    Anticoagulant clinic-based shared-care group
    Intervention: Drug: Anticoagulant (warfarin, acenocoumarol, fluindione)
  • Active Comparator: UC group
    Usual care group
    Intervention: Drug: Anticoagulant (warfarin, acenocoumarol, fluindione)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 25, 2009)
1006
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2006
Actual Primary Completion Date December 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00966290
Other Study ID Numbers  ICMJE 0200301
PHRC 2002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party LLAU ME, University Hospital Toulouse
Study Sponsor  ICMJE University Hospital, Toulouse
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account University Hospital, Toulouse
Verification Date August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP