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Sponsors and Collaborators: |
University Hospital, Bordeaux Ministry of Health, France Hoffmann-La Roche Biodis |
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Information provided by: | University Hospital, Bordeaux |
ClinicalTrials.gov Identifier: | NCT00506870 |
To evaluate the benefit economic and medical of self-monitoring of coagulation compared with conventional follow-up of anticoagulation in a population recently fitted with mechanical heart valves.
Condition | Intervention |
---|---|
Mechanical Prosthetic Heart Valve Implantation Patient Self Monitoring of Oral Anticoagulent Therapy |
Device: INRatio / Coaguchek XS Device: Conventional follow-up of anti-coagulation |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Economic and Medical Evaluation of Self-Monitoring of Anticoagulation in a Population of Patients Recently Fitted With a Mechanical Heart Valve Compared to Conventional Anticoagulation Follow-up |
Estimated Enrollment: | 1050 |
Study Start Date: | June 2007 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: No Intervention
Conventional follow-up of anticoagulation
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Device: Conventional follow-up of anti-coagulation
At least, one follow-up of INR per month. Measured in laboratory.
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2: Experimental
Self-monitoring of anticoagulation
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Device: INRatio / Coaguchek XS
INR measured by patient himself using INRation or Coaguchek device. And one follow-up of INR per month, measured in laboratory.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Raymond ROUDAUT, Pr | 33(0)557 65 68 14 | raymond.roudaut@pu.u-bordeaux2.fr |
Contact: Christel DUPRAT | 33(0)557 65 67 43 | christel.duprat@chu-bordeaux.fr |
France | |
Pôle Cardio-Thoracique - Hôpital Cardiologique du Haut-Lévêque - CHU de Bordeaux - Avenue de Magellan | Recruiting |
PESSAC Cedex, France, 33604 | |
Contact: Raymond ROUDAUT, Pr 33(0)557656814 raymond.roudaut@pu.u-bordeaux2.fr | |
Contact: Christel DUPRAT 33(0)557656743 christel.duprat@chu-bordeaux.fr | |
Principal Investigator: Raymond ROUDAUT, Pr |
Study Director: | Raymond ROUDAUT, Pr | University Hospital, Bordeaux |
Study Chair: | Geneviève CHENE, Pr | University Hospital, Bordeaux |
Principal Investigator: | Raymond ROUDAUT, Pr | University Hospital, Bordeaux |
Responsible Party: | University Hospital, Bordeaux ( Jean-Pierre LEROY / Clinical Research and Innovation Director ) |
Study ID Numbers: | CHUBX2006/04, 2006/019 |
Study First Received: | July 23, 2007 |
Last Updated: | August 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00506870 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Heart Valve Prosthesis Implantation INR self monitoring cost benefit evaluation |