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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00966290 |
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Date of registration:
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21/08/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Anticoagulant Clinics and Vitamin K Antagonists
COMPARE |
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Scientific title:
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Anticoagulant Clinic-based Shared-care Versus Usual Cate Management of Vitamin K Antagonist Therapy : the Open, Randomized Multicenter Study |
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Date of first enrolment:
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February 2003 |
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Target sample size:
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1006 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00966290 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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France
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Contacts
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Name:
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Bernard Boneu, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital, Toulouse |
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Name:
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Patrick Mismetti, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital Saint-Etienne |
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Name:
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Alessandra BURA-RIVIERE, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital, Toulouse |
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Name:
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Henri Boccalon, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital, Toulouse |
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Key inclusion & exclusion criteria
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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)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Blood Coagulation Disorders
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Intervention(s)
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Drug: Anticoagulant (warfarin, acenocoumarol, fluindione)
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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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.]
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Secondary ID(s)
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PHRC 2002
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0200301
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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