Benefit of Self-Monitoring of Anticoagulation Instrument - Full Text View

Purpose

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Other, 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

Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:

Economic and medical evaluation of self-monitoring of coagulation compared with conventional follow-up of anticoagulation in a population recently fitted with mechanical heart valves. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

- the impact of complications stemming from oral anticoagulant treatment (bleeding, thromboembolic episodes or death) within a population recently fitted with a mechanical hear valve. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
the proportion of monthly measurements of INR within the designated range [ Time Frame: 12 months ] [ Designated as safety issue: No ]
the inherent cost of each strategy of anticoagulation monitoring [ Time Frame: 12 month ] [ Designated as safety issue: No ]

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	Device: Conventional follow-up of anti-coagulation At least, one follow-up of INR per month. Measured in laboratory.
2: Experimental Self-monitoring of anticoagulation	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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Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

adults
patients fitted with one or more mechanical heart valves either alone or in combination with myocardial revascularization
oral anticoagulant treatment
patients with social security cover
written informed consent signed by both patient and investigator

Exclusion Criteria:

women pregnant or liable to become pregnant during the study
nursing women
patients unable to master the self-monitoring procedures
individuals under judicial control or enquiry
patients consuming excessive amounts of alcohol ((>40g/j for men et >30g/j for women femmes ; 1 glass = 10g)
patients on dialysis
patients with incomplete understanding of instructions
blind patients and those unable to read
presence of circulating anticoagulant

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00506870

Contacts


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

Locations


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

Sponsors and Collaborators

University Hospital, Bordeaux

Ministry of Health, France

Hoffmann-La Roche

Biodis

Investigators


Study Director:	Raymond ROUDAUT, Pr	University Hospital, Bordeaux

Study Chair:	Geneviève CHENE, Pr	University Hospital, Bordeaux

Principal Investigator:	Raymond ROUDAUT, Pr	University Hospital, Bordeaux

More Information

Responsible Party:	University Hospital, Bordeaux ( Jean-Pierre LEROY / Clinical Research and Innovation Director )
Study ID Numbers:	CHUBX2006/04, 2006/019
First Received:	July 23, 2007
Last Updated:	August 25, 2008
ClinicalTrials.gov Identifier:	NCT00506870
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Bordeaux:

Heart Valve Prosthesis Implantation

INR self monitoring

cost benefit evaluation

ClinicalTrials.gov processed this record on September 22, 2008

Sponsors and Collaborators:	University Hospital, Bordeaux Ministry of Health, France Hoffmann-La Roche Biodis
Information provided by:	University Hospital, Bordeaux
ClinicalTrials.gov Identifier:	NCT00506870